Does a "Significant Change" apply to Class II Medical Devices?

[canreg]

We are a distributor of a medical device company in the UK who has a registered Health Canada Class II device. The company will shortly be changing their sub-contract mnf. to their own mnf. plant. As a result of the manufacturing location change, they will also change the sterilization method for this device. Change in manufacturing process does not change the device specifications.

As per the Medical Device Regulations, I understand that a Licence Amendment would result if:

a) in the case of a Class III or IV medical device, a significant change; (b) a change that would affect the class of the device; (c) a change in the name of the manufacturer; (d) a change in the name of the device; (e) a change in the identifier of the device and (f) a change in the medical conditions, purposes or uses

Since change in manufacturing facility & sterilization process is considered a “Significant Change” for only Class III & IV devices, does it apply for Class II devices? If so, the Amendment form for Class II does not indicate change in manufacturing facility & sterilization process as potential reason to apply for the amendment.

I'd really appreciate if someone could let me know whether the changes would require us to submit an amendment for the Class II device.

 

[Marcelo]

Re: Does a "Significant Change" apply to Class II devices?

Ins't this a "(c) a change in the name of the manufacturer;"?

 

[Marcelo]

Re: Does a "Significant Change" apply to Class II devices?

Also, you quality management system certificate won't be valid anymore, right?

 

[quest]

I have the same question regarding Class II devices and am hoping someone can provide guidance as to what can be licenced via a fax back form and what requires a device license amendment form.
The changes that require an amendment are stated in the CMDR but they don't seem to completely agree with what is stated on the Fax-Back form, particularly the statement "..please confirm that the proposed change does not alter the original range of sizes licensed..." and ..."etc". I can forsee a change that does alter the original range of sizes BUT does not change the manf name, device name, indications, or device idntifier (it adds, not changes). So, in this case, is a fax-back appropriate or an amendment? Also what is meant by etc.
Any guidance would be appreciated.

 

[RA Guy]

quest, I am not sure I understand your exact question.

Are you aware of the multiple types of fax back forms on the HC website?

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/fb_licnamechng_fm_modnomhom-eng.php

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/fb_mfrnamechng_fm_modnomfab-eng.php

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/fb_nonsigchng_fm_modnomimp-eng.php

and the types of non-fax back amendment forms?

I would be happy to respond further if you could clarify exactly what you are attempting to do.

Cheers,
RA Guy

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/md_licam_im_demmhom_cla2-eng.php

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licamm_demmhom_label_marque_priv-eng.php

 

[DannyK]

We are a distributor of a medical device company in the UK who has a registered Health Canada Class II device. The company will shortly be changing their sub-contract mnf. to their own mnf. plant. As a result of the manufacturing location change, they will also change the sterilization method for this device. Change in manufacturing process does not change the device specifications.

As per the Medical Device Regulations, I understand that a Licence Amendment would result if:

a) in the case of a Class III or IV medical device, a significant change; (b) a change that would affect the class of the device; (c) a change in the name of the manufacturer; (d) a change in the name of the device; (e) a change in the identifier of the device and (f) a change in the medical conditions, purposes or uses

Since change in manufacturing facility & sterilization process is considered a “Significant Change” for only Class III & IV devices, does it apply for Class II devices? If so, the Amendment form for Class II does not indicate change in manufacturing facility & sterilization process as potential reason to apply for the amendment.

I'd really appreciate if someone could let me know whether the changes would require us to submit an amendment for the Class II device.

Please refer to Health Canada Guidance document "Guidance for the Interpretation of Significant Change of a Medical Device." I would call up Health Canada to find out what needs to be done. A client of mine changed their supplier for the class II medical and had to complete a form for supplier change.

 

[quest]

Thank you for your responses.
I am aware of the multiple fax-back forms as well as the multiple amendment forms.

I guess the exact question is..

If I want to add to a current license, a Class II device that is identical in every way EXCEPT for size (needle that is 1 inch longer than the length range currently licensed) what form is recommended?

 

[canreg]

Re: Does a "Significant Change" apply to Class II devices?

Thank you for your responses. The manufacturer's name/address on the HC Licence will not change so it could not be c). since the change is only in the sub-contractor's manufacturing location to their own. I believe if it is neither of the above, then the change needs to be documented in the manufacturer's quality management system.

 

[canreg]

Thank you for your responses.
I am aware of the multiple fax-back forms as well as the multiple amendment forms.

I guess the exact question is..

If I want to add to a current license, a Class II device that is identical in every way EXCEPT for size (needle that is 1 inch longer than the length range currently licensed) what form is recommended?

So, the current licence must be licenced as a "Family", correct?

Is there is another device/needle with the exact same description registered on the HC Licence? If so, then a Licence Amendment Fax-back form for non-significant additions of catalogue numbers can be filled and sent to Health Canada. This is acceptable as long as the proposed change does not alter the original range of sizes licensed or original indications of use.
(i.e. Multiple device identifiers each indicating a device of different size can be added to the licence only if the description on the label groups them together as family)

If the description on the label of the new device is different, then a Class II amendment form must be filled and sent to HC.

Hope this helps.