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India should adopt ANAC usage of IAF CertSearch for verifying certificates of medical devices for QA: Experts

Shardul Nautiyal, Mumbai
Monday, January 30, 2023, 08:00 Hrs  [IST]

India should adopt the Italian Anticorruption Authority (ANAC) usage of the International Accreditation Forum (IAF) CertSearch for verifying certificates of medical devices for quality assurance (QA), according to experts.

IAF has recently announced that the ANAC has recognized the value of the IAF CertSearch database for confirming the validity of management system certificates required for participation in public tenders in Italy, and will move to exclusively using IAF CertSearch for these verifications.

IAF is a global association of accreditation bodies and other bodies interested in conformity assessment in the fields of management systems, products, processes, services, personnel, validation and verification and other similar programmes of conformity assessment.

“A global database of ISO certificates ISO 9001 to begin with would be an important tool to fight the menace of unauthentic and fraudulent certificates in the Indian medical devices market. Indian public procurement agencies like Government e Marketplace (GeM) should adopt the same approach,” pinpoints Anil Jauhri, former CEO, National Accreditation Board for Certification Bodies (NABCB).

The GeM is an online platform for public procurement in India. The initiative was launched on August 9, 2016 by the Ministry of Commerce and Industry, Government of India (GoI) with the objective to create an open and transparent procurement platform for government buyers.

There is a continuing risk of unauthentic certificates on product quality flooding the Indian medical devices market as the new Medical Devices Rules (MDR) 2017 are still in transition period and will take time of another two years till October 1, 2023 to be implemented completely.

Experts, therefore, question how product quality can be assured in such a scenario when the licensing system is not in place. Voluntary certifications, which remain the only option today, can help in assuring product quality and safety of medical devices to some extent but product certifications in medical devices are not yet popular either by Bureau of Indian Standards (BIS) or by Quality Council of India (QCI).

ANAC is an independent Italian administrative authority responsible for the prevention of corruption in public administrations. Until now, ANAC has been confirming the validity of certificates issued in Italy under accreditation by ACCREDIA electronically. This new development will allow ANAC to extend this type of control to all certificates that will be deemed admissible in Italy in public tenders.

The automatic verification will begin presumably on 1st September, 2023 and will initially be limited to ISO 9001 certified construction companies (IAF code 28), with plans to extend to other codes and management systems in the near future.

To ensure the best possible service and avoid any disruptions or inconveniences to accredited management system certification bodies and their customers, IAF is reminding accreditation bodies to upload their relevant accreditations to IAF CertSearch, and accredited certification bodies to upload their relevant certifications.

IAF CertSearch is a publicly accessible database that allows users to verify the validity of management system certifications issued around the world by certification bodies accredited by IAF MLA signatory accreditation bodies under the main scope ISO/IEC 17021-1. This announcement by ANAC further solidifies the value and importance of IAF CertSearch.

The risk of unauthentic certificates remains very high as medical devices are not yet regulated. Once the licensing regime is in place, there will be some quality assurance.


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