There has been a considerable reaction among a section of India’s medical devices sector over the launch of a new voluntary product certification scheme christened ICMED 13485 Plus by the Quality Council of India, India’s apex quality body set up by the government in partnership with India’s leading industry bodies.
That the Indian Certification of Medical Devices (ICMED) Scheme is a joint initiative of QCI with a local industry body, Association of Indian Medical Devices Industry (AIMED), has added another dimension – of divergence of views in the industry on the new launch.
The new scheme has been termed as redundant or creating confusion or against harmonization with international standards.
Before considering the specifics of the scheme, it is important to understand the international scenario as well as the unique situation India faces when it comes to regulations and access to global markets.
Is voluntary certification needed in regulated sectors?
The criticism of the new scheme seems to suggest that once India transits to a regulatory regime, there is no need for a voluntary certification. However, this is globally not true – the most regulated sector, food, is full of private certification schemes like FSSC 22000, BRCGS, IFS, etc., which have such influence in specific markets that exporters, especially from developing countries, must comply with them to gain access. All one needs to do is to visit the site of the Global Food Safety Initiative (GFSI) and view its effort to minimize multiplicity of such schemes.
The examples of IATF 16949 in automotive sector and AS 9100 in aerospace sector are also examples of other regulated sectors having globally popular voluntary certification schemes.
In medical devices itself, ISO 13485 certification is voluntary and yet embraced globally.
Therefore, whether needed or not, certainly private certification schemes are quite prevalent in regulated sectors.
Is voluntary certification duplication of regulation?
There is an argument that ICMED Plus 13485 is redundant since India is transiting to a regulated regime.
There is no bar on certification to regulatory requirements – in fact, many countries including India, prescribe certification itself as a regulatory requirement and indeed the Food Safety and Standards Authority of India has prescribed certification by the national standards body, the Bureau of Indian Standards, as mandatory in its regulations for products like bottled water and milk powder, In fact, QCI had received a request from Indian department of traditional medicines (AYUSH) to set up a voluntary certification scheme for Indian systems of medicines like Ayurveda to regulatory requirements called AYUSH Standard Mark in 2009.
However, usually the voluntary certification schemes go beyond the regulatory requirements, and have add-on features.
Globally, they are seen as support to regulators and the global food standards body, Codex Alimentarius Commission, is actually brining out a guidance on how regulators should give consideration to private certification schemes.
The best option for Indian industry is if India’s regulations are harmonized with global regulations and the products as regulated are accepted abroad. However, India faces a peculiar reality – in many sectors, it does not have regulations like machinery or chemicals or agriculture today. Even medical devices industry is largely unregulated and obligation to comply with product standards does not become effective till August, 2022, for class A and B devices and August, 2023, for class C and D devices.
In several areas, where it has regulations, they are not harmonized with global regulations – be it food or gold jewellery or automobiles – either the standards specified are not global or the conformity assessment, e.g. BIS certification, being unaccredited is unacceptable.
Therefore, in order to seek acceptance of its certification by overseas regulators, India needs to create a separate system from regulations to certify to global standards. It has done that successfully, for example, in case of organic products where there were no regulations in early 2000s and a system was developed by APEDA, which is recognized by several countries, and in seafood where EC designated the Export Inspection Council (EIC) as the competent authority to certify to EC regulations in 1997 since our domestic regulations are not globally harmonized.
Are India’s medical devices regulations globally harmonized?
While notification of Medical Devices Rules (MDR), 2017, is an excellent step toward regulating medical devices in India, and the notification of definition of medical devices on February 11, 2020 is another laudable step, the regulations in India are not fully harmonized with the global regulations.
MDR prescribes compliance to BIS, which may not be harmonized with international standards, e.g., in case of PPEs. One wishes ISO/IEC standards were given primacy. Further, the QMS prescribed vide schedule 5 of MDR is not yet aligned to the latest ISO 13485 whereas ICMED 13485 standard subsumes both ISO 13485:2016 as well as Schedule 5 and, therefore, demonstrates compliance to both at the same time.
Therefore, any manufacturer complying with MDR, 2017 may not find acceptance in the overseas market.
Even BIS certification of PPEs, advised by the Ministry of Textiles, may not be acceptable abroad since BIS standards are not harmonized with global standards and BIS is not accredited for its product certification scheme, which is usually a requirement overseas.
How does ICMED 13485 Plus help?
Given the following situations:
- Compliance to MDR, 2017 does not become obligatory till August, 2023.
- MDR, 2017 is not totally aligned with global standards.
ICMED 13485 Plus provides a platform to the industry to show compliance to international (ISO/IEC) or internationally acceptable (EN/ASTM, etc.), using duly accredited certification bodies – thus making it harmonized with global practices.
In the immediate future, when there is no mechanism to demonstrate compliance to standards until licensing under MDR, 2017 becomes the norm after August, 2023, ICMED 13485 Plus certification should provide a platform to the industry to showcase compliance to global standards. In the long run, ICMED 13485 Plus certification should prepare the industry for global markets, and India could present this system for acceptance by overseas regulators.
The above narration should clear many misconceptions in the medical devices industry and stakeholders about the ICMED 13485 Plus certification that
- Voluntary certifications exist in many regulated sectors.
- Voluntary certifications are generally regulations plus, and so is ICMED 13485 Plus.
- It supplements the regulatory regime by helping Indian industry to prepare for global markets.
And finally, it is a voluntary certification scheme, which would grow only if it adds value to the industry.