Canada Medical Device - Definition of "Manufacture", "Company? and "Distribute"

Dear all,
I have some question about the definition of "Manufacture" ?Company? and "Distribute"
Does the name on the device label need to definition as ?Manufacture? ?
Can it be the ?Company? or ?Brand? .?
Does the Manufacture most need to have iso13485 certificate ??

There are our situations below.

We (Company A) our iso13485 certificate is expired now, and we need to submit new certificate to health Canada,but we don?t has iso13485 system anymore. We has one product license in Canada.

Company B, has iso13485,and they will manufacture our product which has Company A label on the product.

What should we do? We think there have three ways to Application for a Medical Device License, can they all works?

(1) Private label
Company A : Private label (No iso13485 certificate,Name on device label)
Company B : Orinigal Manufacture((Has iso13485 certificate)

(2) Compay A Submit Company B 's iso13485 certificate to health Canada to renewal.
Company A : Company (No iso13485 certificate, Name on device label)
Company B : Manufacture((Has iso13485 certificate)

(3) Compay A Submit Company B 's iso13485 certificate to health Canada to renewal.
Company A : Distribute (No iso13485 certificate, Name on device label)
Company B : Manufacture((Has iso13485 certificate)

Anyone can help me??

Re: Canada medical device - definition of "Manufacture" ?Company? and "Distribute"

A Quick Bump!

Can someone help?

Thank you very much!!

Option (1) is your only option--Company A cannot license a Class II-IV device under their name by simply submitting Company B's certificate.

Note that for Option 1 to work, the original manufacturer also needs a medical device license for the product in their name.

All of your examples are noting that Company A's label will be on the device. The Canadian regulations are very clear that regardless of who actually manufactures the device, Company A would be considered to be the "manufacturer" and they must be certified to ISO 13485.

The private-label provisions were put in place because of retail chains who sell their private-label brand of some medical devices who did not actually manufacture the device. When companies like Walmart or Shopper's Drug were told they were the "manufacturer" and had to be ISO 13485 certified, they rightfully had serious issues with this. Health Canada now allows these private label retailers to license their products as the manufacturer while referencing the ISO certification and license of the original manufacturer.

But your situation doesn't sound like it fits in the scenario above. You'll either have to re-certify and get a license, or you'll have to market the product as a distributor of Company B's labeled and licensed product.

Option 1 is not exclusive to retailers. If you follow the guidance document on private label medical devices (2011), you should have no problems getting a license.

The biggest hurdle is often convincing your private label manufacturer to go along with it.

rayahuang said:

What should we do? We think there have three ways to Application for a Medical Device License, can they all works?

(1) Private label
Company A : Private label (No iso13485 certificate,Name on device label)
Company B : Orinigal Manufacture((Has iso13485 certificate)

(2) Compay A Submit Company B 's iso13485 certificate to health Canada to renewal.
Company A : Company (No iso13485 certificate, Name on device label)
Company B : Manufacture((Has iso13485 certificate)

(3) Compay A Submit Company B 's iso13485 certificate to health Canada to renewal.
Company A : Distribute (No iso13485 certificate, Name on device label)
Company B : Manufacture((Has iso13485 certificate)

Anyone can help me??

Click to expand...

The only way to get a license is if the manufacturer has ISO 13485 +CMDCAS requirements from an approved CMDCAS registrar.
If company B has an ISO 13485:2003 certificate + CMDCAS and the scope of the certificate includes the medical device, then they can apply for the license from Health Canada. Once they get the license, Company A can enter into a private label agreement with company B and submit a private label application to Health Canada.

I have submitted many applications for private label medical devices and I usually get the license within 2-3 weeks from Health Canada. If your application is done correctly there should be no problem.

Dear all,
If I go by Option 1
Can I Transfer Company A's MDL to Company B by change mdl?
And Company A application private label ?

rayahuang said:

Dear all,
If I go by Option 1
Can I Transfer Company A's MDL to Company B by change mdl?
And Company A application private label ?

Click to expand...

Does Company B have an ISO 13485 CMDCAS certificate with the scope that includes the medical device?

yes
B has iso13485 and NB is SCC accredited.