Notified Body Short List
This link shows quality system registrars who are recognized by Health Canada:
Health Canada Happy Registrar List
The fact that these bodies have gone to the trouble and expense of seeking Canada recognition is indicative of their commitment to medical device quality system registration. If you ever want to market devices in Canada you will need to be using one of those registrars. Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars.
There are 74 Notified Bodies for the Europe Medical Device Directive (MDD) and 19 Notified Bodies for the Active Implantable Medical Device Directive (AIMDD).
- 14 of the "MDD 74" are on the Canada list
- 8 of the "AIMDD 19" are on the Canada list
Excluding Australia's TGA (available only to Australia manufacturers) here is my "short list" of 13 Notified Bodies who can all handle devices under the MDD:
BSI*
DQS^
DEKRA*
Intertek^
LGA Intercert*
LNE/G-MED*
LRQA^
NSAI*
SGS^
TUV Rheinland*
TÜV SÜD*
TÜV NORD* (TUV USA)
UL^
* Notified Body for MDD and AIMDD
^ Notified Body for MDD but not AIMDD
Choose carefully.
* Notified Body for MDD and AIMDD
^ Notified Body for MDD but not AIMDD
Choose carefully.
Europa Links:
Notified Bodies for Medical Device Directive (MDD)
Notified Bodies for Active Implantable Medical Device Directive (AIMDD)
Notified Bodies for Active Implantable Medical Device Directive (AIMDD)
