Brazil

View our Brazilian Market Access services

We work with clients to solve their biggest challenges in regulatory affairs, quality assurance, and device risk mitigation.

New Brazil INMETRO ordinance eases inspection and documentation requirements

ANVISA Medical Device and IVD Registration and Approval in Brazil

Emergo can assist you in gaining Brazil's ANVISA regulatory approval to sell medical devices on the Brazilian market.

US FDA rolls out notification requirements to protect medical device supply chains

Brazil ANVISA Medical Device Classification Consulting

Emergo by UL represents hundreds of medical device and IVD companies in Brazil. Our Brazil team specializes in medical device registration and can help you determine the proper ANVISA classification for your medical device.

Brazil ANVISA Registration Holder service for medical device companies

Brazil ANVISA Registration Holder Service for Medical Device and IVD Companies

ANSWERED ON THIS PAGE:

Are we required to appoint an in-country representation to sell in Brazil?
What should we consider when choosing a Brazil Registration Holder (BRH)?
What are the responsibilities of a Brazil Registration Holder?

Brazil GMP (B-GMP) Quality System Compliance

Learn about how Emergo by UL can help you comply with Brazilian GMP quality system regulations for medical device companies.

Brazil INMETRO Certification Consulting for Medical Devices

INMETRO Certification Consulting

Certificate of Free Sale (CFS) for Medical Device Exports

Emergo has obtained CFS documents for many clients seeking medical device registration in Asian, Middle Eastern, and Latin American markets, and can procure a CFS on your behalf for your medical device.

Customized Regulatory Pathway Reports for Smaller International Markets

In most major markets the path to medical device regulatory approval is well documented. The process may not be easy, but it is well understood. That’s not true in all countries, especially some countries in Latin America, Southeast Asia, Africa and the Mi

Business person sitting at a conference table with two medical professionals

Independent Regulatory Representation for Medical Device Companies

Emergo by UL offers qualified in-country representative and regulatory representation for over 500 medical device companies worldwide.

ISO 13485:2016 Consulting and Gap Analysis

ANSWERED ON THIS PAGE:

What are the deadlines for ISO 13485:2016 certification?
How should we approach the transition to ISO 13485:2016?
What are the biggest changes in ISO 13485:2016?

ISO 14971 Risk Management Consulting for Medical Device Companies

ANSWERED ON THIS PAGE:

What does ISO 14971 require?
How do I implement ISO 14971?
How do I apply the risk management system and concepts to my product?

Medical Device and IVD Registration and Approval in Thailand

Medical device and IVD registration with the Thai Food and Drug Administration (FDA). Get our local support for approval.

Medical Device Single Audit Program (MDSAP) Internal and Gap Audits

ANSWERED ON THIS PAGE:

What are the requirements for the Medical Device Single Audit Program (MDSAP)?
Which countries are participating in the MDSAP?
How can we achieve MDSAP certification?