Understanding the Regulatory Evolution of Medical Devices in India
Earlier, manufacturers could sell medical devices in India without any jurisdictions. Since 2006, medical devices entering India must be in compliance with the Medical Device India 2017 Regulations set forth by the CDSCO. The CDSCO is responsible for approval and regulation of New Drugs and Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
Below is a step by step process for registering your medical device in India.
Step 1 – How to Identify If Your Medical Device Needs Registration in India
In India, the import, manufacturing, sale, and distribution of medical devices are governed by the Medical Devices Rules, 2017, under the Drugs and Cosmetics Act, 1940. Previously before 2018, 37 categories of Notified medical devices were regulated. Now all Medical devices must be registered before sales in India. Devices requiring Medical Device Registration India include spinal needles, cochlear implants, annuloplasty rings, tracheostomy tubes, syringes, dental implants, surgical sealants, heart valves, stents, orthopedic implants, catheters etc. The process to register in India involves various steps outlined in this guide. Registration with CDSCO involves submitting documents like technical dossiers and clinical data. The Step by Step process to register in India can take 6 to 9 months, though CDSCO may grant an exemption via a No Objection Certificate (NOC), typically within 4 to 12 weeks, depending on the device’s complexity and regulatory status.
Step 2 – Appointing an Authorized Indian Representative for CDSCO Compliance
In India, foreign manufacturers must appoint an Authorized Indian Representative (AIR) who acts as their point of contact for regulatory authorities. The AIR assists with device approval, registration, and compliance, including vigilance and adverse event reporting. This representative must be registered with the CDSCO and hold a valid wholesale license in Forms 20B and 21B.
The foreign manufacturer, as the registration certificate holder for Medical Device Registration India, can freely appoint multiple distributors in India. The Authorized Indian Representative (AIR) serves as a liaison with CDSCO, ensuring regulatory compliance and streamlining the approval process to register in India , with no need for separate registrations for each distributor.
Step 3 – Submit the Regulatory Dossier under Form MD-14/MD-15
To initiate the process of Medical Device Registration India, a regulatory dossier must be prepared with the following required documents:
- Form MD-14/MD-15
- TR6 Challan
- Power of Attorney
- Schedule D(I)
- ISO 13485 Certificate
- CE Design Certificate (or other equivalent certifications)
- Declaration of Conformity
- Free Sale Certificate
- Certificate of Marketability from countries with stringent regulatory approval (e.g., GHTF countries)
- Other Regulatory Approvals
- PMS (Post-Market Surveillance) Report
- Plant Master File
- Device Master File
The CDSCO fees for registering a single manufacturing site varies from US $0 to US $300, and for a single device family, it is from US $0 to US $1500. This depends on the class of the medical device and the government fee per class can be found on Our Blog. The overall Step by Step process to register in India typically takes between 6 to 9 months.
During the process to register in India if the product does not have a predicate device in India, the registration process will require additional steps. In such cases, manufacturers must submit Form MD-26 for clinical investigation approval. Furthermore, the product will be reviewed by the Subject Expert Committee (SEC), a special committee appointed by the CDSCO to evaluate the product’s safety and efficacy for the Indian market. This may extend the approval timeline depending on the complexity of the device.
Step 4 – Obtain Registration Certificate in Form MD-15
After the document submission the CDSCO typically responds to the Authorized Indian Representative (AIR) with queries within 45 to 90 days. After addressing the queries, The CDSCO may issue more queries or grant the Medical Device India registration certificate in Form MD-15, valid for five years. The timeline depends on the device complexity and response time.
Step 5 – How to Secure an Import License for Medical Devices in India
As a part of Medical Device Registration India the distributor or Authorized Indian Representative (AIR) applies for the import license with CDSCO by submitting Form MD-14 along with Form MD-15, which references the registration certificate number. This process typically takes 4 to 12 weeks for approval. The import license allows the registered device to be imported into India.
Step 6 – Guidelines for Marketing Medical Devices in India After Registration
After obtaining the registration certificate and import license,the Medical Device Registration India is complete, allowing the product to officially enter the Indian market. The Authorized Indian Representative (AIR) must report any changes, adverse events, recalls, or regulatory actions from other countries to CDSCO promptly. Ongoing compliance with post-market surveillance requirements is essential to maintain regulatory approval.
For more information, contact our team of experts.