The most effective way to integrate CMDCAS requirements into Quality Manual

[gjhaddock]

1.How much of Canadian Medical Device Regulation needs to be imported verbatim?

2. Should this be in an appendix, or integrated into the specific elements/clauses?

3. Should the font be bold or italicized or flagged with a maple leaf or equivalent so the Canada-specific requirements are clear?

Any suggestions from people who have successfully implemented CMDCAS would be welcome.

Thanks

Jerry Haddock

 

[Bridget]

Blended into current manual

Hi Jerry,
I only referenced Canada on the cover of my manual along with the other standards we comply with such as ISO, MDD, FDA etc.
After reading the cmdcas regulations I already had procedures in place so I added their requirements into them and did not refer to Canada within the manual at all, only on the cover as stated above. I tend to make things as simple as possible. So far so good with the auditor.

There is another thread with links for info for Canada.

ISO 13485, FDA's QSR, CMDR, MDD: Correlation Matrix

In the beginning I had a lot of questions and found that when I emailed someone within Health Canada I received a prompt reply and when I called they were very helpful.

We can see what other might have to offer...
Bridget

 

[gjhaddock]

Thanks, Bridget.

I tip my cap your simple and elegant approach. Would you be willing to share some of your useful email and/or phone contacts at Health Canada?

Best Regards,

Jerry

 

[DannyK]

Jerry,

You should not have any problem meeting the requirements. Some of the requirements are:

1. Maintaining a file that has objective evidence establishing the safety and effectiveness of the device as required by Section 10-20, 32.

2. Referencing the Canadian medical device regulations within your documented quality system

3. Evaluation of the need for Risk analysis throughout the design process and maintaining records.

4. If a significant change to a class III and IV device is made, procedures shall address the regulatory requirements to apply for a medical device license amendment.

5. Labelling requirements Section 21-23

6. Validation of sterilization- records shall be maintained.

7. Distribution records- section 52-56 & 66

8. Characteristics & performance of Medical device are affected by storage or transport.

9. Complaint handling

10. Mandatory Problem Reporting

11. Recall


Check out the Health canada website:
(broken link removed)

Danny

 

[Bridget]

I agree

Jerry:
I agree with Danny and glad he was here to answer your questions. I have been busy with new customer regulations and have not had the time to get back to the cove.

If we can be of further help let us know.
Bridget