Medical device registration in India
How RegaCats can help manufacturers & importers in India?
The consultancy for medical device regulatory affairs & CDSCO medical device compliances
Regacats consultancy assistance for medical device registration in India
RegaCats supports manufacturers and importers for CDSCO regulations, compliances, registration process, manufacturing & import license. We handle everything from preparing necessary forms, such as (Form MD-14, MD-15 for importers) & (MD-3, MD-7, MD-9, for manufacturers) & (MD-4, MD-8, MD-10 for loan license) for medical devices, to managing the certification process. Our team ensures documents meet regulatory standards and provides support during inspections and audits. With our expertise, regulatory compliance is simplified.
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How to get medical device import license?
How to get medical device manufacturing License?
Medical Device Registration consultant in India for Manufacturers and Importers
Application submission assistance
Document preparation assistance for medical device registration
Inspection & verification Assistance
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Medical device registration types in India – Regacats Expertise
Regacats Solution Consultancy helps for all 3 types of medical device registrations in India
- Non-Notified Medical Device Registration
- Notified Medical Device Registration
- In Vitro Diagnostic (IVD) Medical Device Registration
In the context of CDSCO, there are primarily three types of registrations: Non-Notified Medical Device Registration, which covers devices not specifically listed under notifications requiring mandatory pre-market approval; Notified Medical Device Registration, which pertains to devices that the CDSCO has officially notified, mandating pre-market regulatory clearance; and In Vitro Diagnostic (IVD) Medical Device Registration, specifically for reagents, instruments, and systems intended for the examination of specimens derived from the human body, thus requiring a separate regulatory pathway under CDSCO. For more information on medical device registration types – this is the correct page for info.
RegaCat’s efficient Timeline in Medical Device registration – Time it takes
| Device Risk Class | Typical Review Time | Potential Additional Time Factors |
|---|---|---|
| Class A & B | 3 – 6 months | Inspections (1 – 2 months) |
| Class C & D | 6 – 12 months | TAC consultations, Inspections (2 – 3 months) |
Medical Device Rules, 2017 (and Amendments) : Consultant for medical device registration process
Medical Device Registration: Streamlining via SUGAM Portal Operations
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What are the documents required in medical device registration
The specific documents required for medical device registration with CDSCO vary depending on the risk classification of the device (A, B, C, or D) and whether it’s for import or domestic manufacturing. However, here’s a general list of commonly required documents
Who can apply for CDSCO certificate for medical device registration?
The Central Drugs Standard Control Organization (CDSCO) license is a mandatory requirement for medical device registration in India. it is necessary for both medical device manufacturers and importers to obtain licenses to assure the buyers for their medical devices follow CDSCO medical device guidelines.
Medical Device Manufacturing License for manufacturers
For manufacturers pursuing the medical device manufacturing license for manufacturers in India, the Central Drugs Standard Control Organisation (CDSCO), under the Medical Devices Rules, 2017, sets fees in Indian Rupees (INR) based on device risk class (A, B, C, or D). My research, sourced from the CDSCO website and X discussions, indicates that the medical device manufacturing license for manufacturers costs ₹5,000 per site for Class A or B devices and ₹50,000 for Class C or D, with per-device fees of ₹500 and ₹1,000, respectively. Annual retention fees align with these initial costs. Manufacturers must also budget for compliance costs, such as ISO 13485 certification and post-market surveillance, to meet medical device manufacturing license for manufacturers requirements. Regularly monitoring the CDSCO portal ensures adherence to the latest medical device manufacturing license for manufacturers fee structure.
Medical Device Import License for Importers
For importers navigating the medical device import license for importers in India, the Central Drugs Standard Control Organisation (CDSCO) mandates fees in US Dollars (USD), tailored to device class (A, B, C, or D) and type (non-IVD or IVD). My research, based on the CDSCO portal and X discussions, highlights that the medical device import license for importers costs start at $1,000 per site for Class A non-IVD devices, escalating to $3,000 for Class C or D, with per-device fees ranging from $50 to $1,500 for non-IVDs and $10 to $500 for IVDs. Annual retention fees match these initial costs. Importers must also account for compliance expenses like labeling and clinical evaluations to secure the medical device import license for importers. Regularly checking the CDSCO website ensures compliance with the latest medical device import license for importers requirements.
CDSCO Documentation and Submission Services for Medical Devices
Comprehensive CDSCO Documentation Preparation for Medical Devices
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Technical documentation preparation, including device descriptions and specifications
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Development of risk management files, including risk assessments and mitigation strategies
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Compilation of clinical trial data and reports (if applicable)
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Creation of post-market surveillance plans and reports
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Preparation of labeling and packaging materials compliant with CDSCO requirements
Efficient CDSCO Application Submission Management for Medical Device Approval
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Submission of applications through CDSCO’s online portals, including SUGAM and other relevant platforms
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Ensuring timely and accurate submissions to meet CDSCO’s regulatory requirements
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Providing guidance on CDSCO’s documentation and submission requirements for medical devices
Post-Submission Support and CDSCO Liaison Services
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Tracking and responding to CDSCO queries and requests for additional information
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Providing support for CDSCO audits and inspections
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Liaising with CDSCO officials to clarify regulatory requirements and ensure smooth approval processes
Why Choose RegaCats for Medical Device CDSCO Compliance?
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Have you any questions about regulatory or compliances in medical or food industry? Feel free to ask, our experts are at your service. Generally we reply instantly.
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+91 097114 67307
Selling without this permission is strictly prohibited and can lead to severe CDSCO penalties on manufacturers & importers, such as fines or product seizures. For manufacturers, complying with CDSCO standards can be challenging due to lack of knowledge, application procedure and compliance handling which can cause lengthy approval timelines, which often delay market entry. Despite these pain points, registration is essential for legal market access and maintaining trust in India’s healthcare system. (citation: please refer to the official CDSCO website.)
Medical device approval with CDSCO is vital because it ensures that devices meet strict safety and efficacy standards, protecting patients and healthcare providers from potential risks. Manufacturers and importers are primarily responsible for applying for MD registration (Medical device registration), while suppliers and brand owners must ensure the devices they handle are compliant.
Navigating the complex regulatory landscape of medical device registration in India can be challenging, but partnering with a reliable CDSCO consultant can simplify the process. By finding the right CDSCO consultant, initiating a consultation, and connecting with CDSCO regulatory experts, you can ensure that your medical device meets all regulatory requirements in India.
Throughout this guide, we’ve outlined the importance of:
- Finding a CDSCO consultant with extensive experience and expertise in medical device registration
- Initiating a consultation to discuss your specific regulatory needs
- Connecting with CDSCO regulatory experts to stay updated on regulatory changes and compliance requirements
By following these steps and partnering with a reputable CDSCO consultancy service like Regacats, you can:
- Ensure seamless compliance with CDSCO regulations
- Avoid potential compliance issues and penalties
- Bring your medical device to market in India efficiently and effectively
Remember, regulatory compliance is an ongoing process that requires continuous monitoring and updating. Stay informed, stay compliant, and succeed in the Indian medical device market.
Visit our website contact page to learn more about our CDSCO Medical Device Regulatory Affairs services and contact us for a free consultation. Alternatively, support is available on the following number also.
However this can guide you how you can select any CDSCO consultant for medical device registration and compliances afterward
Consultant : Akshay
Phone Number : 097114 67307
As consultancy RegaCats offers a comprehensive range of services, including regulatory consulting, training, and support throughout the entire product lifecycle.
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Simplified Regulatory Compliance: Consultants like RegaCats have in-depth knowledge of CDSCO regulations, ensuring that your medical devices meet all the necessary requirements, making the compliance process smoother and less cumbersome.
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Faster Time-to-Market: With their expertise, you can expedite the regulatory approval process, minimizing delays and getting your product to market sooner, giving you a competitive edge.
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Reduced Costs: Efficient processes and strategic guidance from consultants help avoid costly mistakes and unnecessary rework, saving you time and money.
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Global Market Access: Consultants can help you navigate international regulations, expanding your reach to new markets, including the US, Europe, and other countries.
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Personalized Support: Reputable consultants like RegaCats offer tailored services, understanding your unique needs and goals, providing regular updates and support throughout the registration process.
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Increased Success Rate: With their experience and knowledge, consultants can help you avoid common pitfalls and increase your chances of successful registration and approval.
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Peace of Mind: By outsourcing regulatory affairs to a consultant, you can focus on your core business, knowing that your regulatory compliance is in good hands.
RegaCats can guide you through the entire CDSCO approval process, from initial application submission to obtaining final approvals.
Pre-Registration Support
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Device Classification: RegaCats helps determine the correct classification of your medical device, ensuring you follow the right regulatory pathway.
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Regulatory Strategy: They develop a tailored regulatory strategy, outlining the necessary steps for approval.
Registration and Approval
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CDSCO Registration: RegaCats assists with the registration process, ensuring accurate and complete submissions.
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Medical Device License: They help obtain the necessary licenses for manufacturing, importing, or selling medical devices in India.
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Clinical Trial Support: RegaCats provides guidance on clinical trial requirements, if necessary, and assists with trial applications.
Documentation and Submission
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Technical Documentation: They help prepare and review technical documentation, such as device descriptions, specifications, and labeling.
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Submission Preparation: RegaCats ensures that all necessary documents are prepared and submitted to CDSCO in the required format.
Post-Approval Support
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Post-Market Surveillance: They assist with post-market surveillance requirements, ensuring ongoing compliance.
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Variations and Amendments: RegaCats helps with variations and amendments to existing approvals, if needed.
Additional Services
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Training and Education: They provide training and education on CDSCO regulations and requirements.
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Audits and Compliance: RegaCats conducts audits and ensures compliance with CDSCO regulations and international standards.
Staying updated on regulatory changes is vital. RegaCats can keep you informed about the latest CDSCO updates and ensure your manufacturing practices remain compliant with the evolving regulatory landscape. For further assistance for medical devices approval this link can be helpful https://regacats.in/medical-device-regulatory-affairs/ , https://www.cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications
Ongoing CDSCO regulatory changes and updates that manufacturers need to be aware of include:
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Extension of Schedule M: The CDSCO has notified an extension of Schedule M, which deals with the good manufacturing practices (GMP) for medical devices.
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Banning of Certain Drugs: The CDSCO has banned the use of certain drugs, including Nimesulide for animal use, Etodolac, and 156 fixed-dose combinations (FDCs).
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Medical Device Testing Officers (MDTO): The CDSCO has notified the appointment of MDTOs for laboratories, which will be responsible for testing medical devices.
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Registration of Clinical Research Organizations (CROs): The CDSCO has notified the registration requirements for CROs, which will be responsible for conducting clinical trials.
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Amendments to the Drugs Rules, 1945: The CDSCO has made several amendments to the Drugs Rules, 1945, including the inclusion of new drugs in Schedule H1 and the omission of certain drugs from Schedule P1.
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Medical Device Regulations: The CDSCO has notified several regulations related to medical devices, including the exemption of certain Class A medical devices from the licensing regime and the insertion of new rules for the suspension and cancellation of licenses.
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Labeling and Packaging Requirements: The CDSCO has notified new labeling and packaging requirements for medical devices, including the mandatory use of barcodes or QR codes on the labels of certain medical devices.
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Post-Market Surveillance: The CDSCO has emphasized the importance of post-market surveillance for medical devices and has notified requirements for manufacturers to report adverse events and conduct periodic safety updates.
Post-market surveillance is crucial for ensuring the continued safety and effectiveness of your devices. RegaCats can advise on CDSCO post-market surveillance requirements and help you develop a compliant surveillance plan. Post-market surveillance activities include adverse event reporting, field safety corrective actions, and periodic product reviews.
Checklist for the grant of medical devices
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Reporting Adverse Events: Manufacturers, healthcare providers, and patients must report any adverse events, such as patient injuries or product malfunctions.
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Post-Market Surveillance Studies: Manufacturers are responsible for conducting post-market surveillance studies to monitor device performance and identify potential safety concerns.
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Data Collection and Analysis: Manufacturers must collect and analyze data from various sources, including adverse event reports, patient feedback, and device performance data.
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Corrective and Preventive Actions: Manufacturers must take corrective and preventive actions based on the data collected and analyzed during post-market surveillance.
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Submission of Post-Market Surveillance Reports: Manufacturers must submit post-market surveillance reports to the CDSCO, which includes data on adverse events, device performance, and corrective actions taken.
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Implementation of a Quality Management System: Manufacturers must implement a quality management system that covers all aspects of production, from design and development to distribution and post-market monitoring.
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Compliance with ISO Standards: Manufacturers must comply with ISO standards to ensure global compatibility and acceptance of Indian medical devices.
RegaCats can help you implement and maintain a robust quality management system that complies with CDSCO GMP requirements, ensuring the safety and quality of your manufactured devices.
Pre-Audit Preparation
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GMP Gap Analysis: RegaCats conducts a thorough gap analysis to identify areas of non-compliance with CDSCO’s GMP requirements.
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Corrective Action Plan: They help develop a corrective action plan to address the identified gaps and ensure compliance.
GMP Compliance
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Documentation Review: RegaCats reviews your facility’s documentation, including SOPs, policies, and records, to ensure compliance with GMP requirements.
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Facility Inspection: They conduct a thorough inspection of your facility to identify any potential GMP compliance issues.
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Staff Training: RegaCats provides training to your staff on GMP principles, ensuring they understand the requirements and can implement them effectively.
Quality Management System (QMS)
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QMS Development: RegaCats helps develop a QMS that meets CDSCO’s GMP requirements, including procedures for document control, record-keeping, and corrective action.
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QMS Implementation: They assist with implementing the QMS, ensuring it is integrated into your facility’s operations.
Audit Support
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Mock Audits: RegaCats conducts mock audits to prepare your facility for CDSCO inspections.
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Audit Response: They help respond to any audit findings, ensuring prompt and effective corrective actions.
Ongoing Compliance
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Regular Audits: RegaCats conducts regular audits to ensure ongoing compliance with CDSCO’s GMP requirements.
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Compliance Monitoring: They monitor your facility’s compliance with GMP requirements, identifying areas for improvement.
Clinical trials may be necessary for certain medical devices. RegaCats can guide you through the CDSCO clinical trial application process and ensure compliance with all relevant requirements.
Pre-Clinical Trial Requirements
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Device Classification: Determine the classification of the medical device, which will dictate the regulatory requirements.
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Technical Documentation: Prepare technical documentation, including device description, specifications, and labeling.
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Animal Studies: Conduct animal studies to evaluate the safety and performance of the device.
Clinical Trial Approval
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Clinical Trial Application: Submit a clinical trial application to the CDSCO, including the protocol, investigator brochure, and informed consent form.
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Ethics Committee Approval: Obtain approval from an ethics committee, which reviews the trial protocol and ensures compliance with ethical standards.
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CDSCO Approval: Obtain approval from the CDSCO, which reviews the clinical trial application and ensures compliance with regulatory requirements.
Clinical Trial Conduct
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Good Clinical Practice (GCP): Conduct the clinical trial in accordance with GCP principles, which ensure the quality and integrity of the trial data.
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Informed Consent: Obtain informed consent from all trial participants, which ensures they understand the risks and benefits of the trial.
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Data Management: Manage trial data in accordance with regulatory requirements, which ensures the accuracy and integrity of the data.
Post-Clinical Trial Requirements
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Clinical Trial Report: Submit a clinical trial report to the CDSCO, which summarizes the trial results and conclusions.
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Device Registration: Register the medical device with the CDSCO, which requires submitting technical documentation and clinical trial data.
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Post-Market Surveillance: Conduct post-market surveillance, which monitors the safety and performance of the device after it is marketed.
Additional Requirements
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Medical Device Rules, 2017: Comply with the Medical Device Rules, 2017, which regulate the manufacture, import, and sale of medical devices in India.
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ISO Standards: Comply with ISO standards, such as ISO 14155 (Clinical investigation of medical devices) and ISO 13485 (Medical devices – Quality management systems).
RegaCats can assist you in preparing the comprehensive technical documentation package required for CDSCO registration, including design documentation, risk management plans, and performance data.
Device Description
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Device Name and Classification: Name and classification of the device, including its intended use.
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Device Description: Detailed description of the device, including its design, materials, and functionality.
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Device Specifications: Specifications of the device, including its dimensions, weight, and performance characteristics.
Design and Development
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Design Documents: Design documents, including drawings, diagrams, and schematics.
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Design Verification and Validation: Reports on design verification and validation, including testing and inspection results.
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Risk Management File: Risk management file, including identification of hazards, risk assessment, and mitigation measures.
Manufacturing and Quality Control
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Manufacturing Process: Description of the manufacturing process, including materials, equipment, and procedures.
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Quality Control Procedures: Quality control procedures, including inspection, testing, and validation.
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Sterilization and Packaging: Description of sterilization and packaging procedures.
Clinical Evaluation
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Clinical Evaluation Report: Clinical evaluation report, including clinical trial results, literature reviews, and expert opinions.
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Clinical Trial Data: Clinical trial data, including patient data, study protocols, and informed consent forms.
Labeling and Instructions for Use
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Labeling: Labels and labeling information, including warnings, precautions, and instructions for use.
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Instructions for Use: Instructions for use, including user manuals, guides, and training materials.
Other Documents
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CE Certificate: CE certificate, if applicable.
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ISO Certificates: ISO certificates, such as ISO 13485.
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Free Sale Certificate: Free sale certificate, if applicable.
Accurate classification is crucial for the regulatory process. RegaCats can help you classify your medical device according to the CDSCO classification system.
Classification Process
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Device Description Review: RegaCats reviews your device description, including its intended use, design, and functionality.
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Risk Assessment: They conduct a risk assessment to determine the level of risk associated with your device.
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Classification Determination: Based on the review and risk assessment, RegaCats determines the classification of your device according to CDSCO regulations.
Classification Categories
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Low-Risk Devices (Class A): RegaCats helps determine if your device falls under Class A, which includes low-risk devices such as bandages and gloves.
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Moderate-Risk Devices (Class B): They assist in determining if your device falls under Class B, which includes moderate-risk devices such as surgical instruments and diagnostic equipment.
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High-Risk Devices (Class C): RegaCats helps determine if your device falls under Class C, which includes high-risk devices such as implants and life-supporting devices.
Benefits of Accurate Classification
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Compliance with Regulations: Accurate classification ensures compliance with CDSCO regulations, reducing the risk of non-compliance and associated penalties.
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Streamlined Regulatory Process: Knowing the correct classification of your device streamlines the regulatory process, saving time and resources.
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Market Access: Accurate classification is essential for market access, as it determines the level of regulatory oversight and the requirements for approval.
Ongoing Support
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Classification Updates: RegaCats provides updates on any changes to CDSCO regulations or classification rules, ensuring ongoing compliance.
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Device Modifications: They assist with reclassification if your device undergoes modifications or changes in intended use.
Key requirements include facility registration, compliance with Good Manufacturing Practices (GMP), and obtaining necessary approvals for your products. RegaCats can guide you through the CDSCO requirements for manufacturing medical devices in India, including facility registration, quality management system implementation, and compliance with Good Manufacturing Practices (GMP).
Quality Management System
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Your manufacturing site must have a quality management system certified with ISO 13485 or ICMED 13485 ¹.
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This system ensures you consistently deliver medical devices that meet customer expectations and regulatory requirements.
Licensing
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You’ll need to obtain a manufacturing license from the State Licensing Authority for Class A and B devices or the Central Licensing Authority for Class C and D devices ².
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The license application process involves submitting forms, paying fees, and undergoing audits.
Device Classification
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Medical devices are classified into four categories based on their risk level: Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk) ².
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You’ll need to determine the classification of your device and comply with the relevant requirements.
Manufacturing and Testing
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Your manufacturing facility must meet Good Manufacturing Practices (GMP) standards ¹.
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You’ll need to conduct rigorous testing and validation to ensure your devices meet specified standards.
Risk Management
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You must identify, assess, and mitigate potential risks associated with your devices ¹.
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This involves documenting risk assessments and mitigation strategies to ensure patient safety.
Audit and Inspection
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Your facility will be subject to audits and inspections by the State Licensing Authority or Central Licensing Authority ¹.
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You’ll need to ensure your facility is always ready for inspection and that you have a system in place for addressing any non-compliances.
Contact RegaCats today for a free consultation to discuss your specific requirements.
Contact Information
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Website: Visit the RegaCats website at https://regacats.in/contact-us/ to learn more about their services and expertise.
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Phone: Call RegaCats at
097114 67307to speak directly with a representative.
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Email: Send an email to contact@regacats.in to inquire about their services or schedule a consultation.
Contact Form
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Online Form: Fill out the contact form on the RegaCats website to submit your inquiry or request a consultation.
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Device type and classification
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Import volume and frequency
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Regulatory compliance requirements
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Any specific challenges or concerns you’re facing
RegaCats may offer training programs to help you and your team understand CDSCO regulations and best practices, our process includes the overall coverage of understanding the compliances and goals of CDSCO.
RegaCats can guide you through the entire process of obtaining a CDSCO license for importing and distributing medical devices in India.
Licensing Application Preparation
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Formulation of Application: RegaCats helps prepare and formulate the licensing application, ensuring accuracy and completeness.
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Documentation Support: They assist in collecting and organizing the required documents, including technical dossiers, free sale certificates, and ISO certifications.
Compliance with CDSCO Regulations
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Regulatory Guidance: RegaCats provides guidance on CDSCO regulations, ensuring compliance with the Medical Device Rules, 2017.
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Device Classification: They assist in classifying medical devices according to the CDSCO classification system.
Submission and Follow-up
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Application Submission: RegaCats submits the licensing application to the CDSCO on your behalf.
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Follow-up and Clarifications: They follow up with the CDSCO to address any queries or clarifications required during the review process.
Post-Licensing Support
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License Renewal: RegaCats assists with license renewal, ensuring timely submission of renewal applications.
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Compliance Monitoring: They provide ongoing compliance monitoring, ensuring adherence to CDSCO regulations and license conditions.
Additional Services
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Regulatory Strategy: RegaCats develops a regulatory strategy tailored to your business needs, ensuring efficient and compliant market entry.
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Training and Education: They provide training and education on CDSCO regulations, licensing requirements, and compliance best practices.
If you face a challenging CDSCO decision, RegaCats can provide expert guidance and support throughout the appeal process.
Appeal Preparation
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Review of CDSCO Decision: RegaCats reviews the CDSCO decision, identifying the grounds for appeal.
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Documentation Support: They assist in collecting and organizing the required documents, including technical dossiers, test reports, and clinical data.
Regulatory Guidance
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CDSCO Regulations: RegaCats provides guidance on CDSCO regulations, ensuring compliance with the Medical Device Rules, 2017.
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Appeal Procedures: They explain the appeal procedures, including the required format, content, and timelines.
Appeal Submission
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Drafting Appeal Letter: RegaCats helps draft a comprehensive appeal letter, addressing the grounds for appeal and providing supporting evidence.
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Submission to CDSCO: They submit the appeal to the CDSCO, ensuring timely and proper submission.
Representation and Follow-up
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Representation: RegaCats represents you in discussions with the CDSCO, ensuring your interests are protected.
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Follow-up: They follow up with the CDSCO to track the appeal’s progress, addressing any additional queries or concerns.
Strategic Guidance
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Regulatory Strategy: RegaCats develops a regulatory strategy tailored to your business needs, ensuring efficient and compliant market entry.
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Risk Mitigation: They help mitigate potential risks associated with the appeal, ensuring you’re prepared for any outcome.
Additional Services
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Training and Education: RegaCats provides training and education on CDSCO regulations, appeal procedures, and compliance best practices.
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Ongoing Compliance Support: They offer ongoing compliance support, ensuring you maintain compliance with CDSCO regulations and licensing conditions.
Staying updated on regulatory changes is essential. RegaCats can keep you informed about the latest CDSCO updates and ensure your import practices remain compliant with the evolving regulatory landscape.
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MedTech Mitra: The CDSCO and ICMR have launched MedTech Mitra to promote the development of affordable and accessible domestic medical devices and in-vitro diagnostics. This initiative provides MedTech innovators with strategic handholding support for clinical evaluation, regulatory facilitation, and new product uptake.
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Import License Renewal: The CDSCO has issued guidance on the process for medical device Import License renewal. This process is newly implemented, as the first round of Import Licenses issued under the new Rules will start to expire this year.
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Revised Schedule M: There have been recent updates to the Drugs and Cosmetics Act and Revised Schedule M, which aim to strengthen the regulatory system. These updates include capacity building, cadre expansion for Drugs and Medical Devices verticals, and dedicated training academies.
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Guidance Document for Safety Profile Submission: The CDSCO has released a guidance document to facilitate the submission of safety profiles of drugs by Marketing Authorization Holders (MAHs). This document defines the roles and responsibilities of CDSCO, State/UT Drugs Controller, NCC-PvPI, and IPC.
Maintaining accurate and complete records is crucial for demonstrating compliance. RegaCats can advise on CDSCO record-keeping requirements and help you develop a compliant record-keeping system.
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Retention Period: Records must be maintained for a minimum period of two years from the last entry .
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Record Keeping: Licensees must maintain records of all transactions, including sales, purchases, and storage of medical devices .
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Inspection Book: Licensees must maintain an inspection book in Form MD-43, which enables Medical Devices Officers to record their observations and defects noticed during inspections.
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Compliance with Good Distribution Practices: Licensees must comply with Good Distribution Practices (GDP) and maintain records of compliance.
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Device Master File: Importers must maintain a Device Master File (DMF) that contains detailed information about the medical device, including its design, manufacturing, and testing.
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Certificate of Compliance: Importers must obtain a Certificate of Compliance from the manufacturer, which certifies that the medical device complies with Indian regulations.
RegaCats can help you establish and maintain a robust quality management system aligned with CDSCO guidelines, ensuring your imported devices meet the highest safety and quality standards.
Quality Management System
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ISO 13485 Implementation: RegaCats assists in implementing an ISO 13485-certified quality management system, ensuring compliance with CDSCO requirements.
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Quality Policy and Procedures: They help develop a quality policy and procedures that align with CDSCO guidelines and international standards.
Device Testing and Validation
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Testing Protocol Development: RegaCats develops testing protocols to ensure compliance with CDSCO requirements and international standards.
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Validation and Verification: They assist in validating and verifying the performance of medical devices, ensuring they meet CDSCO guidelines and international standards.
Supplier Qualification and Audit
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Supplier Qualification: RegaCats helps qualify suppliers based on CDSCO guidelines and international standards.
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Supplier Audit: They conduct audits of suppliers to ensure compliance with CDSCO requirements and international standards.
Labeling and Packaging Compliance
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Labeling Review: RegaCats reviews labeling to ensure compliance with CDSCO guidelines and international standards.
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Packaging Compliance: They ensure packaging meets CDSCO requirements and international standards.
Post-Market Surveillance
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Adverse Event Reporting: RegaCats assists in reporting adverse events to the CDSCO, ensuring compliance with post-market surveillance requirements.
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Field Safety Corrective Actions: They help implement field safety corrective actions, ensuring the safety of medical devices in the market.
Training and Education
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Regulatory Training: RegaCats provides training on CDSCO regulations and guidelines, ensuring your team is knowledgeable and compliant.device
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Quality Management Training: They offer training on quality management principles and practices, ensuring your team is equipped to maintain a robust quality management system.
Post-market surveillance is crucial for ensuring the continued safety and effectiveness of imported devices because it allows for the ongoing monitoring of device performance and the identification of any potential safety issues after they have been placed on the market.
However, understanding and fulfilling post-market surveillance obligations can be challenging.
Regacats can help you understand your specific post-market surveillance responsibilities, including adverse event reporting, field safety corrective actions, and periodic safety updates. Importers are responsible for post-import activities, including proper storage, distribution, and recall procedures, all of which are critical for ensuring the safety and efficacy of the imported medical devices.
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Reporting Adverse Events: Manufacturers, healthcare providers, and patients must report any adverse events related to the medical device.
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Device Master File (DMF): Manufacturers must create a DMF for each medical device, which includes comprehensive product information, such as design, manufacturing, and testing data.
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Technical Documentation: Manufacturers must provide technical documentation, including device description, risk assessment, biocompatibility, clinical data, performance testing, labeling, and instructions for use.
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Quality Management System (QMS) Documentation: Manufacturers must have an ISO 13485-certified QMS in place and submit a Plant Master File (PMF) for each manufacturing site.
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Post-Market Surveillance Reports: Manufacturers must submit post-market surveillance reports to the CDSCO, which include data on adverse events, complaints, and device performance.
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Inspections and Audits: The CDSCO may conduct inspections and audits to ensure compliance with post-market surveillance requirements.
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Labeling and Packaging Compliance: Manufacturers must ensure that labeling and packaging comply with CDSCO regulations.
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Stability Testing: Manufacturers must conduct stability testing to ensure the device maintains its properties and characteristics over time.
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Declaration of Conformity: Manufacturers must provide a Declaration of Conformity, which attests that the device complies with CDSCO regulations.
MD (Medical devices) import approval under CDSCO regulatory can have varying timelines depends on what product you are importing and from where, however this is seen sometimes it takes 60-90 days if done quickly. However this duration can be increases under different circumstances. RegaCats can help you understand the expected timelines and develop a proactive import strategy to minimize delays.
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Registration Certificate (Form 41): The processing time for a Registration Certificate is typically around 2-3 months. (resource link)
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Import License (Form 10): The licensing authority will issue an import license within three months from the date of receipt of a proper application.
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New Drug Approvals: The scrutiny of documents for new drug approvals generally takes about one year.
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Post-Approval Changes: The timeline for processing applications for post-approval changes in import licenses is not explicitly stated, but it’s recommended to obtain prior approval from the CLA/SLA in case of major changes.
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CDSCO’s Targeted Timeline: The CDSCO aims to process applications within 90 days, as per a circular dated 30.05.2014.
RegaCats can assist you in preparing the necessary documentation for CDSCO import registration, the documents can include Power of Attorney, technical documentation, and clinical data (if applicable), export license, business registration related documents. Additionally, you may need to provide evidence of the foreign manufacturer’s compliance with applicable regulations in their country of origin. This is because the compliances of CDSCO and other country’s regulatory can be different or similar at some points.
Manufacturer’s Documents
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Free Sale Certificate (FSC): Issued by the competent authority of the country of origin.
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Certificate of Market Approval: From the country of origin.
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ISO 13485 Certificate: Certificate of compliance with ISO 13485 standard.
Device-Related Documents
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Device Master File (DMF): A comprehensive document containing detailed information about the device.
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Technical File: Containing technical specifications, drawings, and test reports.
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Labeling and Packaging Material: Samples of labeling and packaging material.
Importer’s Documents
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Import License Application: In the prescribed format (Form 10).
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Registration Certificate Application: In the prescribed format (Form 41).
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Authorized Representative Appointment Letter: Appointing an authorized representative in India.
Other Documents
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Undertaking by the Importer: Regarding compliance with CDSCO regulations.
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Power of Attorney: Authorizing the importer to act on behalf of the manufacturer.
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Certificate of Incorporation: Of the importer company in India.
Understanding the CDSCO classification system is crucial for import registration. RegaCats can help you classify your devices accurately and determine the appropriate regulatory pathway. At our consultancy we solve the complex classification at CDSCO for you so that our clients can experience the smooth CDSCO approvals.
Classification Categories
Class A: Low-Risk Devices
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Definition: Devices that pose a low risk to the patient or user.
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Examples: Bandages, gloves, surgical instruments, and manual wheelchairs.
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Regulatory Requirements: Least stringent, with minimal regulatory oversight.
Class B: Low-to-Moderate Risk Devices
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Definition: Devices that pose a low to moderate risk to the patient or user.
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Examples: Surgical masks, orthopedic implants, diagnostic equipment, and ultrasound machines.
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Regulatory Requirements: Moderate regulatory oversight, with requirements for clinical trials and quality management systems.
Class C: Moderate-to-High Risk Devices
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Definition: Devices that pose a moderate to high risk to the patient or user.
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Examples: Implantable devices, such as pacemakers, and diagnostic imaging equipment, such as MRI machines.
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Regulatory Requirements: More stringent regulatory oversight, with requirements for clinical trials, quality management systems, and post-market surveillance.
Class D: High-Risk Devices
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Definition: Devices that pose a high risk to the patient or user.
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Examples: Life-supporting devices, such as ventilators, and implantable devices with a high risk of failure.
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Regulatory Requirements: Most stringent regulatory oversight, with requirements for clinical trials, quality management systems, post-market surveillance, and regular audits.
Classification Factors
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Intended Use: The intended use of the device, including its purpose, target population, and expected benefits.
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Invasiveness: The degree of invasiveness of the device, including its contact with the body and potential for tissue damage.
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Duration of Use: The duration of use of the device, including its intended lifespan and potential for repeated use.
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Risk of Infection: The risk of infection associated with the device, including its potential for microbial contamination.
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Other Factors: Other factors, such as the device’s complexity, novelty, and potential for off-label use.
Classification Process
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Manufacturer’s Declaration: The manufacturer declares the device’s classification based on its intended use, design, and risk factors.
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CDSCO Review: The CDSCO reviews the manufacturer’s declaration and may request additional information or clarification.
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Classification Decision: The CDSCO makes a classification decision based on the available information and the device’s risk profile.
Key requirements include obtaining an import license from CDSCO regulatory, ensuring compliance with applicable standards, and adhering to post-import obligations. RegaCats can guide you through the complexities of CDSCO regulations for importing medical devices, ensuring compliance with all relevant requirements.
1. Registration and Licensing
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Registration Certificate (Form 41): Obtain a registration certificate from the CDSCO for each medical device.
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Import License (Form 10): Obtain an import license from the CDSCO for each shipment of medical devices.
2. Device Classification
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Classify Medical Devices: Classify medical devices into one of four categories (Class A, B, C, or D) based on their risk level.
3. Quality Management System (QMS)
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ISO 13485 Certification: Ensure that the manufacturer has an ISO 13485-certified QMS in place.
4. Labeling and Packaging
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Labeling Requirements: Comply with CDSCO labeling requirements, including labeling in English or Hindi.
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Packaging Requirements: Comply with CDSCO packaging requirements, including packaging material and labeling.
5. Technical Documentation
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Device Master File (DMF): Submit a DMF for each medical device, which includes detailed information about the device.
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Technical File: Submit a technical file for each medical device, which includes technical specifications, drawings, and test reports.
6. Clinical Trials and Testing
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Clinical Trials: Conduct clinical trials in India for certain medical devices, as required by the CDSCO.
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Testing and Validation: Ensure that medical devices are tested and validated according to CDSCO requirements.
7. Post-Market Surveillance
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Adverse Event Reporting: Report adverse events related to medical devices to the CDSCO.
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Post-Market Surveillance Reports: Submit post-market surveillance reports to the CDSCO.
8. Importer’s Responsibilities
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Authorized Representative: Appoint an authorized representative in India to handle regulatory affairs.
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Importer’s Declaration: Submit an importer’s declaration to the CDSCO, which includes information about the medical device and its importer.
9. Compliance with Other Regulations
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Compliance with Other Regulations: Comply with other relevant regulations in India, such as the Drugs and Cosmetics Act and the Medical Devices Rules.
Manufacturing-Related Documents:
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Manufacturing License: A copy of the manufacturing license issued by the State Licensing Authority.
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Good Manufacturing Practice (GMP) Certificate: A certificate demonstrating compliance with GMP guidelines.
Product-Related Documents:
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Product Formula: A detailed formula of the product, including all ingredients and their concentrations.
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Product Specifications: Specifications of the product, including its physical and chemical characteristics.
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Stability Study Report: A report demonstrating the stability of the product under various conditions.
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Safety Data Sheet (SDS): An SDS for each ingredient used in the product.
Labeling and Packaging Documents:
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Labeling Information: A copy of the labeling information, including the product name, ingredients, instructions for use, and any warnings or cautions.
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Packaging Information: Details of the packaging material, including its composition and specifications.
Regulatory-Related Documents:
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COS-1 Form: A completed COS-1 form, which is the application form for cosmetic registration. (check here)
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Undertaking and Declaration: An undertaking and declaration by the manufacturer or importer, stating that the product complies with Indian regulations.
Other Documents:
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Certificate of Analysis: A certificate of analysis for each batch of the product.
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Free Sale Certificate: A free sale certificate from the country of origin, demonstrating that the product is approved for sale in that country.