The new certification schemes are also justified as some experts also argue that new medical device (MD) rules 2017 will be implemented in a phased manner only until August 2023 as per government notifications.
As of today, Indian medical device companies are therefore unable to demonstrate product safety as there is neither licensing nor local certification framework available to the indigenous manufacturers in India.
Currently, 37 categories of medical devices are regulated which cover around 400 medical devices amongst the 5, 000 odd unregulated medical devices in the country which poses an alarming risk to patients in the country. The ICMED Plus certification is an option currently available to the Indian manufacturers to demonstrate compliance to new MD rules.
“These kinds of indigenous certifications will ensure that domestic manufacturers are not denied the opportunity to showcase compliance of their medical devices domestically and globally in the absence of international certifications from regulatory authorities like US FDA and MHRA,” according to experts.
A certain section of the industry advocates that the indigenous certifications will help Indian industry to remain competitive and prove their product authenticity and competitiveness in India vis- a- vis globally to achieve self-reliance. But other experts beg to differ saying that these additional certifications, which were not required in the first place, will enhance compliance burden among domestic players.
According to Anil Jauhri, former CEO, National Accreditation Board for Certification Bodies (NABCB), “Problem lies in implementation of medical device rules (MDR) -2017 earliest by October 2023. So till then there is no assurance of product quality.”
NABCB is accrediting certification and inspection bodies in India and its accreditation programmes are internationally equivalent placing it on par with European and American accreditation bodies. This equivalence helps facilitate acceptance of ICMED certification in the overseas market.
“As of today registration today requires only ISO 13485 certification for quality management systems (QMS) and not for product compliance. Therefore, there is a need for independent certification for product compliance of medical devices more so as registration does not provide assurance of product quality and safety. MNCs are opposing because they will lose the advantage of USFDA and CE approvals,” Jauhri added.
In order to enhance prospects of the Indian medical devices sector, the Quality Council of India (QCI), and the Association of Indian Manufacturers of Medical Devices (AiMeD) had jointly launched the ICMED Plus Scheme in June 2021. The scheme is meant to significantly eliminate the use of trading of sub-standard products or devices of doubtful origins.
ICMED Plus Scheme is also a competency building exercise to achieve harmonization with global medical device quality certifications. ICMED Plus Scheme has added further features to the ICMED, the Scheme that had been launched for Certification of Medical Devices in 2016.
“MD Rules prescribes compliance to product related standards prescribed in Rule 7 and QMS as prescribed in schedule 5. The product standards prescribed are BIS standards as first preference and if these are not available, ISO/IEC/ASTM standards, and if even these are not available, manufacturers can declare any validated standard. The QMS prescribed is based on ISO 13485 – unfortunately it’s based on the 2003 version of ISO 13485 and needs to be updated to the latest 2016 version of ISO 13485. It produces a piquant situation where the manufacturer has to implement ISO 13485:2016 for registration and yet revert to the older version for compliance to MDR – something for Central Drugs Standard Control Organisation (CDSCO) to attend to on priority. Further, MDR, 2017 does not require ISO 13485 certification and the certificates, now a requirement for registration, would no longer be needed once MDR is fully implemented. However, it would be advisable for the industry to hold on to such certificates like ISO 13485 since these have global acceptance,” Jauhri explains.
Talking about the indigenous certifications scheme, Pavan Choudary, Chairman, Medical Technology Association of India (MTaI), said “Despite having an established regulatory system in place, we are seeing that new quasi-certification schemes such as ICMED Plus are being launched which are not only redundant but also confuse the budding entrepreneurs and create compliance burden on SMEs”.
MTaI is an association of research-based medical technology companies who have made remarkable investments by setting up a large number of R&D centres and manufacturing plants in India.
“India, despite being a large market, still ranks 63rd in the Ease of Doing Business Index. The government admirably has held multiple consultation sessions recently to reduce the compliance burden for the industry. But these additional certifications, which were not required in the first place, will actually place additional hurdles and potentially risk inducing bias in procurements especially for domestic SMEs which constitute the most numerous cohort in the sector,” added Choudary.
There is no established regulatory regime today as new medical device regulations have not been implemented as yet as according to experts it will take another two years based on government notifications. Government had notified 18 months for voluntary registration of medical devices following which Class A and Class B medical devices will get time for licensing process for 12 months and another 12 months for Class C and Class D. This entire process will take time until October 2023 for the new regulations to get implemented.
Experts argue that regulations are still in transition period and will take time of another two years to be implemented and question how product quality can be assured in such scenario when licensing system is not in place. Voluntary certifications like ICMED Plus can therefore help in assuring product quality and safety of medical devices.