Re: Medical Device Registration Process in Brazil - Anvisa
Just to clarify the registration holder situation, we have a subsidiary company in Brazil that is mostly just sales marketing, logistics and a pharmacist (whatever we needed to open shop in Brazil . We used to use a 3rd party regulatory partner to help guide us, but just as you mentioned, they did not seem to have a mastery of the regulations, so we have begun taking care of our own registrations. So far we have had no problems.
Ah ok, now I understand... it's really a shame that there a re lot of those in Brazil :-(.
And it's always better to manage your all registration if you can, a lot of companies are getting to this conclusion.
Now in response to your latest comments, can I get a copy of the "technical note" off the ANVISA website?
It's this one:
NOTA TÉCNICA N001/2010/GGTPS/ANVISA
Lastly, are you suggesting that there is "insider information" for planning the BGMP inspections? Do we need to have a consultant help with the planning? Or is this something we can do ourselves, using the steps outlined in the regulations?
Well, there's in fact two points here. Maybe three
One - there's always inside information related ANVISa requirements, because the regulations are not always clear and then there's a lot of interpretations of the regulations.
Two - because of those uncertainties, I always say and maintain that a regulatory strategy plan for each device or family, or at least a for types of devices, is a must to make sure that all factors (official and inside info) are taken into account and the best pathway is chosen. This is even more so because the business impact is usually worse in Brazil - example, if you did not know that for the registration you need to obtain the GMP certificate, you will need to wait right now at least two years to get it - a pretty long time.
Third - for the inspections, it's common knowledge that you do have to send someone together with the inspectors (not required by law but expected by ANVISA and a risk if you do not do it).
Worse, I usually advise getting ready for the inspection long before it.
For example, what I usually suggest to my clients (but which could also be done internally if you have people with the right knowledge):
1 - Perform a work of adaptation of the plant quality system to Anvisa requirements and interpretations. RDC 59 is already a mess being a mix of 21 CFR 820 1978 and 21 CFR 820 1996. Besides that, Anvisa inspectors can have some weird interpretations of their own requirements.
This adaptation needs to be performed both in documents and physically because Anvisa inspectors loves documents but are always very visual - they have some strict interpretations of thinks like identifications and cleanliness and the like.
2 - Have someone form Brazil, usually the same guy who performed the first step, accompany the inspectors during the inspection. This is really a must for some reasons:
- A lot of Anvisa inspectors do not speak english
- They feel better if someone from Brazil is present
- The accompanying person can act as bridge between the inspectors and the plant
- If accompanying person knows the plant quality system (for example the person which did step 1) it can surely help showing compliance during the inspection or solve NCs during the inspection
- This is somewhat costing, but failing the inspections means that you will have to wait another to be inspected again - this is a great business risk.
