Background
Earlier, manufacturers could sell medical devices in India without any jurisdictions. Since 2006, medical devices entering India must be in compliance with the Indian Medical Device 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 – Determine If Your Product Requires Registration
In India import, manufacturing, sale and distribution of Medical devices is regulated under Drugs and Cosmetics Act, 1940; and Rules, 1945. At present 22 Notified Medical Devices are regulated under the said Act. Medical devices which require registration in India include spinal needles, cochlear implants, annuloplasty rings, trachestomy tubes, syringes and needle, dental implants, surgical sealants, heart valves, cardiac stents, orthopedic implants, endotracheal tubes, and catheters, among others. These devices should undergo registration process with the CDSCO ( Documents required to register your medical device in India ). The list is not limited to these devices. In some cases the DCGI will review certain product information and provide an exemption on registration process of a medical device in the form of an NOC. This process takes anywhere between 4 to 12 weeks.
Step 2 – Appoint an Authorized Indian Agent
The regulations in India require that foreign manufacturers have a representative in India who will act on their behalf as the point of contact for inspection authorities, assist in device approvals and registration process and vigilance/adverse event reporting.
A manufacturer can appoint an authorized Indian agent to register with the CDSCO on their behalf. The Indian Agent will acts as a liaison between you and the CDSCO’s Medical Devices Division. The authorized Indian agent should have a wholesale drug license in from 20B and 21B. The manufacturer will be the holder of the registration certificate and freely appoint multiple distributors in the country.
Step 3 – Submit the Regulatory Dossier under Form 40
A dossier has to be prepared with the required list of documents to start the registration process. Below is an overview of the list of documents required,
- Form 40
- TR6 Challan
- Power of Attorney
- Schedule D(I)
- ISO 13485 Certificate
- Full Quality Assurance Certificate
- CE Design Certificate
- Declaration of Conformity
- Free Sale Certificate
- Certificate of Marketibility from GHTF countries
- Other Regulatory Approvals
- PMS report
- Plant Master File
- Device Master File
The CDSCO fees for registering a single manufacturing site is US $1500 and US $1000 for a single device family. The time for registration process can take anywhere between 6 to 9 months. If the products do not have a predicate in India the processing time will increase and special committee will be appointed to determine the products safety and efficacy for the India market.
Further details are specified in Document required for registering your medical devices in India and Things to keep in mind when preparing the dossier.
Step 4 – Obtain Registration Certificate in Form 41
After the document submission the CDSCO will get back to the Indian Agent with first query letter in about 3 months time. Upon receiving the answers for the query the CDSCO will either issue a subsequent query letter or grant license. The registration certificate is valid for 3 years.
Step 5 – Obtain Import License in Form 10
The Form-10 has to be applied at the CDSCO by distributor directly. An application has to be made in Form 8 along with Form 9 which mentions the registration certificate number. This process takes 4 to 12 weeks.
Step 6 – Marketing in India
Once the registration certificate and the import license are issued the product can enter the Indian market. The authorized Indian agent should report any change, adverse events, recalls in other countries etc to the CDSCO as and when they happen.
To learn more contact our team of experts.
