Factory Inspection to Register and Certify a Medical Device in Brazil

Marcelo

Inactive Registered Visitor
#21
Usually from 6 to 10 months, but Anvisa is late in all registrations due to someproblems. A 8-12 months estimate is a better guess right now, but it can go beyond 12 months.
 
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K

krishna007

#23
Dear Marcelo & Fellow Covers

we manufacture and want to register a Class IIb (in EU) device in Brazil. as you previously mentioned:

there would be 2 audits
1.B-GMP inspection
2.electro medical equipment certification

I have Questions on both:

1. B-GMP
- is this a mandatory requirement
- would ANVISA able to conduct this audit
- would there be any other organization/3rd party who conducts this audit - when can we expect this audit
- How can we argue that this audit is not necessary

2. electro medical equipment certification & relevant audit
- did i understand right that this is INMETRO mark
- which resolution and regulation of ANVISA cites this requirement - is it RDC 32-2007 & IN 08-09. do you have these in English
- what is the INMETRO certification process
- does it involve a audit/factory inspection
- who are authorised to do this
- can we argue anything against having the audit - i believe this might not be different from other audits we have for our produc certification
- Since we have periodic CSA audits, can this satisfy the requirement
- our Lab is accredited by DA Tech which is a ILAC member. does this argue our case for not having one more audit
- we also have our notified body, can our notified body help in this case, if so how

I am sorry to have set a flurry of questions. But i really need some help here!

Eager to see your feedback.

Greetings, Krishna
 

Marcelo

Inactive Registered Visitor
#24
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.
 
D

DesiQE

#25
Marcelo,

Thanks for the great insight into the ANVISA. We were just told by our distributor for class III medical devices that for the next few products we register, we will be needing the ANVISA GMP certificate. From all the inputs from you, I gather that although we have ISO 9001 & ISO 13485, we will still be audited. Would you know of any consultant in India that would help us get there? As ANVISA is so close to US FDA GMP (like you mention), this would be nice to have as a step toward US FDA.

:thanks:
 

Marcelo

Inactive Registered Visitor
#26
From all the inputs from you, I gather that although we have ISO 9001 & ISO 13485, we will still be audited.
ou correct, even having cartification for ISO 9001 and ISO 13485 you will stil need to be audited by Anvisa.


Would you know of any consultant in India that would help us get there? As ANVISA is so close to US FDA GMP (like you mention), this would be nice to have as a step toward US FDA.
Sorry, i do not know of any consultant abroad that knows the brazilian regulation, as close to the GMP as it gets. There´s two main problems here:

1 - the portuguese language

2 - the fact that Anvisa inspectors have their own "way" of seeing things..so, it´s interesting to have info on other inspections as a way to better help - this info is also difficult for consultants from abroad to have.
 
J

jewels

#27
Does anyone know if the Anvisa requirements have changed lately. We were working with a distributor early in 2009 and got all the documents to them and then they said it was too late to send them in. That they had a deadline with Anvisa to submit the documents and that deadline passed. So we identified a different distributor.

Now we're working with a new distributor and they are pushing to get the supporting documents to send to Anvisa quickly. In their push, they told me that requirements changed as of July 1, 2010 requiring inspection of the manufacturing facility annually at a cost of $20,000 each year. I can't believe
that Brazil would require annual inspection of our facility each year???? We are ISO13485, our products are CE marked and we obtain US FDA 510(k) clearance for our products. This proposed inspection seems way over the top!

Were there any changes to the Anvisa requirements for diagnostic testing kits (medical devices) in the last year or so?

And if anyone has any information on inspections....please enlighten me. This is all new and from my understanding all the documents available from Anvisa are in Portuguese. Are there US based inspectors that can do this inspection at a more reasonable cost than $20,000 if this truely is something we're going to need to do?

Thanks!!!!!
 

Marcelo

Inactive Registered Visitor
#28
Does anyone know if the Anvisa requirements have changed lately.
There´s been a lot of modifications in the past year or so. Please take a look at this thread - Medical Device Registration Process in Brazil - Anvisa - for more info.

In their push, they told me that requirements changed as of July 1, 2010 requiring inspection of the manufacturing facility annually at a cost of $20,000 each year.
The requirements changed as of May 21 to be more precise - one year after the publication of RDC 25, which is the regulation which now requires a B-GMP for some devices. I thinsk someone should have told you this way before.

I can't believe that Brazil would require annual inspection of our facility each year????
It´s being required.

We are ISO13485, our products are CE marked and we obtain US FDA 510(k) clearance for our products.
It does not matter as those are not "recognized" by Anvisa.

This is all new and from my understanding all the documents available from Anvisa are in Portuguese.
You are right, there´s no official english information from Anvisa on brazilian medical devices regulations.

Are there US based inspectors that can do this inspection at a more reasonable cost than $20,000 if this truely is something we're going to need to do?
No, the inspection has to be done by Anvisa.
 
M

MIREGMGR

#29
I reckon the company for which I work isn't the only one that has looked at the market barriers and decided that, for the foreseeable future, our products just won't go into Brazil.

As we're a long-time, key supplier of disposables and accessories for several Tier 1 global makers of medical imaging equipment, that's likely to be both disruptive for our customers and disadvantageous for Brazilian doctors and patients, but we just can't justify the regulatory hassle-factor required to support the Brazilian market when there are many other markets with harmonized regulatory systems that are eager for greater access to our products.
 

Marcelo

Inactive Registered Visitor
#30
I reckon the company for which I work isn't the only one that has looked at the market barriers and decided that, for the foreseeable future, our products just won't go into Brazil.

As we're a long-time, key supplier of disposables and accessories for several Tier 1 global makers of medical imaging equipment, that's likely to be both disruptive for our customers and disadvantageous for Brazilian doctors and patients, but we just can't justify the regulatory hassle-factor required to support the Brazilian market when there are many other markets with harmonized regulatory systems that are eager for greater access to our products.
You are so true, and it´s my main worry that more of the medical device innovations won´t arrive in Brazil because of this (i mean more because we were always behind before, but with these new regs things might have sky-rocketed).
 
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