R
rayahuang
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??
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??