National Health Surveillance Agency  
www.anvisa.gov.br  
Public Consultation No 6 of 18  January  2012.  
Brazilian Official Journal of 19  January 2012  
The Board of the National Health Surveillance Agency (ANVISA), in the exercise of the 
powers granted by Artic le 11(IV) and Article 35 of ANVISA’s Regulations, approved by 
Decree No. 3029 of 16 April 1999, and having regard to the provisions of Article 54, indent 
(V) and paragraphs (1) and (3) of the Internal Regulations approved in accordance with 
Annex I to ANVI SA Administrative Ruling No. 354 of 11 August 2006, republished in the 
Brazilian Official Journal of 21 August 2006, at a meeting held on 17 January 2012, hereby 
adopts the following Public Consultation and I, the Chief Executive Officer, order its 
publica tion. 
Article 1. Criticisms and suggestions concerning the attached draft Resolution on the 
minimum identity and quality requirements for breast implants and certification requirements 
of the product in the Sistema Brasileiro de Avaliação da Conformidade  – SBAC ( Brazilian 
System of Evaluation and Conformity)  may be submitted up to 30 (thirty) days from the date 
of publication of this Public Consultation.  
Article 2. The full text of the draft Resolution is available on ANVISA’s website. Suggestions 
should be  submitted in writing, using the dedicated form, to one of the following: Agência 
Nacional de Vigilância Sanitária/GIMEP/GGIMP, SIA Trecho 5, Área Especial 57, Brasília - 
DF, CEP 71.205 -050; or by fax to: (61) 3462 -6644; or by email to: cp06.2010@anvisa.gov .br. 
§1. The documentation to which this Public Consultation relates and the form for submission 
of contributions will be available to interested parties at the internet address 
http://www.anvisa.gov.br/divulga/consulta/index.htm.  
§2. The contributions rec eived will be public, and will remain available to all on ANVISA’s 
website.  
§3. Contributions not sent using the abovementioned form or received outside the period will 
not be taken into consideration in the consolidation of the final text of the regulatio n. 
Article 3. At the end of the period mentioned in Article 1, the Agency will contact the bodies 
and entities involved and others who have expressed an interest in the matter so that they may 
designate representatives for subsequent discussions geared tow ards the consolidation of the 
final text.  
Sole paragraph. The consolidation of the final text of the regulation and the Report on the 
Analysis of the Contributions will be available on ANVISA’s website after the Board has 
completed its discussions.  
DIRCEU BRÁS APARECIDO BARBANO  
ANNEX  DRAFT RESOLUTION FOR PUBLIC CONSULTATION  
COLLEGIATE DIRECTORATE RESOLUTION (RDC) No … of … [date] 2011  
Lays down the minimum identity and quality requirements for breast implants and 
certification requirements of the product in  the SBAC.  The Board of the National Health 
Surveillance Agency, in the exercise of the powers granted by Article 11(IV) of the 
Regulation approved by Decree No  3029 of 16 April 1999, and having regard to the 
provisions of indent (II) and paragraphs (1) an d (3) of Article 54 of the Internal Regulations 
approved in accordance with Annex I of ANVISA Administrative Ruling No  354 of 11 
August 2006, republished in the Official Gazette of 21 August 2006, at a meeting held on 
[date] 2011, hereby adopts the followi ng Collegiate Board Resolution and I, the Chief 
Executive Officer, order its publication:  
Article 1. The technical regulation laying down minimum identity and quality requirements 
for breast implants is hereby approved.  
CHAPTER I - GENERAL PROVISIONS  
Secti on I – Objective and Scope  
Article 2 – This Resolution lays down the minimum identity and quality requirements for 
breast implants and certification requirements of the product in the SBAC.  
Section II - Definitions  
Article 3 – For the purposes of this Tech nical Regulation the following definitions are hereby 
adopted:  
I – BREAST IMPLANT: Implant with a membrane filled by the manufacturer or surgeon 
intended to add to or replace breast volume.  
II – SEAL OR CLOSURE: connection of materials melted or stuck toge ther. 
III – VALVE: Component into which a device is inserted to inflate variable -volume implants.  
IV – INJECTION POINT: Component to be punctured by a needle in order to change the 
volume of the implant.  
V – MEMBRANE – envelope containing the implant.  
VI – TRACEABILITY LABEL: additional document to be supplied with health -related 
material, containing a field in which to put the following information: a) commercial name or 
model; b) manufacturer or importer's name; c) code of the product or system component;  and 
d) batch number and ANVISA registration number.  
Section III – Implant classification  
Article 4 – Breast implants are classified according to:  
I – raw material of the membrane: a) silicone; or b) polyurethane.  II – type of filling: a) Type 1: Single lu men containing saline solution; b) Type 2: Single 
lumen for filling with saline solution during the operation; c) Type 3: Single lumen for filling 
with saline solution with the possibility of volume adjustment after the operation; d) Type 4: 
Single lumen c ontaining silicone gel; e) Type 5: Double lumen – one containing silicone gel 
and the second for filling with saline solution during the operation; or f) Type 6:  Double 
lumen – one containing silicone gel and the second for filling with saline solution wi th the 
possibility of volume adjustment after the operation;  
III – surface: a) smooth; or b) textured.  
Section IV – Implant Designation  
 
Article 5 – The designation of the products covered by this Resolution must bear the words 
BREAST IMPLANT followed by the wording corresponding to the classifications under 
Article  4. 
Section V – Conformity Certificate  
Article 6 – In addition to the requirements laid down in this Resolution, breast implants must 
also meet the conformity certification requirements laid dow n by the SBAC.  
§1. Brazilian manufacturers and importers may opt for certification either via a Quality 
Management System assessment of the production process and product testing or assessment 
on a batch -by-batch basis.  
§2. When applying for registration a nd for the revalidation of certificates, companies must 
submit a valid copy of the conformity certificate or batch release in respect of each implant 
model, as applicable.  
CHAPTER II – TECHNICAL REGULATION  
Section I – General principles  
Article 7. Breast i mplants are single -use products, which may not be reprocessed.  
Article 8. Breast implants must be free of contaminants that may pose a risk to human health 
and must undergo a biosafety assessment.  
Article 9. Breast implants must be supplied sterile.  
Articl e 10. Breast implants must bear markings containing:  
I – manufacturer's name or trade mark;  
II – nominal volume or size of implant; and III – batch or serial number.  
Article 11. Manufacturers of breast implants must have implemented the Boas Práticas de 
Fabricação  – BPF (Good Manufacturing Practices).  Article 12. The biosafety of any substance inserted into the body by means of breast implants 
must be assessed by the manufacturer in conformity with ISO  10993 -1 or any standard that 
may replace this in future . 
Article 13. Manufacturers of breast implants must meet the minimum quality requirements 
according to the testing, procedures and methods described in ISO 14607:2007 or any 
standard that may replace this in future.  
Article 14. The manufacturer or importer  must provide traceability labels with the product 
bearing the name of the implant.  
Sole paragraph. At least three traceability labels must be provided and attached to the clinical 
records, the document to be issued to the patient and the tax documentation  governing 
payment.  
Section II – Minimum Requirements  
Article 15. Breast implants must meet the requirements laid down in ISO  14607:2007, or any 
standard that may replace this in future, as regards the following performance requirements: I 
- Integrity of t he Membrane Material: a) Elongation test; b) Stress point; c) tear resistance; 
and d) resistance of the seal or closure.  
II – Cohesion test of the silicone gel;  
III – Mechanical testing for breast implants at the implantable stage: a) wear test; and b) 
impact test.  
IV – In respect of variable -volume implants, tests for effectiveness of the valve and the 
injection point;  
V – Biological tests: a) cytotoxicity; and b) biodegradation.  
Article 16. The silicone elastomers used in the manufacture of breast implant s must meet the 
requirements laid down in Standard NF S99 -401:1994 or any standard that may replace this in 
future.  
Section III – Packaging and Labelling  
Article 17. Breast implants must be packaged in single packaging.  
Article 18. The packaging of breast implants must ensure the integrity of the products, 
especially as regards maintaining the sterility of the contents.  
Article 19. Single packages of breast implants must [once opened] present clear evidence that 
they have been opened and must not be re -sealable after opening.  
Article 20. The wording on the labelling of breast implants must meet the requirements laid 
down in the Brazilian and international regulations and technical standards referred to in this 
Resolution.  
Section IV – Instructions  Article 21 . The instructions for breast implants must contain the following information for the 
user:  
I – indications for the operation;  
II – description of the implant;  
III – instructions;  
IV – contra -indications;  
V – potential complications of the operation and wa ys of remedying those complications;  
VI – precautions;  
VII – instructions for the explant;  
VIII – recommendations for post -implant follow -up; 
IX – expectations of the implant's useful life; and  
X – any other information required under the Brazilian and int ernational regulations and 
technical standards referred to in this Resolution.  
Art 22. The information below must be included in the instructions and must be issued to the 
patient in suitable documentation; it must also be explained by the surgeon respons ible prior 
to the operation.  
I – Business name and address of manufacturer/importer;  
II – Complete description of the implant, including the type of implant and the raw material;  
III – The product's expected useful life expressed in accordance with ISO 146 07:2007 or any 
standard that may replace this in future;  
IV – The following warnings: "Breast implants have a limited useful life" and "This implant 
may need to be removed or replaced, which may entail corrective surgery."  
V – Expected benefits;  
VI – Antic ipated risks, including information on local complications such as capsular 
contracture, rupture, leaking, deflation and wrinkling;  
VII – Unwanted effects such as pain, infection, aesthetic problems, changes to the nipples and 
sensitivity in the breast;  
VIII – Possibility of interference in breast feeding;  
IX – Clarification as to the effects of the implant in diagnostic tests such as mammography;  
X – Possible interference of the implant in the self -examination of breasts;  
XI – Clarification of the need for  periodic medical assessment; and  XII – Indication that the patient must seek medical advice if there is any suspicion of 
complication.  
Section V – Sampling  
Article 23 – The sampling plans, inspection levels and levels of acceptable quality applicable 
to breast implants shall be those specified in the conformity assessment regulation.  
Section VI – Packaging and Storage  
Article 24. Breast implants must be packaged in such a way that the product is protected and 
remains intact from its manufacture to its end  use. 
Article 25 Breast implants must be stored and transported under conditions that preserve their 
integrity and protect them from exposure to heat, moisture and light.  
CHAPTER III: FINAL AND TRANSITIONAL PROVISIONS  
Article 26. Failure to comply with the  provisions of this Resolution shall constitute a health 
infraction in accordance with Law No 6437 of 20 August 1977, notwithstanding any civil, 
administrative and criminal liability that may apply.  
Article 27. This Resolution shall enter into force on the  date of its publication.  
DIRCEU BRÁS APARECIDO BARBANO