How to Register Medical Devices in India
A Step-by-Step Guide for MedTech Manufacturers
Are you an overseas medical device manufacturer planning to enter the Indian healthcare market? You’re not alone—India is among the fastest-growing markets worth $638 billion in 2025 for medical devices globally. Before manufacturers start shipping products or signing up distributors, you’ll need to navigate India’s regulatory landscape, which can feel complex and mastering India’s regulatory framework positions you to confidently launch products & secure partnerships.
Here’s a complete guide to Central Drugs Standard Control Organization (CDSCO) medical device registration—for appointing an Indian Authorised Agent to securing import licenses and ensuring compliance under the Indian Medical Device Rules (MDR), 2017.
Step 1: Appoint an Indian Authorized Agent (IAA)
All foreign medical device manufacturer based outside of India, must appoint an Indian Authorised Agent (IAA). IAA is a legal entity that represents you in front of the CDSCO and must be a registered legal entity in India, as below:
- A Private Limited Company
- An LLP or Proprietorship
- Your own subsidiary (if applicable)
Key critical roles played by IAA as per the Indian Medical Device Rules (MDR), 2017 are:
Can distributors serve as your IAA? Yes, provided they meet CDSCO requirements. However, Independent IAA represents manufacturer’s interest with unbiased regulatory oversight and localized market expertise.
Step 2: Understanding Device Classification in India
India follows a risk-based classification system aligned with global practices. Devices are categorized into four classes:
| Class | Risk Level | Examples | Licensing Authority | Regulatory Pathway |
|---|---|---|---|---|
| A | Low Risk | Surgical dressings, thermometers | Central Licensing Authority | Online Registration Only via SUGAM Portal |
| B | Low to Moderate | Hypodermic needles, suction equipment | Central Licensing Authority | |
| C | Moderate to High | Bone plates, orthopaedic implants | Central Licensing Authority |
CDSCO Import License (MD-14/ MD-15) |
| D | High Risk | Pacemakers, heart valves | Central Licensing Authority |
CDSCO’s official website provides a list of regulated medical devices, their classifications, and publishes all approved products for public access. The product classification determines the documentation, review process, and the required regulatory pathway.
Step 3: Registration on the CDSCO OSMD Portal
All applications must be submitted by the IAA through the CDSCO Online System for Medical Devices (OSMD) and complete the Applicant Registration Form on the portal with uploading digitally signed documents in the suggested format.
Step 4: Determining the Regulatory Pathway and Application Submission
Under the Indian Medical Device Rules (MDR), 2017, the following are the available regulatory pathways, required application forms, and licenses issued by the CDSCO.
Overview of Import Regulatory Pathways for Medical Devices under MDR 2017
| Device Category | Description | Application Form(s) | License/Approval Issued |
|---|---|---|---|
| Approved Medical Devices | Devices with a predicate or similar product approved by CDSCO | Form MD-14 | Form MD-15 (Import License) |
| New Medical Devices | Devices without an approved predicate in India, requiring prior permission and often clinical investigations. | Form MD-26 → MD-14 | MD-27 (Permission) + MD-15 |
| New In Vitro Diagnostic Devices | No predicate IVD; requires performance evaluation or studies | Form MD-28 → MD-14 | MD-29 (Permission) + MD-15 |
Core Documentation Checklist for Import License (MD-15)
Step 5: Application Approval and License Grant
Post submission, CDSCO will evaluate the documents, and may raise queries or request additional data from the IAA and manufacturer which is required to be submitted in a stipulated timeframe. On certain high-risk devices (class C and D), inspections of the manufacturing site may be applicable.
Upon satisfactory review, the import license is issued in Form MD-15 valid for a five-year period subject to renewals and is essential for customs clearance & legal import of the device in India.
Ready to Enter the Indian Medical Device Market?
RegTrac is your trusted global regulatory partner with expertise on both global medical device regulations and India-specific CDSCO requirements. RegTrac’s speed to market approach with independent AR Solutions for IAA in India, ensures streamlined regulatory compliance including liaison with health authorities with onsite CDSCO support and on-time market approvals. Schedule a call today with our technical expert and sales partner to begin your compliance journey!
RegTrac is here to help you go from “interested in India” to import-ready and compliant! Talk to us today!
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