Brazil’s ANVISA
Medical Device/IVD
Pharmaceuticals
Cosmetics
Food Supplements
Medical Devices
GRP has a global presence with teams of local experts who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your device in Brazil’s markets.
Medical devices are governed by ANVISA, the Agência Nacional de Vigilância Sanitária, under the Brazilian Ministry of Health. ANVISA is an autonomous arm of the government and is responsible for the protection of the public’s health.
Authorized local agent
GRP-Brazil: Your Local Representative for ANVISA Compliance
The Brazilian Health Regulatory Agency (ANVISA) requires that foreign medical device companies without a physical presence in Brazil appoint a Brazilian Registration Holder (BRH) to legally register and sell their products in the Federative Republic of Brazil.
As an ANVISA-licensed BRH, GRP-Brazil ensures full regulatory compliance, facilitating product registration, certification, and market access in Brazil.
Our Services as Your Brazilian Registration Holder (BRH):
Pre-Market Services:
- Regulatory Strategy & Compliance with ANVISA requirements
- BGMP Certification (Brazilian Good Manufacturing Practices) for Class III & IV devices
- Technical File Preparation & Submission (Cadastro & Registro)
- Certification Support, including:
- INMETRO certification for regulated products
- ANATEL certification for telecom-related medical devices
- Liaison & Communication with ANVISA, including:
- Assistance with ANVISA inspections
- Organizing & supporting ANVISA consultation meetings
Post-Market Services:
- Adverse Effect Reporting & Vigilance Compliance
- BGMP maintenance
- INMETRO maintenance
- Recall & Incident Report Assistance
- Importation Process Support
- Distributor Management & Oversight
- License Renewal & Regulatory Maintenance
Pharmaceuticals
Brazil’s Regulatory Authority:
Global Regulatory Partners, Inc. (GRP), provides end-to-end regulatory affairs services that allow our clients register their drug, biologic or generic products in different countries at record time. Our regulatory services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, products’ registration and products’ life cycle management.
Through our local office in Brazil GRP can act as your local authorized agent in Brazil and our regulatory team can support your company throughout the whole products’ lifecycle, ensuring compliance with local regulations and providing vital scientific and strategic advice from products’ development till commercialization.
Pharmaceuticals in Brazil are governed by ANVISA, the Agência Nacional de Vigilância Sanitária, under the Brazilian Ministry of Health. ANVISA is an autonomous arm of the government and is responsible for the protection of the public’s health.
GRP Group has local offices in Brazil and is licensed by ANVISA to act as your authorized local representative. GRP Group can act as your local agent in Brazil for pharmaceuticals and biologics, ensuring compliance with ANVISA regulations.
Brazilian Registration Holder (BRH) Requirements
The Brazilian Health Regulatory Agency (ANVISA) mandates that any foreign medical device, pharmaceutical, or biologics company without a physical location in Brazil must appoint a Brazilian Registration Holder (BRH). The BRH acts as a liaison between your company and ANVISA and is responsible for pharmaceutical and medical device registration in Brazil.
GRP Services as Brazilian Registration Holder (BRH)
Pre-Market Services:
Product Licensing / Local Representation
Regulatory Intelligence
Regulatory Strategy
Organize and support ANVISA consultation meetings.
BGMP (Brazilian Good Manufacturing Practice) certification
Product Registration
Post-Market Services:
Control & maintain your registrations and BGMP certification.
Post-market surveillance maintenance.
Adverse Effect Reporting.
Recall or incident report assistance.
Importation Support.
Distribution.
Product License Renewal.
Cosmetics
Global Regulatory Partners Inc., affiliate in Brazil (GRP-Brazil) is authorized by Anvisa and can help your company find the right regulatory pathway for your cosmetics in Brazil. GRP’s team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics and can help you register your Cosmetic product in Brazil and find the appropriate local distributor for your product.
In Brazil, Cosmetics are regulated by the Brazilian Health Regulatory Agency (Anvisa) under Resolution RDC 752/2022 related to personal hygiene products, cosmetics and fragrances market authorization in Brazil. Foreign manufacturers that want to import cosmetics products into Brazil need to assign an Authorized Local Agent who will handle their products’ registration in the country.
GRP Group has local offices in Brazil and is licensed by ANVISA to act as your authorized local representative. GRP Inc. can act as your local agent in Brazil for your cosmetic and personal care products, ensuring compliance under Resolution RDC 7/2015, as amended by Resolution RDC 237/2018.
GRP Brazil Cosmetic Services:
Authorized Local Agent
Regulatory Intelligence
Regulatory Strategy
Regulatory Affairs
Product Registration
Cosmetic Packaging and Labeling Review
Product Classification & Formulation Review
GRP Product Review and Registration Services:
Analysis of the list of cosmetic and PCP ingredients
Review of product formulation and labeling
Overall product compliance review to meet ANVISA and MERCOSUR resolutions
Food Supplements
Global Regulatory Partners, Inc. (GRP), has a team of experts in Brazil who can help Nutraceutical and food supplements companies in Brazil during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers and are within the daily dose limits allowed by local regulations. The team also reviews and validate the content of the products labeling and packaging and makes sure that nutrient content claims and health claims made by the manufacturer are validated and supported by scientific data before any products’ commercialization.
Local Representation & Regulatory Affairs
Formula Review & Compliance
- Analyze product formulation against Brazilian standards.
- Verify ingredient acceptability and any restrictions.
- Ensure compliance with ANVISA’s food, cosmetic, or pharmaceutical regulations
Label Compliance Review
- Ensure compliance with Brazilian regulatory requirements.
- Verify accuracy of product information, ingredient listings, and usage instructions.
- Confirm labeling aligns with ANVISA (Agência Nacional de Vigilância Sanitária) guidelines.
Product Registration
- Prepare and submit necessary documentation for registration.
- Coordinate with regulatory authorities for approval.
- Ensure product is authorized before entering the market.
Brazilian Registration Holder (BRH) Responsibilities
- GRP holds the proper licenses to act as your representative in Brazil.
- Liaise with regulatory authorities (ANVISA, MAPA, etc.).
- Ensure ongoing compliance and post-market surveillance responsibilities.