Association of Indian Medical Devices Industry (AiMeD) congratulated and praised the National Accreditation Board for Certification Bodies (NABCB), India’s national accreditation body, for securing international equivalence for its accreditation programme for Medical devices – quality management systems (MDQMS) certification bodies. NABCB-QCI signed the Multilateral Mutual Recognition Arrangement (MRA) of the Asia Pacific Accreditation Cooperation (APAC) for its accreditation programme based on international standards, ISO 17021-1 and ISO 13485.

The elated Mr. Rajiv Nath, Forum Coordinator, AiMeD said “What this international recognition means for Indian Manufacturer is access to lower cost indigenous QMS Certification rather than seeking it from overseas EU & US Certification bodies with prohibitive travel and auditor costs; access to local certification based on lower man-day auditor costs & will allow greater credibility of quality of Indian medical Devices Manufacturers and enhanced global competitiveness from Brand India. Next steps will be world recognition via IAF (International Accreditation Forum).

Mr. Anil Jauhri, Ex CEO NABCB and member of UNFCCC CDM accreditation panel & an IAF Evaluator explained “This is a step towards global recognition of ISO 13485 certificates issued in India under NABCB accreditation and bearing NABCB logo. Next step would be to apply to International Accreditation Forum and sign their MRA to get global recognition. Then IAF Mark can also be used on certificates issued in India. Since ISO 13485 is adopted in regulations in many countries including EU and USA, it would promote acceptance of Indian medical device manufacturers in these countries which are heavily regulated.”

Now any industry carrying ISO 13485 certificate with NABCB logo will be recognised in Asia Pacific Region. The immediate beneficiary of this equivalence will be the Indian industry which is exporting products to various 28 Asia Pacific Countries which covers China, Japan, Philippines, Indonesia and ASEAN Bloc of Singapore, Malaysia, Thailand, Vietnam etc. It can also be used by regulators for establishing confidence in certified units.

This is a step towards signing the Multilateral Mutual Recognition Arrangement (MLA) of the International Accreditation Forum (IAF) which would confer worldwide equivalence to NABCB’s Medical device- Quality Management Systems certification bodies’ accreditation programme.

The MRA covers accreditation programme based on international standards, ISO 17021-1 and ISO 13485.

NABCB, a constituent Board of the Quality Council of India, is responsible for accreditation of certification/inspection bodies as per applicable international standards under an international system of equivalence and along with QCI runs the Indian Certification of Medical Devices ‘ICMED’ Scheme with AiMeD (Association of Indian Medical Device Industry) of which ISO : 13485 is a subset Certification.

It may be added that APAC is the association of Accreditation Bodies and other bodies interested in the field of management systems, product, services, personnel and other similar certification programme in the Asia Pacific region. APAC is one of the five specialist bodies of the Asia Pacific Economic Cooperation (APEC).

This MRA signed by the two Bodies signifies that the accreditation of Medical devices – Quality Management Systems bodies by NABCB is now accepted as internationally equivalent within Asia Pacific Region. NABCB APAC MRA is a step towards signing the Multilateral Mutual Recognition Arrangement (MLA) of the International Accreditation Forum (IAF) which would confer worldwide equivalence to NABCB’s MDQMS certification bodies’ accreditation programme, a release by NABCB stated.

NABCB has already secured international equivalence for its accreditation programme for ISO 9001 certification bodies in 2002 and ISO 14001 certification bodies in 2007.

Accreditation reduces risk for business and its customers by assuring that accredited Conformity Assessment Bodies (CABs) are competent to carry out the work they undertake within their scope of accreditation.

Accreditation has become an essential tool for getting acceptance of inspection, testing and certification done in India internationally and it is referenced in many bilateral Free Trade Agreements like the India – Singapore Comprehensive Economic Cooperation Agreement in which NABCB accreditation is a requirement for certification of electrical/electronic and telecom products. Thus, accreditation eliminates technical barriers to trade and facilitates export of Indian products in world market.

NABCB has currently accredited 11 certification bodies for Medical device – quality management systems and has 9 applicants in process.