TGA CER

#1
Hello Everyone, I wanted to ask for TGA CER are instruments applicable to an audit?

I am assuming for TGA CER class IIb implants and Class III devices the products are applicable to an audit, but for Class I & Class IIa devices they are not applicable to an audit? So for PMS data should I just exclude instrument Class I and Class IIa data?
 
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Ronen E

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#2
Hello Everyone, I wanted to ask for TGA CER are instruments applicable to an audit?

I am assuming for TGA CER class IIb implants and Class III devices the products are applicable to an audit, but for Class I & Class IIa devices they are not applicable to an audit? So for PMS data should I just exclude instrument Class I and Class IIa data?
Clarification required please.

What are you referring to in "instruments" and in "the products"? The terminology mostly applicable is devices, accessories, implants.

Also, not sure what you mean by "applicable to an audit". Normally TGA auditors might ask to review anything they feel is relevant to their audit, namely anything related to the medical devices and accessories withing the scope of certification. They are likely to just skim over items that are clearly related to Class I devices/accessories only, but they might still ask to review them.
 
#3
By instruments, I am referring to instruments such as Orthopaedic Bender, Surgical Distractor, Osteotome, rod reducer, scalpel, orthopaedic instrument extractor, bone tap, instrument tray, spinal guidewire, scalpel.

So would you recommend when running PMS data to include instruments? the reason I ask is because I usually run only implant PMS data
 

Ronen E

Problem Solver
Moderator
#4
I'm not sure what you mean by "run PMS data".

Are those "Orthopaedic Bender, Surgical Distractor, Osteotome, rod reducer, scalpel, orthopaedic instrument extractor, bone tap, instrument tray, spinal guidewire, scalpel" (sounds to me that at least some of them are devices) made by your company (and sold under its name)? If so, I would definitely include them in the scope of PMS activities. If not, I would consider it case by case. Some data might not be strictly required under the regulations but nevertheless necessary for context and insight.
 
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