Currently, the Indian medical device and pharmaceutical market is largely unregulated and medical devices can be freely imported into the country. The Ministry of Health and Family Welfare and the Central Drugs Standard Control Organization (CDSCO) are the two regulatory bodies that are responsible for overseeing medical devices within India. The CDSCO is divided into 6 zone offices, 4 sub-zonal offices, 13 port offices, and 7 laboratories.
The CDSCO exercises regulatory control over the import of medical devices and approves new medical devices and clinical trials. The CDSCO also oversees the Central Licensing Approving Authority (CLAA), the body responsible for ensuring medical device compliance. Under India medical device regulations, only certain medical devices require pre-market review, while other products that are typically regarded as devices are instead classified as drugs.
Foreign device manufacturers should submit evidence of regulatory approval in the country of origin before receiving regulatory authorization within India.
Drugs and Cosmetics Act
Medical devices are regulated under the Drugs and Cosmetics Act. Under the Drugs and Cosmetics Act, the regulation of the manufacturing, sale, and distribution of drugs and devices is primarily the concern of state authorities. Central authorities are responsible for approving new drugs and medical devices, controlling the quality of imported drugs, coordinating the activities of state organizations, and providing expert advice in order to bring about a uniformity in enforcement of the Drugs and Cosmetics Act.
In 2015, the Ministry of Health and Family Welfare released a draft report that detailed changes to the Drugs and Cosmetics Act. While the draft has yet to be approved by India’s Parliament, the publicly available report calls for a number of changes to India’s medical device regulatory system. The most important changes include:
- Updating the definition of certain medical devices and in vitro diagnostics
- Clearly defining and systematizing device import requirements
- Clarifying existing regulatory requirements for medical devices
- Establishing a Medical Devices Technical Advisory Board
- Updating India’s Good Manufacturing Practices so that they more clearly match ISO 13485
- Improving submission of clinical drug applications and implementing an online system
These changes could significantly alter the medical device approval and registration process.
For more detailed information regarding the requirements and process for registering medical devices in India, please see Medical Device Registration in India.
India Medical Device Regulatory Resources
India Medical Device Regulatory Webcast
The India Medical Device Regulatory Update Webcast provides expert insight into the regulatory pathway for India’s medical device market, covering which types of medical devices must be registered under the latest regulations; new requirements for product registration, labeling, and pricing; best strategies for device renewal; and more. Challenges in the registration process will be highlighted in this informative webcast.
Medical Device Regulatory News from India
Pacific Bridge Medical releases timely news briefs on medical device regulatory affairs in Asia every month. Click here to view the latest updates on India medical device regulations.