Medical Device Registration in India
The Indian medical regulatory system has become more complicated in recent years. In the past, medical devices did not need to be approved at all, but that is not the case today. In India, there are about 30 device “families” that outline which specific medical devices need to be registered.
With the rising opportunities in India comes increasing regulations that companies must face and overcome. With the assistance of a highly experienced third-party regulatory compliance consultant such as Pacific Bridge Medical, the registration process is much less complex.
WHICH REGULATORY BODIES IN THE INDIAN GOVERNMENT ARE RESPONSIBLE FOR MEDICAL DEVICES REGISTRATION?
- The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for pharmaceuticals and medical devices.
- The Drug Controller General of India (DCGI) is the key official within the CDSCO. The DCGI is responsible for the approval of the manufacturing of certain drugs (vaccines, large volume parenterals, blood products, r-DNA derived), specific medical devices, and new drugs.
- In India, the manufacturing, import, sale, and distribution of medical devices are regulated under India’s Drugs & Cosmetic Act and Rules (DCA).
WHAT ARE DIFFERENT REGULATORY CLASSIFICATIONS FOR MEDICAL DEVICES?
Currently there is not a formal regulatory classification scheme, however, draft regulations outline the following:
- Class A – Low Risk (example: thermometers, tongue depressors)
- Class B – Low-moderate Risk (example: hypodermic needles, suction equipment)
- Class C – Moderate-high risk (example: lung ventilator, bone fixation)
- Class D – High Risk (example: heart valves, implantable devices)
WHAT DOES REGISTRATION PATHWAY LOOK LIKE FOR REGULATED MEDICAL DEVICES?
(Non-Regulated Medical Devices with a NOC are exempt from registration)
- Companies must register regulated medical devices with the DCGI before they can be introduced into the Indian market.
- For new medical devices, prior approval from the DCGI must be obtained before the device can apply for registration.
- Upon receipt of the application with fees, evaluation begins.
- The DCGI may require clinical testing in India or abroad.
- The DCGI may visit the manufacturing premises during the process.
Summary of Steps for the Medical Device Registration Process in India
- Appoint a local agent in India to be the applicant and license holder
- Prepare Device Master File (DMF)
- Prepare Plant Master File (PMF)
- Prepare application Form w/supporting documents
- Submit above documents to DCGI with fees
- DCGI reviews and sends back an inquiry letter
- Applicant responds and addresses inquiries made by the DCGI
- DCGI may request technical presentation
ARE MEDICAL DEVICES REQUIRED TO BE REGISTERED BEFORE THEY CAN BE SOLD?
Currently only 40-50 medical devices require registration. For all other medical devices that do not require registration, the manufacturer should obtain a No Objection Certificate (NOC) from the DCGI. The NOC is a letter from the DCGI stating that the product does not require registration and can be imported freely into India.