Heather:
Here we go! I believe this (see below translated in English) is good enough to know the contents of the Draft Resolution Number CP 62, Dated 12/15/2011, and issued by the ANVISA.
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National Agency of Sanitary Surveillance
www.anvisa.gov.br
Public Consultation No. 62, December 15, 2011
D.O.U for 19/12/2011
The Board of the National Sanitary Surveillance Agency, in exercise of the powers conferred upon her by item IV of article. 11 of the ANVISA Regulation approved by Decree n. 3.029, of April 16, 1999, c / c section II, and § § 1 and 3 of art. 54 of the Bylaws approved by Decree n. 354 of ANVISA, in August 11, 2006, republished on August 21, 2006 meeting held on December 12, 2011, adopts the following Draft and I, Chief Executive Officer, determine its publication:
Article 1 shall be open, from the date of publication of this public consultation, the period of 45 (forty five) days for comments and suggestions are made regarding the proposed resolution that "sets criteria for optimization of inspection missions to international verification of compliance with Good Manufacturing Practices for Medical Products and Products for Use In Vitro Diagnostic and other measures ", in Annex.
Article 2 Inform the proposed resolution is available in full on the Internet site of the ANVISA and suggestions should be submitted in writing, in proper form to the following address: National Agency of Sanitary Vigilance - CPROD / GGIMP, SIA Excerpt 5, Area 57 Special, Brasilia-DF, CEP 71205-050, or Fax: (61) 3462-5837, or e-mail: @ cp62.2011 anvisa.gov.br.
§ 1 The object of this public consultation documents and the form for submission of contributions will remain available to interested parties at http://www.anvisa.gov.br/divulga/consulta/index.htm.
§ 2 The contributions received will be public and will remain available to all in the ANVISA website on the Internet.
§ 3 The contributions are not sent in the form mentioned in the previous paragraph or received after the deadline will not be considered for final wording of the regulation.
Article 3 After the deadline stipulated in art. 1 to the National Agency of Sanitary Surveillance can link up with the agencies and entities involved and those who have expressed an interest in the matter, that appoint representatives in the subsequent discussions the final wording.
Sole Paragraph. The final wording of the Regulation and Analysis Report Contributions will be made available on the Internet Anvisa after the deliberation of the Board.
DIRCEU BRÁS APARECIDO Barbano
ANNEX
Board Resolution - RDC No. XX of XXXXX 2011
Sets criteria for optimization of the missions of international inspection for verification of compliance with Good Manufacturing Practices for Medical Products and Products for Use In Vitro Diagnostic and other measures.
The Board of the National Sanitary Surveillance Agency, in exercise of the powers conferred upon her by item IV of article. 11 of the Regulation approved by Decree No. 3029 of April 16, 1999, and in view of the provisions of section II and in § 1 and § 3 of art. 54 of the Bylaws approved in accordance with Annex I of Ordinance No. 354 of ANVISA, in August 11, 2006, republished in the DOU of 21 August 2006,
At a meeting held December 12, 2011, adopts the following Board Resolution and I, the Chairman, determine its publication:
Article 1 is hereby approved the methodology for scheduling international inspection for verification of compliance with Good Manufacturing Practices for Medical Products and Products for In Vitro Diagnostic Use, including criteria for prioritizing inspections for verification of Practice mentioned.
Section 2 This resolution applies to applications filed with the ANVISA certification of Good Manufacturing Practices for Medical Products and Products for In Vitro Diagnostic Use in factories located abroad.
CHAPTER I
DEFINITIONS
3 For purposes of this technical regulation, adopted the following definitions:
I - quality documentation: documents concerning the company's quality system to be inspected, for the preparation of sanitary inspection;
II - Reference plant: plant to be inspected, according to the chronological order of application, used as a parameter to the scheduling of inspections related plants, and
III - linked plant: plant whose location, accessibility or mission time scheduling justify their inspection in use of the proposed assignment for the reference plant.
CHAPTER II
THE METHODOLOGY OF SCHEDULE
Article 4 The scheduling of inspections in the manufacturing units of reference will be made considering the chronological order of application for certification of Good Manufacturing Practices for Medical Products and Products for In Vitro Diagnostic Use at ANVISA.
Sole Paragraph. In the certification requirements of Good Manufacturing Practices for Medical Products and Products for In Vitro Diagnostic Use that result in notification requirement, the date to be considered for scheduling the inspection protocol will be the documentation of compliance with the notification .
Article 5 The inspection schedules in plants bind the reference service of the concomitant requirements relating to inspection in the same factory and the factories linked.
§ 1 The care co referred to in the caption is subject to the operational limit of the inspection team assigned to the mission.
Article 6 For the purposes of identifying plants bound consider the following criteria:
I - performed the inspection of the manufacturing facility of reference, there is the possibility of carrying out inspection on at least one plant within the first 5 (five) working days of the mission;
II - carried out the inspection of the manufacturing facility of reference, there is the possibility of carrying out inspection in at least two more plants within 10 (ten) working days of the mission;
III - the linked plant is located within 200 (two hundred) kilometers of the reference plant, with travel time not exceeding 3 (three) hours, or
IV - the reference plant is located in countries where travel time in relation to Brazil more than 24 (twenty four) hours.
§ 1 The verification of the time needed to conduct inspections shall be made in advance through quality documentation submitted to ANVISA, the time the request for certification of Good Manufacturing Practices for Medical Products and Products for Diagnostic Use In Vitro.
§ 2 In the certification requirements of Good Manufacturing Practices for Medical Products and Products for In Vitro Diagnostic Use filed before the effective date of this resolution, the quality documentation must be submitted by means of an addition.
§ 3 The quality of the documentation referred to in § 1 shall be defined in Instruction.
§ 4 The definition of related plants to be inspected will be made according to their chronological order of application protocol inspection by ANVISA or fulfillment of reporting requirements, as appropriate.
CHAPTER III
CRITERIA FOR INSPECTIONS PRORIZAÇÃO
Article 7 The inspections to verify compliance with the requirements of Good Manufacturing Practices for Medical Products and Products for In Vitro Diagnostic Use may be anticipated, regardless of the methodology for scheduling in this Resolution, upon request of interested companies from who attended at least one of the following requirements:
I - the completion of the inspection is necessary to change the place of manufacture of products unmatched in the domestic market in order to avoid shortages;
II - to conduct the inspection is necessary for the viability of importing, manufacturing or marketing of products identified as priorities by the Ministry of Health, which are the subject of:
a) strategic actions concerning the health of the population, or
b) projects or processes of technological development with funding from government agencies, or in fostering partnerships involving government agencies;
III - request inspection requirement originated from dissolution of records or registrations of health products;
IV - Inspection requirements concerning products that are complementary to others who are in the process of analysis, or
V - inspection requirements on the same subject, made by the same person and that can be processed together.
§ 1 An indication of the priority products, pursuant to section II of this article, please observe proper act of the Ministry of Health, detailing the motivation in each case.
§ 2 The requirements for prioritization of inspection should be forwarded to the General Office of Inspection and Control of Supplies, Medicines and ANVISA.
§ 3 In the case of prioritizing certain inspection, factory to be inspected will be considered a reference plant for the purposes of this Resolution.
Article 8 This Resolution shall be effective on the date of its publication.
DIRCEU BRÁS APARECIDO Barbano
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David
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www.regulatorydoctor.com Floyd VA
United States
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Original Message:
Sent: 03-13-2012 10:49
From: Heather Neely
Subject: Medical Device Registration in Brazil
Is the draft resolution to address the timeliness of GMP Inspections scheduling (CP 62, December 2011, also via WTO G/TBT/N/BRA/454) available in English? If so, where can it be located. I have only been able to find it in Portuguese.
Heather Neely RAC
Oxnard CA
United States
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Original Message:
Sent: 03-12-2012 09:00
From: Raymond Seda
Subject: Medical Device Registration in Brazil
Yes, certification is required for registration.
The are certain device classifications (e.g. Class I/II) that are exempt from the organic registration route and GMP certification is not required (e.g. devices subject to "cadastro", similar to a device-listing with very few documents required for registration).
Certification itself is not that difficult as the inspection process is similar to ISO/FDA audit (desk audit and walkthroughs) - the main issue is scheduling. Anvisa is taking almost 2 years to arrange a site inspection. This means, that commercializing of a device (Class III,IV and certain IVDs) can take up to 3 years to be cleared (2 years GMP cert, ~18 month registration clearance); which is all detrimental to provide access to innovative technologies and of high quality/tech devices to the Brazilian population.
Please note Anvisa has published a draft resolution to address the timeliness of GMP Inspections scheduling (CP 62, December 2011, also via WTO G/TBT/N/BRA/454) - there are some considerations that may expedite the scheduling, such as: if there is no equivalent/similar device in the local market, if the device is considered as "priority" by the Ministry of Health, if device is complementary to another device in the market or under Anvisa review. Further, there are other requirements relative to the distance/time between manufacturing facilities - Anvisa may inspect more than one facility if the location is within 200km/3hrs distance. I believe this applies if you have nearby facilities for a device(s) to be registered or if Anvisa has an established inspection schedule within these parameters for another company to be inspected.
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Raymond Seda MBA, RAC
Associate Director, Regulatory Affairs
Zimmer Inc - Latin Ameirca
Original Message:
Sent: 03-11-2012 13:02
From: John Minier
Subject: Medical Device Registration in Brazil
We have registered products with Brazil without an audit. The amount of detail they want is immense as they are not part of the Hague Treaty. This becomes a problem when a process or raw material like NuSil has a technical file on file with the FDA that we cannot supply to Brazil. We have to rely on material testing only, so the testing has to be to a specific standard and all the data from the testing has to be supplied.
We suspect part of the hurdles to registration may be Brazil protecting home industry as technology they could not easily reproduce locally is approved much quicker than less technical devices.
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John Minier
Small Bone Innovations, Inc
Morrisville PA
United States
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Original Message:
Sent: 03-09-2012 09:47
From: Al Van Houdt
Subject: Medical Device Registration in Brazil
Like many others, we are trying to get an ANVISA audit of our facility. Pending this audit, is Brazil denying new product registration?
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Al Van Houdt
Dir RA/QA
Spacelabs Medical, Inc
Issaquah WA
United States
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