To strengthen the regulations of medical devices in India, the Central Drugs Standard Control Organization (CDSCO) has released two final amendments to the Medical Device Rule 2017. The amendments are expected to provide more clarity on the scope of medical devices and establish an expedited registration route for certain devices. The CDSCO has announced that both the amendments will come into effect from April 1, 2020. But how exactly will they impact the Indian medical device Regulatory scenario? Let’s take a look.
As per the first amendment, the CDSCO has expanded the definition of “Medical Device” in its regulations. The new definition of medical devices is more aligned with that of the Global Harmonization Task Force (GHTF). The purpose of revising the definition was to increase the scope of medical devices that needs to be registered in India.
On February 11, 2020, the CDSCO added “Chapter: IIIA – Registration of Medical Devices” to the existing Medical Device Rule 2017. The chapter was introduced to regulate certain medical devices that were not regulated under the Rule earlier. It provides a new route of registration to applicable manufacturers, wherein they can provide the required documentation and certifications for Regulatory review via an online portal. Furthermore, devices entering the Indian market by this route will be exempted from other requirements of the Medical Device Rule 2017.
While registering the manufacturers will be required to submit some information to the health authority, such as manufacturer details, product details, Certificate of Free Sale (FSC) and ISO information. Once the submission is complete, the manufacturer will be provided with a registration number, which can be used on the label for marketing purposes.
Voluntary Period and Timelines
The CDSCO has also provided a voluntary period of 18 months from the date of implementation of Chapter IIIA to the manufacturers. Post the implementation date, the amendment will become mandatory for all the medical device manufacturers. The Regulatory requirements of the amendments will be applicable to the medical devices as follows:
- Class A and Class B – 30 months post the implementation date
- Class C and Class D – 42 months post the implementation date
Currently, majority of the domestic medical devices are not registered with the CDSCO. Once these amendments come into force, it will become mandatory for all the manufacturers to register their devices with the health authority. For successful registration and market-entry, it is advised that the manufacturers should consult a Regulatory expert with a strong presence in India. Register your devices during the voluntary period. Stay updated. Stay compliant.