QMS to demonstrate Compliance to Canada, Europe and Japan

[SGquality]

Hello friends,

One of our US plants that is having ISO 13485 (ANAB) and complying to 21 CFR Part 820 is told by one of our customers to show compliance to Canada, EU and Japan regulations also.

Could you pls advise on path forward ?

Thank you,

 

[MIREGMGR]

Determine what the current systemic and product requirements are in each jurisdiction for your product type(s).

Modify your QMS so that it conforms to all applicable requirements.

Add internal and external resources as required, i.e. a European Authorized Representative if you don't already have one, possibly a Japanese responsible party, and so forth.

After you've planned your work, work your plan. Obtain the required registrations/licenses and so forth. Be sure that your Adverse Event reporting system conforms to the exact requirements of all jurisdictions. Modify your labeling as required.

 

[somashekar]

show compliance to Canada,

Who is your ISO13485 CB.
Find out if that CB also is recognized CMDCAS ISO13485 registrar.
If they are, then in your next assessment request for scope expansion to include CMDCAS.
If they are not, then it is better you work with a new CB who is a recognized CMDCAS ISO13485 registrar for your ISO13485 + CMDCAS ISO13485.

 

[sreenu927]

Hi Sgquality,

First do a correlation matrix or gap analysis with all these GMP or QMS requirements of Health Canada, Japan and EU MDD.

Close the gaps and ensure your QMS is in compliant to these GMPs and update your quality Manual.

For Health Canada (CAN/CSA ISO 13485), you need to get certified by third party certification bodies like BSI, SGS, etc..(as indicated by Somasekhar).

For EU, you need to appoint an EU Authorised representative, if you don't have an office location in EU. Need to have a signed agreement.

For Japan, you need to appoint (agreement is required) a MAH (Market Authorisation Holder) and obtain FMA (Foreign Manufacturer Accreditation).

Update your labeling with ECREP, CE Marking, appropriate safety symbols. To meet HC regulations, safety information must be in French Canadian in your user documentation.

Regards,
Sreenu

 

[MIREGMGR]

To meet HC regulations, safety information must be in French Canadian in your user documentation.

Actually, HC regulations provide for labeling and instructions of professional use devices to be in either English or French, at a minimum.

Quebec provincial law, however, conflicts with HC regulations and requires both English and French.

 

[SGquality]

Hi Sgquality,

First do a correlation matrix or gap analysis with all these GMP or QMS requirements of Health Canada, Japan and EU MDD.

Close the gaps and ensure your QMS is in compliant to these GMPs and update your quality Manual.

For Health Canada (CAN/CSA ISO 13485), you need to get certified by third party certification bodies like BSI, SGS, etc..(as indicated by Somasekhar).

For EU, you need to appoint an EU Authorised representative, if you don't have an office location in EU. Need to have a signed agreement.

For Japan, you need to appoint (agreement is required) a MAH (Market Authorisation Holder) and obtain FMA (Foreign Manufacturer Accreditation).

Update your labeling with ECREP, CE Marking, appropriate safety symbols. To meet HC regulations, safety information must be in French Canadian in your user documentation.

Regards,
Sreenu

Is a checklist available for doing gap analysis ?

 

[sreenu927]

No, I don;t have any!

 

[mcervantes]

does anyone have an example of a procedure referencing japan regulations?