- Changing the Regulations for Class A Medical Devices and its Impact - September 27, 2022
Last Updated on February 6, 2023 by The Health Master
The Govt. of India issued a draft notification GSR 710(E) on September 20th, 2022, and gave just 7 days’ time to the industry to respond, thus making it clear to the stakeholders that this will be soon finalized without much change to its shape and size.
I would like to draw the attention of the medical devices industry to some of the points that the industry and the authorities must ponder about the impact these changed regulations will have on the market.
This draft notification is issued almost at the fag end of the expiry of mandatory registration as per GSR 102(E) dated February 11, 2020, and the effective date is October 1, 2022.
The license will be applicable and many of the medical device manufacturers and importers have already submitted the applications after paying the due fee as per the Second Schedule of GSR 78(E) dated January 31, 2017.
Out of these many medical devices, manufacturers have already been audited by the Central Drugs Standard Control Organisation (CDSCO) approved notified bodies after paying the fee as prescribed by the CDSCO for the audit.
And many have already been issued the licenses by the State Licensing Authorities.
So what is going to be for them as they have already shelled out the money for them?
Many medical device companies may feel cheated as they have done the complete exercise, followed all the compliances, and have either received their approval or are just due to receive it in a few days.
This is the same as students who studied well throughout the year and were ready for their final exams, and all of a sudden the examinations were scrapped and all declared passed.
The students, who didn’t touch their books for the complete year, also got the same passing marks as it’s for the whole of the Class.
This notification GSR 710(E) is probably to help the people who were sleeping to date and were not abiding by the regulations introduced by this CDSCO office, which were in line with many developing and developed countries in the world to have regulations in place to improve public health by avoiding sub-standard medical devices in the market.
As we all know that there are many medical devices available in the Indian market manufactured by unsolicited manufacturers running their show from a single shabby room in many areas unfit for even living and these medical device land in many hospitals easily as they save on cost but not on human lives.
So, we must ask a question ourselves, Why aren’t we compromising on human health and pushing the public at large to a substandard medical device?
One technical point to be brought to the notice of all is that the registration number issued by the CDSCO portal has been creating a lot of confusion in the market because of a lack of awareness.
As many of the hospitals used to demand either Form MD-15 for imported items and MD-05 or MD-06 or MD-09 or MD-10 for a domestically manufactured non-regulated medical device wherein either a registration no. issued by the CDSCO was either available or just a Screenshot of submission of registration under MDR 2020 under GSR 102(E).
This became very difficult for the medical device manufacturers/importers to explain to the Hospitals/Tendering Authorities about the non-availability of issuance of any certificate or any letter/mail from authorities for such registrations.
This would request the authorities to kindly maintain a uniform system of issuing licenses to all medical devices across the board.
In my opinion, these changed regulations may help the industry towards a short-term gain, but this will result in a long-term loss to the health of the medical device industry and humans.
I request the readers to do some introspection and turn the tables toward the proper regulations to have a healthy environment and a level playing field in the global market.
By: Dr. B. N. Nagpal
The author is CEO at M N Solutions, Medical Device Regulatory Consulting. Email: email@example.com
DISCLAIMER: The views expressed are solely of the author and TheHealthMaster.com does not necessarily subscribe to it. TheHealthMaster.com shall not be responsible for any damage caused to any person / organization directly or indirectly.
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