Regulatory Open Forum

Hi,

Does any one have experience with submitting a non-significant/Administrative Class III Amendment Submission with Health Canada? I believe it is a kind of alternative (not exactly) to submitting multiple fax-back forms (to implement name/address change, non-significant changes etc.).

While I got to know it recently, I could not find any reference to Administrative Amendment in Health Canada website. Through this instrument change in device name (section 10 of the application form) and addition of new identifiers (section 11A of the application form) can also be completed. Multiple Fax-Back applications are not required. As I understand, we just need to submit Class III/IV Medical Device License Amendment Application Form & indicating zero dollars for an administrative amendment in Fee form. There is no need of submitting a Technical file for this kind of submission.

I request anyone experienced with this pathway to validate my understanding and suggest what kind of ToC (Table of contents) need to be submitted to Health Canada.

Thanks in advance.

Sravan 

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Sravan Kumar Manchikanti, RAC
Hyderabad
India
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Hi,

Does any one have experience with submitting a non-significant/Administrative Class III Amendment Submission with Health Canada? I believe it is a kind of alternative (not exactly) to submitting multiple fax-back forms (to implement name/address change, non-significant changes etc.).

While I got to know it recently, I could not find any reference to Administrative Amendment in Health Canada website. Through this instrument change in device name (section 10 of the application form) and addition of new identifiers (section 11A of the application form) can also be completed. Multiple Fax-Back applications are not required. As I understand, we just need to submit Class III/IV Medical Device License Amendment Application Form & indicating zero dollars for an administrative amendment in Fee form. There is no need of submitting a Technical file for this kind of submission.

I request anyone experienced with this pathway to validate my understanding and suggest what kind of ToC (Table of contents) need to be submitted to Health Canada.

Thanks in advance.

Sravan 

Hello Sravan
There is no guidance on Administrative Amendment. Usually, this is submitted for multiple changes or changes that cannot be submitted through a fax-back. Faxback is pretty limited. Follow the folder structure (ToC structure for Class II, III, IV). It's the same format for regular amendments. Write a clear cover letter clarifying what it is you are seeking.  Hope it helps.

Hi,

Does any one have experience with submitting a non-significant/Administrative Class III Amendment Submission with Health Canada? I believe it is a kind of alternative (not exactly) to submitting multiple fax-back forms (to implement name/address change, non-significant changes etc.).

While I got to know it recently, I could not find any reference to Administrative Amendment in Health Canada website. Through this instrument change in device name (section 10 of the application form) and addition of new identifiers (section 11A of the application form) can also be completed. Multiple Fax-Back applications are not required. As I understand, we just need to submit Class III/IV Medical Device License Amendment Application Form & indicating zero dollars for an administrative amendment in Fee form. There is no need of submitting a Technical file for this kind of submission.

I request anyone experienced with this pathway to validate my understanding and suggest what kind of ToC (Table of contents) need to be submitted to Health Canada.

Thanks in advance.

Sravan