Compliance with the Central Drugs Standard Control Organization (CDSCO) is non-negotiable to ensure device safety and market access. Under the Medical Devices Rules, 2017, CDSCO regulates devices through medical device registration types in India: Non-Notified Medical Device Registration, Notified Medical Device Registration, and In Vitro Diagnostic (IVD) Medical Device Registration in India. These pathways, based on risk and intended use, dictate the regulatory rigor needed to penetrate India’s fast-growing healthcare sector. This blog unpacks each type, providing essential insights to navigate CDSCO compliance and seize market potential.

What are the types of medical device registration process in India

CDSCO categorizes medical device registrations into Non-Notified, Notified, and IVD types to regulate based on risk, intended use, and public health impact, ensuring safety, efficiency, and global alignment.

Non-Notified Medical Device Registration

  • This category covers medical devices that are not specifically listed under the notified categories by the CDSCO. These devices still require registration to ensure basic safety and quality standards are met.
  • The registration process for non-notified devices is generally less stringent than for notified devices, but it still involves submitting relevant documentation and demonstrating compliance with applicable standards.
  • These devices are risk class A or B.

Notified Medical Device Registration

  • This category includes medical devices that the CDSCO has identified as requiring stricter regulatory oversight due to their higher risk levels.
  • These devices are specifically listed in the notified categories and undergo a more rigorous registration process, including thorough evaluation of safety, efficacy, and performance data.
  • These devices are risk class C or D.
  • The process involves detailed documentation, clinical evaluation (if required), and adherence to specific standards set by the CDSCO.

In Vitro Diagnostic (IVD) Medical Device Registration

  • This category pertains to devices used for in vitro diagnostic purposes, such as diagnostic kits, reagents, and instruments.
  • IVDs are subject to specific regulatory requirements due to their critical role in disease diagnosis and monitoring.
  • The registration process involves demonstrating the analytical and clinical performance of the IVD, as well as ensuring compliance with relevant quality management system standards.
  • IVD devices are also classified into risk classes.

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Medical Device Registration Types in India Under CDSCO : Resource collection with information

Why Does CDSCO Categorize Medical Device Registration Types in India?

  • Regulates devices based on risk level, intended use, and public health impact, as detailed on the CDSCO website.
  • Employs a risk-based approach aligned with global standards set by the International Medical Device Regulators Forum (IMDRF).
  • Non-Notified Devices (Class A/B): Lighter regulation for low-risk items (e.g., thermometers, bandages) to encourage innovation, according to the Medical Devices Rules, 2017.
  • Notified Devices (Class C/D): Stringent pre-market approval for high-risk devices (e.g., stents, pacemakers), as mandated by CDSCO regulations.
  • IVD Devices: Performance validation needed for diagnostic tools (e.g., HIV test kits) due to their critical role, as per CDSCO guidelines for IVDs.
  • Supports patient safety and facilitates market access in India’s growing healthcare sector, a key objective of CDSCO.

What Are the Different Risk Classifications for Medical Device Registration Types in India?

  • CDSCO classifies devices into four risk categories, detailed in the Medical Devices Rules, 2017 available on the CDSCO website:
    • Class A: Low risk (e.g., bandages, tongue depressors) with minimal oversight, as per CDSCO classification.
    • Class B: Low-to-moderate risk (e.g., hypodermic needles) requiring basic quality checks, according to CDSCO guidelines.
    • Class C: Moderate-to-high risk (e.g., ventilators) needing clinical data, as mandated by CDSCO regulations.
    • Class D: High risk (e.g., heart valves) subject to rigorous evaluation by CDSCO.
  • Classification determines the regulatory pathway and scrutiny level, as outlined by CDSCO.

What Licenses Are Required for Medical Devices in India?

How Does the Registration Process Work for Each Type?

  • Managed through the SUGAM portal, as directed by CDSCO.
  • Non-Notified (Class A/B):
    • Voluntary registration, as per the Medical Devices Rules.
    • Requires basic documentation (e.g., ISO 13485 certification), as specified by CDSCO.
    • Timeline: 3-6 months, according to CDSCO processing times.
  • Notified (Class C/D):
    • Mandatory registration, as per CDSCO regulations.
    • Requires technical dossiers, clinical data, and reference country approvals (e.g., FDA, CE), as detailed by CDSCO.
    • Timeline: 6-12 months, according to CDSCO processing timelines.
  • IVD Devices:
    • Similar to Notified devices, as per CDSCO IVD guidelines.
    • Additional performance studies for Class C/D to validate diagnostic accuracy, as required by CDSCO.
  • Higher-risk devices undergo stricter evaluation by CDSCO.

How Do Requirements Differ for Manufacturers vs. Importers?

  • Requirements tailored by CDSCO based on your role, as per the Medical Devices Rules:
    • Domestic Manufacturers:
      • Need manufacturing licenses (e.g., Form MD-3/5/7/9), as per CDSCO licensing.
      • Facility details, as required by CDSCO.
      • ISO 13485 certification, as mandated by CDSCO.
      • Audits by CDSCO.
    • Importers:
      • Require import licenses (e.g., Form MD-14/15), according to CDSCO import regulations.
      • Free Sale Certificates, as required by CDSCO.
      • Approvals from reference countries (e.g., FDA, CE), as per CDSCO guidelines.
  • Importers can leverage global approvals; manufacturers face local audits by CDSCO.

Which Application Forms Are Needed for Registration?

  • Specific forms for each registration type (available on the CDSCO website):
    • MD-3/MD-5: Application and issuance for Class A/B manufacturing, as per CDSCO forms.
    • MD-7/MD-9: Application and issuance for Class C/D manufacturing, according to CDSCO forms.
    • MD-14/MD-15: Application and issuance for import licenses, as per CDSCO forms.
    • MD-12/MD-13: Application and issuance for test licenses, according to CDSCO forms.
  • Submit via the SUGAM portal for streamlined processing with CDSCO.

What’s the Process for New Devices Without Predicates?

  • Unique process under the Medical Devices Rules, 2017 as detailed by CDSCO:
    • Clinical Trials: Comprehensive studies for safety and efficacy, as required by CDSCO.
    • Technical Dossier: Design, risk analysis, and performance data, as specified by CDSCO.
    • Timeline: Typically 12+ months due to extensive evaluation by CDSCO.
  • Requires robust evidence unlike predicate-based registrations, as emphasized by CDSCO.

How Do You Register a Testing Laboratory?

  • Labs must meet CDSCO standards:
    • ISO 17025 Accreditation: For testing competence, as per CDSCO guidelines.
    • Application: Submit infrastructure, equipment, and personnel details via the SUGAM portal to CDSCO.
    • Quality Systems: Documented testing procedures, as required by CDSCO.
    • Audits: CDSCO inspections for compliance.
  • Registered labs ensure device safety and performance standards mandated by CDSCO.

What Are the Types of Medical Device Groupings?

  • CDSCO allows grouping for registration, per the Medical Devices Rules available on the CDSCO website:
    • Single: One device (e.g., a catheter), as defined by CDSCO.
    • Family: Similar devices with varying sizes (e.g., stents), according to CDSCO guidelines.
    • System: Components working together (e.g., dialysis systems), as per CDSCO classification.
    • Group: Devices used in a single procedure (e.g., surgical kits), as defined by CDSCO.
  • Simplifies registration for related products under CDSCO regulations.

How Does IVD Registration Differ From Other Types?

  • Mirrors other medical devices but emphasizes diagnostics, per CDSCO’s IVD guidelines:
    • Performance Evaluation: Data on sensitivity, specificity, and reproducibility, as required by CDSCO.
    • Clinical Validation: Required for Class C/D IVDs to confirm accuracy, as per CDSCO standards.
    • Licensing: Use forms like MD-3/5/7/9 (manufacturing) or MD-14/15 (import) via the SUGAM portal with CDSCO.
    • Timeline: 3-6 months (non-notified), 6-12 months (notified), as per CDSCO processing times.
  • Ensures reliable diagnostic outcomes, a priority for CDSCO.

What Are the Post-Market Requirements?

  • Mandatory post-market compliance, as detailed in the regulatory guidelines on the CDSCO website:
    • Adverse Event Reporting: Report incidents or malfunctions to CDSCO.
    • Post-Market Surveillance: Monitor device performance as required by CDSCO.
    • License Renewal: Every 5 years with CDSCO.
    • Audits: Periodic inspections by CDSCO.
  • Maintains safety across all registration types, a core function of CDSCO.

Is Voluntary Registration an Option?

  • Yes, for Non-Notified devices (Class A/B), per the Medical Devices Rules on CDSCO:
    • Process: Submit device details and ISO 13485 certification via the SUGAM portal to CDSCO.
    • Benefits: Boosts trust and traceability with CDSCO.
    • Non-Mandatory: Optional for low-risk devices, as per CDSCO regulations.
  • Enhances market credibility with CDSCO.

How Long Are Registration Licenses Valid?

What Are the Registration Fees?

  • Fees vary by license type (check the CDSCO website for the latest):
    • CDSCO Manufacturing License Fees: ₹1,000 (Class A/B), ₹50,000 (Class C/D), as per CDSCO fee structure.
    • CDSCO Import License: ₹1,000 (Class A/B), ₹50,000 (Class C/D), according to CDSCO import license fee schedule.
    • Test License: ~₹10,000, as per CDSCO fees.
    • Inspections: Additional costs may apply, as per CDSCO policy.

What Challenges Might You Face During Registration?

  • Common challenges, per CDSCO insights:
    • Documentation: Extensive dossiers for Class C/D and IVDs, as required by CDSCO.
    • Language Barriers: Non-English documents need translation for CDSCO.
    • Timelines: 6-12 months for Notified devices, as per CDSCO processing times.
    • Regulatory Updates: Rules evolve, requiring vigilance regarding CDSCO notifications.
  • Regulatory experts can help overcome these hurdles with CDSCO.

Where Can You Find Official Information?

  • Official resources:
    • CDSCO Website: Guidelines, forms, and updates from CDSCO.
    • SUGAM Portal: Application submission and tracking with CDSCO.
    • Notifications (on the CDSCO website).
    • CDSCO Offices: Direct support for queries from CDSCO.

Conclusion: Mastering CDSCO for Market Success

  • Navigating Non-Notified, Notified, and IVD registration is crucial for India’s $50 billion market, guided by CDSCO.
  • Understanding risk classifications and post-market duties is key to compliance with CDSCO regulations.
  • Visit the CDSCO website, prepare diligently, and consider expert support to ensure compliance and market readiness with [CDSCO]