Global Medical Device Consulting
- ISO 13485
- US FDA GMP
- JAPAN ORD. 169
- BRAZIL GMP
- CANADA CMDCAS
List of Notified Bodies, Registrars, Conformity Assessment Bodies - ISO 13485 Consultants
Below is a list of well respected organizations (in alphabetical order) authorized to audit medical device and IVD companies to ISO 13485:2003. National governments (and corresponding regulations) refer to these auditing and testing companies differently depending on the scope of certification they are allowed to grant by a national Ministry of Health. Many of the companies listed below are authorized to perform all four of these functions and therefore we refer to them collectively as “Certification Bodies.”
Notified Body – Authorized to European national Ministries of Health to audit to ISO 13485 and various EU Medical Devices Regulations for CE Marking. See below.
Registrar – Authorized by Health Canada to audit to the Canadian Medical Device Regulations (CMDR). Registrars must be accredited to the Canadian Medical Devices Conformity Assessment System (CMDCAS) to perform audits to the CMDR. Registrars cannot issue CE Marking certificates unless they are also a European Notified Body.
Registered Certified Body – Term used to conduct companies that the Japanese Ministry of Health, Labour and Welfare (MHLW) has authorized to conduct audits to the Pharmaceutical Affairs Law and Ministerial Ordinance #169, which is based on ISO 13485:2003. At this time, RCBs are only authorized to audit manufacturers of certain Class II medical device manufacturers.
Conformity Assessment Body – Authorized by the Australian Therapeutic Goods Administration (TGA) to perform audits for compliance with the Therapeutic Goods Act.
We also have a page where you can read more about how to evaluate and select the right Certification Body for your ISO 13485 registration audit.
AUSTRALIA – Conformity Assessment Bodies authorized by the Australian TGA
Opens PDF document from the TGA website
CANADA – Registrars authorized by Health Canada
Links to Health Canada website
EUROPE – EU Notified Bodies authorized to conduct audits to following directives:
