There is a continuing risk of unauthentic certificates on product quality flooding Indian medical devices market as Central Drugs Standard Control Organization (CDSCO) has postponed compulsory registration date from September 30, 2021 to May 31 2022 towards transitioning to a new medical device licensing regime- new Medical Device Rules (MDR)- 2017.
The new 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).
There is no established regulatory regime today. It will take another two years to get implemented based on government notifications. Government had notified 18 months for voluntary registration of medical devices with effect from April 1, 2020 following which Class A and Class B medical devices will get time for the licensing process for 12 months and another 12 months for Class C and Class D. This entire process will take time until October 2023 for the new medical device regulations to get implemented.
“Until the time regulations are not in place which will most likely come into being by October 2023, the manufacturers will show certificates most of which are unauthentic to impress the buyers who generally are ignorant. The risk of unauthentic certificates remains very high as medical devices are not yet regulated. Once regulated and licensing regime is in place, there will be some quality assurance. In the absence of regulations, the buyers or customers will not be assured of any quality. Voluntary unauthentic, even fake, certificates will continue to rule the Indian market,” pinpoints Anil Jauhri, former CEO, National Accreditation Board for Certification Bodies (NABCB).
NABCB is a MRA signatory for MD QMS as per ISO 17021 for QMS for medical devices under a broader framework.
CDSCO recently released a draft Medical Devices Amendment Rules, 2021 notification giving an extension for submission of ISO 13485 certificate for the purpose of registration for medical devices from the earlier date of September 30, 2021 to May 31, 2022 towards transitioning into the new medical device licensing regime as per MDR-2017.
According to an earlier notification issued by the Union Health Ministry on February 11, 2020, medical devices were subject to a voluntary registration scheme from April 1, 2020 to September 30, 2021. Class A and B medical devices were then subject to a mandatory registration scheme from October 1, 2021, until September 20, 2022, and Class C and D medical devices were subject to a mandatory registration scheme until September 20, 2023. Following the mandatory registration period, these classes will then transition to a licensing system.
Experts have revealed that a large number of certificates of certification for quality management system (QMS) as per international standard, ISO 13485, in medical devices are unauthentic or fake.
In India, certification bodies should be accredited by NABCB for undertaking certification as per ISO 13485 which is an international standard for QMS in medical devices and accepted by many regulators around the world.
NABCB provides accreditation to certification and inspection bodies based on assessment of competence as per the applicable international standards and guidelines. It is internationally recognised and represents the interests of the Indian industry at international forums through membership and active participation with the objective of becoming a signatory to international multilateral / mutual recognition arrangements (MLA/MRA).
It is also a member of International Accreditation Forum (IAF), International Laboratory Accreditation Cooperation (ILAC) and Asia Pacific Accreditation Cooperation (APAC) as well as signatory to its MRAs for QMS and product certification.
List of NABCB-accredited certification bodies for ISO 13485 for Medical Devices Quality Management Systems (MDQMS) are International Certifications Services Private Ltd, TUV SUD South Asia Pvt Ltd, Intertek India Pvt Ltd , TUV Rheinland (India) Pvt Ltd, DNV GL Business Assurance India Pvt Ltd, BSI Group India Pvt Ltd, TUV India Pvt Ltd, BSCIC Certifications Pvt Ltd, TUV InterCert Saar India Pvt Ltd, Zenith Quality Assessors Pvt Ltd and SGS India Pvt. Ltd.
An authentic certificate should contain the following like name and address of the organisation certified, scope of certification describing its activities under certification, standard (or sometimes scheme or regulation) against which certification is granted e.g. ISO 9001 or ISO 22000 (standard) or AS 9100 or FSSC 22000 (scheme). In general guidance standards are not amenable to certification. These have to be formal requirement standards or specifications
The authentic certificate should also include date of issue and expiry of certificate, unique identification number of the certificate, name and address of the certification body (CB), logo of the certification body, accreditation symbol indicating the name of the accreditation body (AB) which has accredited the certification body (in most countries, in the absence of any law requiring certification bodies to register, accreditation is the only way of recognizing a competent, authentic certification body).
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