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G/TBT/N/BRA/328 Health Products

Reply from Brazil dated 14 June 2010

RESPONSE TO THE EUROPEAN COMMUNITY

The requirement to prove compliance with Good Manufacturing Practices (GMP) for

medical products was not instituted by RDC No 25/2009. That Resolution solely

standardised the periods for the entry into force of RDC No 59/2000, which lays down the

GMP requirements adopted. RDC No 59/2000, in turn, followed on from the transposition of

MERCOSUR regulations dating from 1995, which are requirements harmonised among the

Member States (Brazil, Argentina, Uruguay and Paraguay), as laid down and agreed by

MERCOSUR Resolutions MERCOSUR/GMC/Res. No 04/1995 and Mercosur/GMC/Res. No

131/1996. These therefore represent a commitment not only by Brazil but by the entire

MERCOSUR economic bloc. In this context Brazil has had the GMP requirements defined

for medical products in place since 1995, although these were not stipulated to the full extentnecessary due to an operational issue within Anvisa which has now been overcome. We

emphasise that the drafting and definition of these requirements, both within MERCOSUR

and within Brazil, was open to participation by Brazilian and foreign enterprises, including

European enterprises represented by their subsidiaries and importers in Brazil, in the

process of public consultations and participation by representatives in MERCOSUR

meetings. The process was therefore clear and transparent for all concerned.

We would further make it clear that Brazil's acceptance of instruments for assessing

good manufacturing practices remains unchanged with the move from ISO 13485 to RDC

No 59/2000. Brazil does not have any valid or repealed legislation providing for the adoption

of ISO 13485 certification as evidence of compliance with good manufacturing practices formedical products. Since 1995 the valid requirements have been those agreed within

MERCOSUR, duly adopted in 2000 with the publication of RDC No 59/2000.

According to indent X of Article 3 of Decree 3.029 of 16 April 1999, Anvisa is

responsible for issuing and revoking certificates of compliance with good manufacturing

practices. Anvisa may not delegate this activity, given that it is not cited as one of the

activities that may be delegated in Article 3(2) of the above-mentioned decree. Furthermore,

that article itself solely permits Anvisa to delegate powers to States, Municipalities, the

Federal District or the Ministry of Health. Brazilian law does not therefore permit the task of

certifying good manufacturing practices requiring medical surveillance to be delegated to

institutions for the certification of products/systems (Notify(sic) Bodies), so that it would atpresent not be possible to accept a certificate on the basis of ISO 13485 or any regulation

other than RDC No 59/2000 issued by a public or private Brazilian or foreign institution other

than Anvisa.

Pursuant to Law No 6360/76, regulated by Decree No 79.094 of 05 January 1977,

laying down the general requirements for the regulation of products requiring medical

surveillance, a certificate of compliance with Good Manufacturing Practices in accordance

with indent X of Article 17 of Decree No 79.094/77 (as amended by Decree 3.961 of

10 October 2001) must be submitted when applying for product registration. The actual

definition of the certification of compliance with Good Manufacturing Practices emphasises

that this is a document issued by the Federal Health Authority declaring that the licensedestablishment complies with the Good Manufacturing and Control requirements. The

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certificate submitted must thus be issued by the Federal Health Authority, and it is not

possible to accept a certificate issued by any other body.

Brazil's specific regulation of Good Manufacturing Practices for medical devices was

published by RDC No 59 of 27 June 2000 and since then it has gone through a period of

gradual adaptation until it became mandatory in full in May 2010 with the entry into force of

RDC No 25/2009. From 2000 to 2010 Brazil slowly incorporated the adoption of the

requirements concerned, first applying them to Brazilian enterprises and now extending their

scope to foreign enterprises. This regulation may therefore not be seen as a technical barrier

to foreign products, given that the same requirements apply to the domestic industry. Neither

may it be considered unknown to foreign manufacturers, given that it was published 10 years

ago and Anvisa has made the requirements adopted over the years fully public without any

restriction, including bringing them to the attention of the subsidiaries of foreign enterprises

in Brazil and to importers as a whole, and thus also to the representatives of foreign

enterprises in this country.

Furthermore all the requirements laid down by RDC No 59/2000 are based on the

requirements adopted by the USA in Part 820 Quality System Regulation of the Code ofFederal Regulation Food and Drugs. These requirements are not unfounded or

unattainable, much less at odds with the requirements laid down in ISO 13485. Enterprises

with a quality system based on ISO 13485 do not need to duplicate their quality system to

comply with RDC No 59/2000 because both may be structured within a single quality

system, as is the case of enterprises which observe ISO 13485 and the American FDA's

Quality System Regulation - QSR.

The Global Harmonization Task Force (DHTF), of which the European Community is

a member does not put ISO 13485 forward as the sole instrument to be adopted for

assessing Good Manufacturing Practices in its guides. Even among countries like the USA,

Japan, the EC, Canada and Australia there is no consensus on the adoption of ISO 13485as the sole, universal mechanism for assessing GMP, and this practice is not exclusive to

Brazil among the countries that are members of the World Trade Organization (WTO) and

also signatories to the TBT Agreement. The USA also has its own requirements for

assessing the quality systems of manufacturers of medical products. So has Canada, which,

although it has adopted ISO 13485, supplements its requirements with its own ones.

In technical terms the two instruments - ISO 13485 and RDC No 59/2000 do not

conflict, and complying with one is no obstacle to compliance with the other although they

have their little differences. The main difference between these two instruments is in their

focus, in that ISO 13485 takes a macro approach to the client's requirements while RDC No

59/2000 focuses on guaranteeing the quality of the process and controlling risk factors toconsumer health. In mature consumer markets with ample access to information and well

developed critical awareness it is observed that the client's requirements tend to converge

on the objectives provided for in RDC No 59/2000. This explains the fact that some

enterprises, although ISO 13485 certified, do not comply with all the requirements of RDC

No 59/2000. This is no proof of the superiority or greater rigidity of one instrument in relation

to the other, only of the level of maturity of the consumer markets on which these enterprises

operate.

The European Community uses ISO 13485 in its regulatory requirements, albeit not

in isolation. The annexes to Directive 93/42 lay down different combinations, according to

the kind of risk and the product characteristics, of ISO 13485 certification, type testing, proofof compliance with safety and efficacy requirements, evaluation of projects, clinical trials and

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declaratory models. To some extent these combination models minimise the isolated effect

of focussing on the client's requirements, and any extra checks necessary are guaranteed

by other means. Moreover, the European Community has a very well articulated and

structured post-market surveillance system that makes it possible to identify adverse events

and technical complaints in good time so that corrective and preventive action can be taken.

The reality in Brazil is different, the regulatory model differs from the European model

and its checks differ, too. We are beginning to structure our post-market checking and we

hope to have a robust, effective model soon. Brazil's regulatory structure and technical

requirements are different from Europe's, although they are similar at some points, which

does not make them better or worse; they just differ in terms of the characteristics of the

market and the Brazilian legal framework.

In addition to these facts, in the context of the multilateral acceptance of certificates,

there is still no official regulation within the International Accreditation Forum (IAF) for the

multilateral recognition of certification between bodies accredited by the institutions that are

signatories to that forum in respect of ISO 13485 (N.B. Brazil is represented by INMETRO in

the IAF). There is therefore as yet no possibility for the mutual recognition of certificationbased on ISO 13485 between countries, at least not on the lines of multilateral recognition of

the other system certification models that exist (e.g. ISO 9000).

It is emphasised that adapting the instrument currently adopted to ISO 13485 does

not simply imply modifying a criterion relating to GMP, but modifying a whole regulatory,

legal and legislative structure so as to guarantee that all the checks provided for currently

remain in place. It is not possible to look at a system for regulating medical devices, in any

country, and to focus solely on one point in isolation; it needs to be approached systemically,

understanding that it is made up of processes of pre-market approval, post-market

monitoring and GMP certification/inspection while taking every country's market

characteristics and legal and legislative model into consideration. At every stage it isnecessary to understand the control mechanisms that exist and how the interaction between

the stages takes place. As the model is systemic, changes also have to be systemic, or at

least their impact has to be assessed systemically.

Brazil agrees that there is a need to look at the criteria for mutual recognition of

certification, whatever instrument may be adopted or chosen. The main challenge does not

lie in the doubling of requirements, given that those we have today are in a certain way

harmonious, but in the doubling of action in relation to the same requirements. Brazil is

prepared to discuss recognition, provided that it is mutual recognition between countries and

not merely unilateral recognition by Brazil.