India’s healthcare sector is growing at a rapid pace, and with the increasing demand for advanced medical technologies, the import and distribution of medical devices have become more prominent than ever. However, to ensure safety, efficacy, and regulatory compliance, the Indian government has laid down a structured framework for the import of medical devices. As of 2025, any company planning to enter the Indian medical device market must follow updated rules governed by the Central Drugs Standard Control Organization (CDSCO). Here's a comprehensive look at the essential documentation required for a smooth import and distribution process.
1. Import License (Form MD-15)
Any medical device that is regulated under the Medical Devices Rules, 2017 must have an import license. The license is issued in Form MD-15 under the Medical Devices Rules, 2017, and is mandatory for Class A, B, C, and D devices. The applicant must submit an application through the CDSCO’s online SUGAM portal along with the required documents and prescribed fees.
2. Free Sale Certificate (FSC)
An FSC from the country of origin is a vital document. It confirms that the medical device is freely sold in the manufacturing country. This is crucial for CDSCO to assess the legitimacy and safety track record of the product.
3. Device Master File (DMF) and Plant Master File (PMF)
These technical files are required to provide in-depth information about the design, manufacturing process, safety features, and quality control systems used. These documents help CDSCO evaluate the risk classification and technical specifications of the medical device.
4. Power of Attorney (PoA)
If the manufacturer is not based in India, a Power of Attorney must be submitted appointing an Indian Authorised Representative (IAR) who will be responsible for all communications with the regulatory authority and for holding the import license on behalf of the foreign manufacturer.
5. Notarized and Apostilled Documents
Documents such as PoA, FSC, and others often require notarization and apostille to ensure they are legally valid for submission in India.
6. Registration with Indian Port Authorities
For actual import and clearance at Indian ports, importers must register with authorities like the Central Board of Indirect Taxes and Customs (CBIC) and obtain an IEC (Import Export Code) from the Directorate General of Foreign Trade (DGFT).
7. Labeling and Packaging Requirements
Imported medical devices must comply with Indian labeling regulations, which include the name and address of the importer, manufacturing date, expiry date, storage conditions, and MRP. Non-compliance may result in customs rejection or legal penalties.
Agile Regulatory: Your Trusted Compliance Partner
Navigating India’s regulatory framework can be overwhelming, especially for companies unfamiliar with local requirements. This is where Agile Regulatory steps in. With years of experience in CDSCO approvals, import licensing, and regulatory documentation, Agile Regulatory assists manufacturers and importers in obtaining the necessary approvals and licenses for seamless entry into the Indian medical device market. From handling documentation to liaising with authorities, Agile Regulatory ensures that your products are compliant and market-ready—saving time, reducing risks, and accelerating your go-to-market strategy.
Conclusion :
Importing medical devices into India involves meticulous planning and adherence to strict regulatory norms. With proper documentation, due diligence, and expert guidance, manufacturers can unlock immense potential in India’s expanding healthcare landscape. Partnering with a regulatory expert like Agile Regulatory can make all the difference in achieving timely approvals and sustainable market access.