1. B-GMP
- is this a mandatory requirement
B-GMP is mandatory for all medical devices. The B-GMP certificate is required for some.
- would ANVISA able to conduct this audit
Anvisa conducts the audit.
- would there be any other organization/3rd party who conducts this audit
No.
- when can we expect this audit
It depends on when you requires the audit. Right now there´s months for the schedule.
- How can we argue that this audit is not necessary
You can´t.
2. electro medical equipment certification & relevant audit
- did i understand right that this is INMETRO mark
Yes.
- which resolution and regulation of ANVISA cites this requirement - is it RDC 32-2007 & IN 08-09. do you have these in English
Yes. No, not in English.
- what is the INMETRO certification process
Process for certifying medical electrical equipment according to IEC 60601 series of standards.
- does it involve a audit/factory inspection
Yes.
- who are authorised to do this
product certification bodies accredited by Inmetro for this scope.
- can we argue anything against having the audit - i believe this might not be different from other audits we have for our produc certification
No. According to the new regulation which wil be published may/june 2010, you can use a valid ISO 13485 certificate or B-GMP certificate for accepting part of the requiements, but there will still be a need to audit some other parts.
- Since we have periodic CSA audits, can this satisfy the requirement
No.
- our Lab is accredited by DA Tech which is a ILAC member. does this argue our case for not having one more audit
No. Audit (certificiation bodies) and test reports (testing laboratories) are two different parts of the process.
- we also have our notified body, can our notified body help in this case, if so how
If your notified body certifies your ISo 13485 system (and it has a MOU with the brazilian certification body and fulfills some other requirements) you can use this certification as mentioned above.