Understanding Who Can Certify For ISO 13485
National Accreditation Board for Certification
|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.
is necessary to understand the regulatory
requirements as also the ecosystem for ISO 13485
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
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
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
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