ICMED Plus, a certification in question

The Quality Council of India (QCI) and the Association of Indian Manufacturers of Medical Devices (AiMeD) have added further features to the ICMED, the scheme that was launched for certification of medical devices in 2016. The ICMED 13485 PLUS, as the new scheme has been christened, will undertake verification of the quality, safety and efficacy of medical devices. The ICMED 13485 PLUS scheme was launched digitally recently.

ICMED 13485 Plus has been designed to integrate the quality management system components and product related quality validation processes through witness testing of products with reference to the defined product standards and specifications. This is the first scheme around the world in which quality management systems along with product certification standards are integrated with regulatory requirements. This scheme will be an end to end quality assurance scheme for the medical devices sector in India.

The Scheme provides the much-needed institutional mechanism for assuring the product quality and safety. It will go a long way in assisting the procurement agencies to tackle the challenges relating to the menace of counterfeit products and fake certification. This will also help in eliminating the circulation and use of sub-standard medical products or devices of doubtful origin that could prove to be serious health hazards.

The ICMED Scheme comprises ICMED 9000 and ICMED 13485 focuses on the Quality Management Certification schemes. The voluntary certification scheme was started to fill the then regulatory vacuum in quality certification space for medical devices in the country and was a culmination of extensive discussions with 22 government departments and industry.

The Scheme is modeled with quality management system for regulatory purposes (ISO 13485) as a subset and has 184 compliance requirements. While the ICMED 9000 and ICMED 13485 focused on quality management certification aspects, which have also now been adequately covered under the medical device rules (MDR)-2017, a need was felt to upgrade the scheme to protect the Indian consumers and industry from competition with substandard imported medical devices.

Therefore, an additional section of ICMED 13485 Plus designed in a manner that derives its QMS components from ICMED 13485 and expands the coverage through product related quality validation by integrating aspects of witness testing of products to defined product standards and specifications.

It is an institutional voluntary mechanism for assuring quality, helping procurement agencies that require evidence of product conformance, encouraging domestic manufacturer especially startup aiding Atmanirbhar Bharat robust mechanism to counter menace of counterfeits and non-authenticate certifications, capacity building of MSME/domestic manufacturers to comply to upcoming regulatory requirements.

As a step toward aiding public procurement and safeguarding private buyers and common consumers, ICMED Plus scheme can be an enabler in reducing regulatory oversights through a third party independent certification system. This will reduce costs by reducing the need for international auditors.

Some responses from industry:
“The launch of the ICMED Plus is a watershed moment. Coming, as it does, in the aftermath of the COVID-19 pandemic and at a geostrategically crucial time when the world looks beyond a few monopolistic countries, it could shepherd India to be one of the leading global manufacturers of quality medical devices,” says KL Sharma, Joint Secretary (retd.), MoH&FW and Chair of the ICMED Steering Committee.

‘The agility of the Indian medical device manufacturers to respond effectively to the COVID pandemic encouraged the QCI to further design an integrated product quality framework to support the medical device industry during these trying times’. QCI will always respond effectively to the requirements of the Industry and make sure that such voluntary efforts improve the regulatory requirements in the country,” says Adil Zainulbhai, Chairman, QCI.

“The need for an Indian Quality Certification System was never felt as strongly as during the current pandemic. Access to affordable and quality medical devices can be realized through ICMED Plus certification. ICMED Plus is voluntary product certification. Hence, there is no question of increased compliance burden for a manufacturer as he will seek it if he finds merit in it. Other countries do have voluntary certification in addition to regulations or to help regulators in reducing regulatory oversight such as European Union uses ISO/EN 13485, the US, Brazil, Canada, and Japan use MDSAP certification. The scheme allows Indian manufacturers to demonstrate compliance but on a voluntary basis as defined in India’s standards strategy launched last year in June,” says Rajiv Nath, Forum Coordinator, AiMeD.

“AHPI will encourage implementation of ICMED Plus among its members and stake holders’. He reminded the gathering that many organizations around the world have succeeded by reducing regulatory compliance through voluntary efforts. It would be in the interest of India manufacturing sector, if the DCGI starts using Certification bodies for verification of compliance in the medical devices,” says Dr Girdhar Gyani, SG, Association of Healthcare Providers (India).

This initiative is expected to provide much needed authentication to Indian manufacturers and their home-grown medical devices to easily comply with the international product standard requirements in the global market.

MTaI PROTESTS
Medical Technology Association of India (MTaI) has protested that the scheme has a real potential to cause more harm than good in many ways.

Some of the reasons include:
Redundancy of regulatory process. The industry already takes the required regulatory approvals from CDSCO and is currently facing the issue of multiplicity of regulatory authorities that cover the gamut of medical devices often encroaching on each other’s jurisdiction.

Impacts ease of doing business. India, despite being a large market, still ranks 63rd in 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 especially for domestic SMEs which constitute the most numerous cohorts in the sector.

Impacts investment opportunities. The FDI in MedTech sector has gone down to USD 21 million in the first quarter of 2021 (from USD 248 million in the same quarter in 2020) in a year where we could have seen the FDI going up due to global shift. Such certification schemes increase unpredictability, thereby decreasing the attractiveness further, as the global interests are unsure of whether or not they will have to comply with new certification schemes as they enter the country besides adding more hurdles and cost burdens on the industry, which will eventually result in higher costs and delays for patients.

“Any new policy should be evaluated on the basis of at least 3 factors: credibility, value, and applicability. Redundancy in regulations should be avoided. A sunrise sector like medical devices is best left with only globally recognized regulatory pathways, to help the industry focus more on actual growth rather than concern itself with these superfluous certifications,” says Sanjay Bhutani, Director MTaI.

“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 confuse the budding entrepreneurs and could burden SMEs, who aim to sell their medical devices globally – to the point of despair,” concludes Pavan Choudary, Chairman, MTaI.