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1.

Notifying Member: Brazil

If applicable, name of local government involved (Article 3.2 and 7.2):  

2.

Agency responsible: Brazilian Health Surveillance Agency – Anvisa

Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:

National Institute of Metrology, Quality and Technology – INMETRO

Telephone: +(55) 21 2563.2840

Telefax: +(55) 21 2563.5637

Email: barreirastecnicas@inmetro.gov.br

Web-site: http://www.inmetro.gov.br/barreirastecnicas

The comments to this Draft Regulation shall be sent to

http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=21796

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:

4.

Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Implantable products which are used in procedures of permanent artificial pigmentation on skin.

5.

Title, number of pages and language(s) of the notified document: Draft Technical Resolution no 61, August 17th 2015, regarding the changing of safety and efficacy requirements to registering implantable products which are used in procedures of permanent artificial pigmentation on skin. (3 pages, in Portuguese).

6.

Description of content: Draft Technical Resolution no 61, August 17th 2015, regarding the changing of safety and efficacy requirements to registering implantable products which are used in procedures of permanent artificial pigmentation on skin.

This Draft Technical Resolution modifies the item 5.2 of Part 5 of the Annex of Resolution RDC 55/2008.

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of Human health or Safety

8.

Relevant documents: 1) Brazilian Official Journal (Diário Oficial da Uni?o), August 18th 2015; Section 1, p. 33; 2) RDC 55/2008; 3) Brazilian Official Journal; 4) Not Stated.

9.

Proposed date of adoption: To be determined after the end of the consultation period.

Proposed date of entry into force: On the date of the publication.

10.

Final date for comments: 23 October 2015

11.

Texts available from: National enquiry point [X] or address, telephone and fax numbers and email and website addresses, if available, of other body:

Agency Responsible

Brazilian Health Surveillance Agency – Anvisa

SIA, Trecho 5, área Especial 57

Brasília – DF/Brazil

CEP: 71.205-050

Phone: +(55) 61 3462.5402

Website: www.anvisa.gov.br

http://portal.anvisa.gov.br/wps/wcm/connect/2d98aa80498640d4bd7ebfda875a0177/CP+61-2015+-+Minuta.pdf?MOD=AJPERES