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The Central Drugs Standards Control Organisation (CDSCO) needs to sensitize manufacturers to implement registration process scheduled from October 1, 2022 for class A&B medical devices as per the mandate of new Medical Device Rules (MDR) – 2017, according to experts.
The new Medical Device 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 argue that there is no established regulatory regime today. It will take another two years to get implemented based on government notifications. Government has 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.
“Medical devices are not yet regulated. There will be some quality assurance once it is regulated and the licensing regime is in place. In the absence of regulations, the buyers or customers will not be assured of any quality. Unauthentic certifications will continue to rule the Indian markets,” experts lament.
According to a 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 systems (QMS) as per international standard, ISO 13485, in medical devices are unauthentic or fake.
However it has also been argued that before this is being considered, let us collect the evidences to prove the point that certifications, which are required for ISO 13485, are not properly issued and notified bodies are finding it difficult to carry out the ISO 13485, as many of the medical device manufacturers need their capacity building for maintaining compliance to norms.
In India, certification bodies should be accredited by the National Accreditation Board for Certification Bodies (NABCB) for undertaking certification as per ISO 13485 which is an international standard for Quality Management Systems (QMS) in medical devices and accepted by many regulators around the world.
The National Accreditation Board for Certification Bodies provides accreditation to Certification and Inspection Bodies based on assessment of their competence as per the Board's criteria and in accordance with International Standards and Guidelines.
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.
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