Mumbai: In order to create an ecosystem for quality as part of Mission Aatmanirbhar Bharat to enhance prospects of Indian medical devices sector, the Quality Council of India (QCI), and the Association of Indian Manufacturers of Medical Devices (AiMeD) have jointly come up with the Indian Certification for Medical Devices (ICMED) Plus Scheme. 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.
The ICMED 13485 PLUS, as the new scheme has been christened, will undertake verification of the quality, safety and efficacy of medical devices.
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.
Adil Zainulbhai, chairman, QCI, commented, “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.”
This 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.
Rajiv Nath, forum coordinator, AiMeD said, “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 realised through ICMED Plus certification.”
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.
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.
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 towards 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.