Understanding Who Can Certify For ISO 13485

 

Anil Jauhri Ex-CEO, National Accreditation Board for Certification Bodies (NABCB)

There is considerable confusion among the industry and other stakeholders about who can certify for ISO 13485 which has been put as a requirement for registration under the Medical Devices Rules (MDR), 2017 by CDSCO. It is necessary to understand the regulatory requirements as also the ecosystem for ISO 13485 certification. MDR, 2017 has adopted the concept of ‘Notified Bodies’ (NBs) as practices in EU who are to be utilized for the purpose of audits under MDR for class A & B medical device manufacturers.   Let us see what NB means in MDR, 2017: “Notified Body” means a body corporate or other legal entity, registered under rule 13 as a body competent to carry out the audit of manufacturing site, assessment, and verification of specified category of medical devices for establishing conformity with standards;

Therefore NB is meant to carry out audit of manufacturing facility to establish conformity with standards for specified categories – i.e. class A & B.

Quite clearly, it does not mention certification nor ISO 13485 – in fact in MDR 2017, as issued originally, there is no mention of ISO 13485 and word ‘Certification’ figures only once – as part of name of NABCB!

When the system of registration was introduced vide the notification dated 11 Feb 2020, then a requirement for ISO 13485 certificate was introduced as follows:

(iii) certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device.

This clearly indicates that ISO 13485 certificate is to be obtained from a certification body (CB) and not NB.

The CB should be accredited by NABCB, the Indian national accreditation body (AB), and list of such CBs can be seen on NABCB website at link

https://nabcb.qci.org.in/accreditation/reg_bod_mdqms.php Currently 14 CBs are accredited by NABCB and industry is free to go to any of them.

MDR also allows certificates from any CB which is accredited by member of International Accreditation Forum (IAF) – you can check names of such ABs on IAF website iaf.nu.

The system of ISO 13485 certification operates under the oversight of IAF through ABs in each country – some countries have single national AB, in Europe by law, some countries like USA or Japan or Korea have multiple Abs.

IAF also specifies scopes of accreditation and it is important that the CB industry chooses is accredited for the scope under which its operations fall – e.g Active Implantable Medical Devices or In vitro Diagnostic Medical Devices or Parts & Services. There are 7 such Main Technical Areas defined by IAF in a document IAF MD
8 which is free download from IAF website.

Rather than go into such details, the industry should just make sure that the CB is accredited by an AB which figures on IAF website and the ISO 13485 certificate carries the logo of the AB which would ensure that it is accredited for the scope under which your industry falls.

There are a number of non IAF CBs in the market offering ISO 13485 certificates – beware of them.

To sum up:

1. It is NOT required to secure ISO 13485 certificate from a notified body.

2. The certificate should be from a CB accredited by NABCB or any IAF member AB like IAS (USA) or EGAC (Egypt) or JASANZ (Australia) or KAB (South Korea) or UAF (USA) or UKAS (UK) or DAKKS (Germany) which seem to be having presence in India. This list is illustrative only.

3. The certificate should carry logo of the AB which would ensure that the CB is accredited for the scope under which your industry falls..