Summary: The process of medical equipment registration in India is quite different compared to drug product registration. Extending the deadline for this switch will give the manufacturers ample time to adjust their procedures and shelve-off their existing products in the market.
Last year the Ministry of Health & Family Welfare published a notification in the Gazette of India, Part II, Section 3, Sub-section (ii) vide number S.O. 775(E), dated the 8th February, 2019. According to this notification, several medical devices along with implantable medical devices were classified as drugs under the Drugs & Cosmetics Act, 1940.
The medical diagnostic equipment we’ll be talking about in this article include:
- CT scan Equipment
- MRI Equipment
- Dialysis Machine
- PET Equipment
- X-Ray Machine
- Bone marrow cell separator
An amendment to this notification was made recently according to which, the effective date for the implementation of the principal notification was changed from 1st day of April 2020 to 1st day of April 2021.
Why was this amendment made and what are the implications of this notification
The amendment was made in this notification to relieve the stakeholders amidst confusion in the definition and classification of medical devices. Moreover, the immediate implementation of this rule might create ruckus or unrest among the manufacturers and the market.
These new regulations have been welcomed by the Indian manufacturers of medical devices. Since the medical device market in India is highly unregulated, the quality of such products is always at stake. Furthermore, a majority of high risk medical device market is covered by foreign imported medical devices.
This new step taken by the government will regulate the medical device market in a better way, and will improve the quality of products being delivered to the Indian consumers.
Additionally, the process of the registration and approval of drugs is highly regulated and precise. Including medical devices in the purview of drugs will result in dedicated testing and will improve their credibility in the local as well as global market.
As a matter of fact, India is the fourth largest medical device market in the world. With a developing economy and highly skilled workforce, the improving quality of the medical devices can be a financial benefactor for the country in the long run.