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Experts have cautioned that fake International Organization for Standardization (ISO) certificates claiming safety and quality of medical devices need to be verified by the private and government hospital procurement and purchasing agencies in India. It has been learnt that cases of fake certificates have been reported by government healthcare institutions and agencies running healthcare schemes in India in the past few years.
“This has been happening due to lack of awareness around verification of these certificates and associated accreditation systems globally. ISO 9001 certificate for any sector including Pharma and Ayush or ISO 13485 certificate for medical devices can be verified at https://www.iafcertsearch.org/. These fake certificates are issued by certifying agencies not accredited under the international system operated by International Accreditation Forum (IAF) which is now known as Global Accreditation Cooperation Incorporated (GACI). It maintains a global database of certificates for some of the ISO standards including ISO 9001 and ISO 13485 which are extensively sought in the healthcare sector,” informs Anil Jauhri, former CEO, National Accreditation Board for Certification Bodies (NABCB).
IAF CertSearch is the only global platform backed by the IAF, accreditation bodies, and certification bodies. It enables industry, regulators, and governments to verify some specific ISO certifications quickly and accurately.
From January 1, 2026, a new, single international accreditation organisation, GACI, has been established to bring together the work of the International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF). The formation of GACI will reduce duplication of efforts, harmonise accreditation policies and procedures and enable more consistent application of standards across sectors and borders.
There is a continuing risk of fake certificates on product quality flooding Indian medical devices market despite proper regulatory regime in place. A new medical device licensing regime- new Medical Device Rules (MDR)- 2017 has been implemented since October 1, 2023. While MDR, 2017 does not require ISO 13485 certificates and has instead prescribed its own quality management systems (QMS) vide Schedule 5, many manufacturers still go for ISO 13485 for its market value especially in global markets.
“Since the risk of fake certificates in India remains very high across sectors including for medical devices, the buyers or hospital procurement agencies should be careful while accepting any such certificates and verify them,” advises Jauhri.
The MDR, 2017, introduced by the Central Drugs Standard Control Organization (CDSCO), have adopted a risk-based classification system for medical devices, which is in line with the guidelines of the Global Harmonization Task Force (GHTF). This system categorizes medical devices into four classes based on the potential risk associated with their use: Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk).
Class A (Low Risk): Class A devices are non-invasive and generally do not come into contact with the patient or contact only the intact skin. Examples include devices like bandages, surgical masks, examination gloves, and tongue depressors.
Class B (Low-Moderate Risk): Class B devices are non-invasive but come into contact with intact mucous membranes. Examples include devices like hypodermic needles, suction equipment, and aerosol nebulizers.
Class C (Moderate-High Risk): Class C devices are invasive, entering the body through a body orifice or making contact with the internal body fluid path. Examples include devices like bone fixation implants, heart valves, and intraocular lenses (IOLs).
Class D (High Risk): Class D devices are invasive and come into contact with the cardiovascular system, and central nervous system, or are intended for life support or sustenance. Examples include devices like pacemakers, defibrillators, and implantable stents.
The classification is based on several factors, including the degree of invasiveness, duration of use, potential for local or systemic adverse effects, and the risk associated with the device’s intended use.
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