Understanding ISO 13485 Certification and Its Role in Medical Device Registration
ISO 13485 is a critical standard implemented by organizations involved in designing, producing, installing, and servicing medical devices. It plays a crucial role in auditing processes for manufacturers, but there is often confusion among industry stakeholders about who can certify ISO 13485, which is a prerequisite for device registration under the MDR, 2017 by CDSCO.
The MDR, 2017 adopts the Notified Body (NB) concept, as practiced in the EU, for auditing Class A and Class B medical devices. As ISO 13485 consultants, we understand the distinctions between NBs, Certification Bodies (CBs), and other regulatory bodies, guiding our clients accordingly.
For further information on ISO 13485 certification and how it impacts medical device registration, feel free to contact us.
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ISO 13485 is implemented by organizations involved in designing, producing, installing, and servicing medical devices. It supports manufacturers in their auditing processes. However, there is industry ambiguity about who can certify for ISO 13485, a requirement for device registration under India’s MDR, 2017 by CDSCO.
MDR, 2017 adopts the EU’s Notified Body (NB) concept for auditing Class A and Class B medical devices. As ISO 13485 medical device consultants, we differentiate between NBs, Certification Bodies (CBs), and other regulatory bodies, guiding our clients accordingly.
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ISO 13485 Accreditation:
Medical device manufacturers who wish to sell their devices in the EU market need to have a relationship with the Notified bodies as these are the bodies whose role is to perform conformity assessment of new medical devices. Often these are private firms with experts from the field of risk management & medical device safety and standards. NBs are registered under rule 13 as a body that carries out an audit of manufacturing sites, assessment, and verification of specified categories to establish conformity assessment with standards. It does not mention ISO 13485 or the certification words.
ISO 13485 was introduced as a certificate of compliance accredited by NABCB (National Accreditation Board for Certification Bodies) or IAF in respect of medical devices.
This clearly indicates that ISO 13485 is obtained by a Certified body i.e. CB not from NB (Notified Body).
CB should be accredited by NABCB, the Indian National Accredited Body (AB).
Countries like the US and Japan have multiple Accreditation bodies (AB) whereas some countries have single national AB. ISO 13485 operates under the oversight of IAF through Abs in each country. IAF defines 7 technical areas in a document IAFMD which is free to download from their website. So, the bottom line is industry makes sure that the Certified body (CB) is accredited by an AB. The ISO 13485 should carry the logo of AB which will ensure that it is accredited for the scope under which your industry falls.
The point to remember is that there are a number of non-IAF CBs in the market that offer ISO 13485 certificates-beware of them. To get this certificate from the correct CB you should hire the right consultant, who has experience in the regulatory domain.
To summarize, a few points to remember
- ISO 13485 certificate is to be obtained from CB not from NB.
The certificate should be from a CB accredited by NABCB or any IAF member AB that seems to be present in India.
- The certificate should carry the logo of the AB.
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At Operon Strategist, we offer expert ISO 13485 certification consultancy to guide your organization through the complexities of medical device regulatory compliance. Our team understands the nuances of ISO 13485 certification, ensuring your readiness for the MDR, 2017 by CDSCO and other global regulatory standards. Trust us to navigate the certification process efficiently, enhancing your market access and product quality.
