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Health ministry to launch ICMED-plus to address regulatory requirements of medical device product compliance
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Shardul Nautiyal, Mumbai
September 20 , 2018
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Aimed at creating a voluntary system of compliance for Indian medical device manufacturers, the union health ministry will soon launch Indian Certification for Medical Devices Scheme (ICMED)-plus, a third level of compliance meant to address regulatory requirements for product compliance.
ICMED - the first indigenously developed international class certification scheme for the medical devices in India, launched in 2016 - earlier addressed compliance for quality management systems (QMS) requirements only.
India’s apex quality facilitation and national accreditation body Quality Council of India (QCI) on March 15, 2016 launched ICMED for the medical devices manufacturers in India to reduce time and cost-run for obtaining globally accepted certification thus eliminating the malpractices of sub-standard or fraudulent certification or quality audits.
An initiative of Association of Indian Medical Device Industry (AIMED) in collaboration with QCI and the National Accreditation Board for Certification Bodies (NABCB), ICMED is aimed at enhancing patient safety and providing consumer protection and much needed product credentials to manufacturers for instilling confidence among buyers and users.
As of today, 23 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 certification is an option provided to the Indian manufacturers to demonstrate compliance to medical device (MD) rules.
This is also intended to help them get preference in public healthcare procurement scheme an agenda which is in the spotlight today besides the dialogue between industry and government that the ICMED certification should get formal recognition in the interest of Indian medical device industry. The idea of ICMED certification however is being opposed by certain section of importers and MNCs.
NABCB is accrediting certification and inspection bodies and its accreditation programmes are internationally equivalent placing it on par with European and American accreditation bodies. This equivalence would help facilitate acceptance of ICMED certification in overseas market.
The manufacturers would need to approach any one of the certification bodies approved by QCI under the ICMED scheme for obtaining certification. The certification bodies shall be under the oversight of NABCB, which as the national accreditation body, would accredit these certifying bodies as per applicable international standards.
To ensure need to have the highest Quality Standards, the Certification Scheme is built over the base Standard ISO 13485 (Quality Management System for Regulatory Purposes) which had 184 Compliance Requirements. The ICMED 13485 has in addition 23 regulatory requirements, 13 essential requirements for ensuring patient safety and with 16 labeling requirements for ensuring consumer protection. The Certification is available through NABCB accredited certification bodies of international repute for this Scheme - Intertek, UL, TUV Intercert, TUV.
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