Cross Reference Matrix for TGA and ANVISA requirements

E

Eddings135

I have a cross reference matrix that I've been using to perform internal audits. It compares the following standards: 21CFR820, ISO 13485:2003, ISO 9001:2008, MDD (93/42/EEC), SOR/98-282, and MHLW. I need to add both TGA (Therapeutic Goods Administration) and ANIVSA (Brazil) to the matrix. Does anybody have a cross reference list for TGA or ANVISA that correlates with any of the standards on my matrix? If not, can anyone point me to a website that may have a cross reference? Thanks in advance for any help.
 
Marc

Marc

Fully vaccinated are you?
Leader
Another quick "Bump". If anyone has anything like this your help will be appreciated.

Also - If the original poster has a matrix which cross-references 21CFR820, ISO 13485:2003, ISO 9001:2008, MDD (93/42/EEC), SOR/98-282, and MHLW - Could you share it with us?
 
Ronen E

Ronen E

Problem Solver
Moderator
Eddings135 said:
I have a cross reference matrix that I've been using to perform internal audits. It compares the following standards: 21CFR820, ISO 13485:2003, ISO 9001:2008, MDD (93/42/EEC), SOR/98-282, and MHLW. I need to add both TGA (Therapeutic Goods Administration) and ANIVSA (Brazil) to the matrix. Does anybody have a cross reference list for TGA or ANVISA that correlates with any of the standards on my matrix? If not, can anyone point me to a website that may have a cross reference? Thanks in advance for any help.
Click to expand...

TGA requirements align pretty well with the MDD. There are some minor differences in essence (as well as some, not that minor, in form) but unfortunately I neither have a detailed mapping nor aware of any website containing the same.
 
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