Medical Device Approval Process in India

India’s medical device market, projected to reach $370 billion by 2025, is a dynamic and rapidly growing sector regulated by the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare. The Medical Devices Rules, 2017, effective from January 1, 2018, and amended in 2020, govern the import, manufacture, sale, and distribution of medical devices under the Drugs and Cosmetics Act, 1940. This guide outlines the step-by-step process for obtaining approval to market medical devices in India, including classification, requirements, timelines, and key considerations.

Overview of Regulatory Framework

The CDSCO, led by the Drug Controller General of India (DCGI), is the primary regulatory authority responsible for ensuring the safety, efficacy, and quality of medical devices. The Medical Devices Rules, 2017 introduced a risk-based classification system, streamlined registration processes, and aligned India’s regulations with global standards, such as those of the International Medical Device Regulators Forum (IMDRF), of which India became a member in 2023. Since April 2020, all medical devices are classified as “drugs” under the Medical Devices (Amendment) Rules, 2020, requiring mandatory registration or licensing.

Medical Device Classification

Medical devices in India are classified into five categories based on risk, as outlined in the Medical Devices Rules, 2017:

Class	Risk Level	Examples
A (Non-Measuring/Sterile)	Low	Non-sterile bandages, surgical dressings
A (Measuring/Sterile)	Low	Sterile syringes, thermometers
B	Low-Medium	Spinal needles, tracheostomy tubes
C	Medium-High	Dental implants, catheters, stents
D	High	Heart valves, cochlear implants, orthopedic implants

• Class A (non-measuring/non-sterile) devices are the least regulated, requiring only registration via the CDSCO’s online portal.
• Class A (measuring/sterile), B, C, and D devices require an Import License (Form MD-15) for importation, with increasing scrutiny based on risk.

As of October 1, 2023, all Class A (measuring/sterile), B, C, and D devices must possess an MD-14/15 Import License for importation. Approximately 40–50 device “families” (e.g., syringes, stents, heart valves) are currently notified for mandatory registration, with the list expanding periodically. Non-notified devices may require a No Objection Certificate (NOC) from the DCGI for import.

Step-by-Step Approval Process

The approval process for medical devices in India varies by classification and whether the device has a predicate device (a substantially equivalent device already approved in India). Foreign manufacturers must appoint an Authorized Indian Representative (AIR) to act as a liaison with the CDSCO. Below is the detailed process:

Step 1: Appoint an Authorized Indian Representative (AIR)

• Foreign manufacturers must designate a local entity (subsidiary, agent, or distributor) with a valid wholesale license (Form 20-B/21-B) as their AIR.
• The AIR handles regulatory submissions, compliance, vigilance, and adverse event reporting on behalf of the manufacturer. Multiple distributors can be appointed without separate registrations, as the AIR holds the license.

Step 2: Classify the Device

• Determine the device’s risk class (A, B, C, or D) based on its intended use, material, and design, as per the Medical Devices Rules, 2017.
• Check if the device is on the CDSCO’s list of notified devices or requires an NOC. A regulatory consultant can assist in accurate classification.

Step 3: Prepare the Regulatory Dossier

• Compile a comprehensive Device Master File (DMF) and Plant Master File (PMF) for each manufacturing site. Required documents include:
  • ISO 13485 Certificate: Verifying quality management system compliance.
  • Free Sale Certificate (FSC) or Certificate of Marketability: From GHTF countries (U.S., EU, Canada, Australia, Japan, or UK).
  • Declaration of Conformity: Confirming compliance with standards.
  • Technical Dossier: Including device description, intended use, material of construction, instructions for use (IFU), and testing results.
  • Clinical Data: For Class B, C, and D devices, if no predicate exists, or for investigational devices.
  • Proof of Approval: In the home country and GHTF countries to streamline requirements.
  • Labeling: Compliant with Medical Devices Rules, 2017, including manufacturer details, batch number, and expiry date.
• All documents must be in English and notarized. If a Quality Manual per ISO 13485 includes PMF content, it may suffice.

Step 4: Submit Application via SUGAM Portal

• File an application using Form MD-14 (for Class A/B) or Form MD-15 (for Class C/D) through the CDSCO’s SUGAM online portal.
• Pay applicable fees, which vary by device class and manufacturing site:
  • Manufacturing Site: $0–$300.
  • Device Family: $0 (Class A) to $4,500 (Class D).
• For devices without a predicate, submit Form MD-26 for clinical investigation approval, which may involve review by the Subject Expert Committee (SEC) or Medical Device Advisory Committee (MDAC).

Step 5: CDSCO Review

• The CDSCO reviews the application for completeness and compliance, typically within 45–90 days.
• Queries may be raised, requiring the AIR to respond promptly. Approximately 25% of applications require a Technical Presentation, an in-person meeting with CDSCO officials, attended by the AIR and a manufacturer representative (e.g., an engineer).
• For Class C/D devices or those without predicates, a detailed technical review may involve consultations with the Technical Advisory Committee (TAC) or SEC, extending the timeline.

Step 6: Clinical Investigation (If Required)

• Class B, C, and D devices without predicates or investigational devices require clinical investigations in India to establish safety and efficacy.
• Submit a Clinical Investigation Plan (CIP) via Form MD-22 on the SUGAM portal. Approval is granted in Form MD-23.
• Investigations must adhere to Good Clinical Practice (GCP) and the Declaration of Helsinki for ethical standards. Foreign clinical data may be accepted if from GHTF countries.

Step 7: Issuance of Import License

• Upon approval, the CDSCO issues an Import License (Form MD-15) for each manufacturing site, listing approved devices. The license is valid for five years, with renewal requiring updated DMFs/PMFs and fees.
• Class A (non-measuring/non-sterile) devices are registered instantly via the SUGAM portal ePortal and can be imported immediately.

Step 8: Post-Market Surveillance

• Manufacturers and AIRs must comply with the Materiovigilance Program of India (MvPI) for monitoring adverse events and device malfunctions.
• Submit Periodic Safety Update Reports (PSURs) to ensure ongoing safety. Since its launch, MvPI has led to the recall of 16 medical devices.

Timelines

• Class A (non-measuring/non-sterile): Immediate registration via ePortal.
• Class A (measuring/sterile), B, C, D: 6–9 months for standard approval if no clinical trials or SEC review is required.
• With Technical Presentation/SEC Review: Additional 3–6 months.
• With Clinical Investigation: 9–18 months, depending on complexity and trial requirements.
• Query Response: CDSCO pauses the review clock until queries are addressed, typically within 45–90 days.

Key Considerations

1. Predicate Devices:
   • Devices with a substantially equivalent predicate (similar intended use, material, and design) approved in India face fewer requirements. Non-predicate or “new” devices require MDAC/SEC review and clinical investigations.
2. Global Approvals:
   • Prior approval in GHTF countries (U.S., EU, Canada, Australia, Japan, UK) can streamline the process by leveraging existing documentation and reducing clinical trial needs.
3. Labeling and Compliance:
   • Devices must meet Bureau of Indian Standards (BIS) and Medical Devices Rules, 2017 labeling requirements. India-specific labels (e.g., importer details, license number) can be added post-import at customs warehouses.
4. Make in India Initiative:
   • The government encourages local manufacturing through price controls (e.g., on stents and knee implants) and the National Medical Devices Policy, 2023, which promotes domestic production and innovation.
5. Challenges:
   • Frequent regulatory updates can create uncertainty.
   • Query response times and SEC reviews may delay approvals.
   • Non-notified devices require NOCs, adding complexity.

Special Cases

• Investigational Devices: Small quantities of Class A–D devices approved in their country of origin can be imported for treatment of life-threatening conditions via Form MD-18, applied by a government hospital or medical institution.
• Test Licenses: Importers/manufacturers can obtain a Test License (Form MD-17) for small quantities of devices for testing, evaluation, or training.
• Changes to Approved Devices: Modifications to indications or intended use require a revised Power of Attorney and CDSCO approval via change notification.

Expert Support

Navigating the CDSCO approval process can be complex due to documentation, query responses, and evolving regulations. Engaging consultants like Emergo by UL, Morulaa, CliniExperts, or Corpbiz can streamline compliance, classification, and submission. These firms offer services such as:

• Device classification and predicate identification.
• Dossier preparation and SUGAM portal submissions.
• AIR representation and query resolution.
• Post-market vigilance support.

Conclusion

The medical device approval process in India, governed by the CDSCO under the Medical Devices Rules, 2017, is a structured yet evolving framework designed to ensure safety and efficacy while fostering market access. By understanding classification, preparing comprehensive documentation, and leveraging global approvals, manufacturers can navigate the process efficiently. With India’s healthcare industry poised for significant growth, compliance with CDSCO regulations offers a gateway to one of the world’s most promising medical device markets. For detailed guidance, consult the CDSCO website or engage a regulatory expert to ensure timely and successful market entry.