Brazil(ANVISA)

서브 비주얼

Latin America

Brazil(INMETRO) Brazil(ANVISA) Mexico Chile Argentina Uruguay Colombia

ANVISA (medical device/cosmetics)

ANVISA (Brazilian Ministry of Food and Drug Safety Inspection): Institution for the approval and monitoring of medical devices, medical supplies, and cosmetics, under the Brazilian Ministry of Health and Safety

Area of Action

Food, Cosmetics, Sanitizing Products, Tabacco, Toxicology(Pesticides), Halth Services, Drugs, Medical Devices, Laboratorles, Blood and blood Products, Post-market Survaillance, Marketing Control, Ports, airports and Frontiers, International, Market Regulation

Registration Procedure

의료기기 등록 절차 순서도

1. Check Brazilian medical device classification
2. Check the requisite for Brazilian GMP evaluation
3. Check the requisite for INMETRO certification
4. Brazilian registration holder donation
5. Forward Brazilian registration holder power of attorney
6. Technical document preparation, and send translated copy, legal document, and indications
7. Submission of Brazilian registration holder ANVISA application form (Portuguese, administrative fees)
8. ANVISA registration document review and issue registration number (DOU)
9. Market entry

Classification of Brazilian Medical Devices

Similar to Europe CE and Korean medical device classification, classified according to potential threat to the human body

브라질 의료기기 등급에 따른 예시와 등록방법
Classification		Example	How to Register
I	Low Risk	Majority of non-invasive products	Cadastro
II	Medium Risk	Non-invasive blood container, short contact invasive products and diagnostic device	Cadastro/Registro
III	High Risk	Majority of invasive products and majority of electronic products	Registro
IV	Maximum Risk	Majority of products related to transplant submission of organs	Registro

INMETRO Certification

- Mandatorily applicable for electronic medical device, injection needle, syringe, blood container, some measuring devices and breast implant
- Certification process (test and evaluation) performed by INMETRO certified
- Certification of ILAC institution test result (within 2 years)
- Valid for 5 years, mandatory annual renewal

Brazil GMP

- Similar to ISO 13485 and the Korean GMP regulation
- GMP evaluation mandatory for class 3, 4 medical device manufacturing factory
- Not mandatory for class 1, 2; INMETRO certification only
- Valid for 5 years (renewal mandatory prior to 12 months before expiry)

BRH, Brazilian Registration Holder

- Appointment necessary if no branch within the area in Brazil
- Legal owner of the Brazilian registration; in charge of communication with ANVISA for the product of the manufacturer

KTR Support

- Support ANVISA duties and offer the latest regulation trend
- Check Brazilian medical device classification
- Check requisite for INMETRO certification and support certification
- Discover appropriate partner in Brazil and offer the optimal advancement strategy
- · Consulting agency
- · BRH
- · Importer/Distributor
- Offer various consulting

ANVISA Cosmetics Registration Summary

In order to sell perfume, cosmetics, toiletry and other such products in Brazil, registration is mandatory with Brazil Ministry of Health (ANVISA) that controls the importation and exportation of cosmetics, perfume, toiletry, food, medicine, medical device, etc.

Cosmetics Classification

Cosmetics are classified into two groups according to user hazard; grade 1, Produtos Cosmeticos Grau 1 and grade 2, Produtos Cosmeticos Grau 2.

Grade 1

- Products of which the primal, basic properties are already proven. These do not require detailed instruction on usage and caution, and do not require ANVISA registration.
- Report Free Sales Permit, data on physiochemical properties, ingredient information, and microbial information on the ANVISA website.

Grade 2

- Products with specific effect and purpose that requires proof of safety and effectiveness.
- Requires instruction on usage and caution, as well as ANVISA registration.
- However, due to the regulation of simplifying cosmetic registration (DRC07/2015) declared in February of 2015 by the Brazilian government, a majority of degree 2 cosmetics are excluded from the requisite, with the exception of sunscreen, insecticide, tanning products, children's products, alcohol gel products, hair straightener, etc.

Certification Process

1. Register online on the ANVISA website after obtaining approval of the free sales permit and product certificate through the Brazilian embassy consul in Korea
- - Grade 1 products: Immediate import and distribution allowed, once submitting the documents including the basic information of the products (product component information, physiochemical information, microbial information, free sales certificate, etc.), and the report form.
- - Grade 2 products: Institution reviews and responds after submitting the documents, and will be handled according to the results
2. ANVISA electronically monitors the products and cancels upon the discovery of any product or classification error; ANVISA and GGCOS (Overall Cosmetics Administrative Institution) only monitors electronically without a prior review.
3. Report Importation (report to the federal taxation bureau if a local importer clears local customs)
4. Sell after clearing the customs

KTR Service

Offers a one-stop service from classification to reporting of the product

Point of contact

담당자 - Name, Tel, E-mail
Name	Position	Task	Tel	E-mail
Park Jinjae	Manager	KC, CB, CCC, CE etc Global Certificate	+82-2-2164-1479	jjpark@ktr.or.kr