Medical Device Registration Process in Brazil - Anvisa (Part 3)

tibon74

Quite Involved in Discussions
#3
Hello everybody,

For european manufacturers, I would like to know if the medical devices must be previously approved in the origin country (Europe) to be approved in Brazil or is it enough to be approved in another country (USA for exemple) ?

thanks !
 

recruit

Inactive Registered Visitor
#4
For medical device under IEC60601-1, Inmetro certificate can be used without approval in origin country. For other medical device, the approval in another country can be used. But for reagents, only approval in origin country is accetpable.
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#5
For european manufacturers, I would like to know if the medical devices must be previously approved in the origin country (Europe) to be approved in Brazil or is it enough to be approved in another country (USA for exemple) ?
It has to be the "legal manufacturer" (although this figure do not exist in practice for Brazilian manufacturers), so yes, you can manufacture in one country and have the free sales of another. But it seems in your case the legal manufacturer is the European one, right?
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#6
Just a general update on GMP and registration....CP 50 has been published to revise RDC 25. The text proposes that the exemption list for cadastre be revoked (meaning that all class I and II devices will only be cadastre), and permits the beginning of the registration process with the inspection protocol (which was already being done). However, the registration itself still needs the certificate.

It also has a clause on accepting of third party audit reports to enable ANVISA to use reports form the MDSAP program.
 

recruit

Inactive Registered Visitor
#7
Hi Marcelo, That's exciting news. :applause:
Is CP 50 draft or effective? Could you share the original regulation or relevant link?
 

tibon74

Quite Involved in Discussions
#9
Hi Marcelo,

Yes the legal manufacturer is in Europe.
By the way, when should a subcontractor be inspected by ANVISA?
With Single Audit Program, can an only one inspection of a subcontractor be enough for several manufacturers ?
thanks !
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#10
Yes, Taieb is right, CP 50 is still a draft (my bad, should have explained that CP means Public Consultation in portuguese).

The original document in Portuguese is attached. I?ve translated it below.

RESOLU??O DA DIRETORIA COLEGIADA - RDC No xx, DE xx DE xx DE 2013.

Establishes the requirements for proof of compliance with Good Manufacturing Practices for registration of Medical Devices and other measures.

The Board of the National Health Surveillance Agency, in exercise of the powers granted by art. 11, item IV of the ANVISA Regulation approved by Decree No. 3029 of April 16, 1999, and in view of the provisions of paragraphs 1 and 3 of article. 54 and in item II of art. 55 of the Bylaws approved in accordance with Annex I of Ordinance No. 354 of ANVISA, of August 11, 2006, republished in the Official Gazette of August 21, 2006, at a meeting held on xx xx 2013, resolves:

Article 1 ? This resolution defines the requirements for proof of compliance with Good Manufacturing Practices - GMP required for registration of medical devices.

Article 2 The protocol of the application for certification of Good Manufacturing Practices will be accepted for the purpose of petitioning and to start the analysis of petitions to grant registration, revalidation of registration, amendment / inclusion of manufacturer, all related to medical devices under classes III and IV.

? 1 The granting of requests for registration and amendment / inclusion of manufacturer as caput, is conditional upon presentation of the a valid certificate of Good Manufacturing Practices issued by ANVISA and the fulfillment of other requirements for registration of health products.

? 2 The granting of requests for revalidation of registration, as caput give will be through evaluation of historical data of deviations, technical complaints and adverse events (Technovigillance) and / or sanitary violations documented by the competent authorities, relating to the product registration.

Art. 3. Article 4 of the Board Resolution - RDC N ? 39, August 14th 2013 shall henceforth read as follows:

"Art 4th .............

Single paragraph. The grant of approval of the caput of this article may occur upon presentation of a valid audit report, issued by a third party auditing organization, according to specific programs, both recognized by ANVISA.

Article 4 The provisions of this Resolution shall not exempt the manufacturers and importers of the obligation to ensure that medical devices marketed by them, regardless of their risk class, have been produced and distributed in compliance with the the applicable standards of Good Manufacturing Practices issued by ANVISA.

Article 5 Revokes RDC. 25 of 21 May 2009 and Normative Instruction. 02 of May 31, 2011.

Article 6 This Resolution shall enter into force on the date of its publication.
 

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