top of page

How to Register a Medical Device in Latin America: A Comprehensive Guide


Latin America represents a promising market for medical devices, characterized by a diverse regulatory landscape. Entering these markets requires a thorough understanding of each country's specific regulatory requirements. In this blog, we share a summary guide to help you navigate the registration process for medical devices in key Latin American countries.

Brazil (ANVISA):

  • Regulatory Authority: The National Health Surveillance Agency (ANVISA) is responsible for medical device regulation.

  • Classification: Devices are classified into four classes (I to IV) based on risk.

  • Registration Process:

  1. Appoint a Brazilian Registration Holder (BRH): Foreign manufacturers must have a local representative in Brazil.

  2. Obtain Good Manufacturing Practice (GMP) certification: ANVISA's GMP requirements are aligned with ISO 13485, but an inspection of foreign manufacturing facilities is required.

  3. Submit Technical Documentation: This includes device labeling, instructions for use, and clinical evidence.

  4. Registration Approval: Once approved, the registration is valid for up to 10 years, depending on the device class.

Mexico (COFEPRIS):

  • Regulatory Authority: The Federal Commission for Protection against Health Risks (COFEPRIS).

  • Classification: Devices are categorized into I, II, and III classes, with Class I being the lowest risk.

  • Registration Process:

  1. Local Legal Representative: Non-resident companies need a Mexican legal representative.

  2. Compliance with Mexican Official Standards (NOMs): Certain devices must meet specific NOMs.

  3. Technical Documentation: Submission includes proof of ISO 13485 certification, risk analysis, and clinical data.

  4. Registration Approval: Registration is valid indefinitely, but modifications to the device require notification or re-registration.

Argentina (ANMAT):

  • Regulatory Authority: The National Administration of Drugs, Food and Medical Technology (ANMAT).

  • Classification: Devices are classified into four classes based on the level of risk.

  • Registration Process:

  1. Appoint a Local Representative: Foreign manufacturers need an Argentine Distributor.

  2. GMP Compliance: Similar to ISO 13485 standards, but local certification is required.

  3. Technical Documentation Submission: Includes detailed information about the manufacturing process, quality control measures, and clinical trials.

  4. Registration Approval: Validity varies from 5 to 10 years, depending on the device.

Colombia (INVIMA):

  • Regulatory Authority: The National Institute for Food and Drug Surveillance (INVIMA).

  • Classification: Medical devices are classified into I, IIa, IIb, and III categories.

  • Registration Process:

  1. Local Representative Required: Must have a legal representative in Colombia.

  2. Compliance Documentation: Submission of technical documents, including clinical studies and ISO 13485 certification.

  3. Quality System Requirements: Must comply with INVIMA’s quality system requirements.

  4. Registration Approval: Once approved, registration is valid for 10 years.

Chile (ISP):

  • Regulatory Authority: The Public Health Institute (ISP).

  • Classification: Devices are classified from low risk (Class I) to high risk (Class IV).

  • Registration Process:

  1. Local Representative: Foreign manufacturers must appoint a Chilean representative.

  2. Technical Documentation: Submit device specifications, clinical data, and a declaration of conformity.

  3. Quality Management System: While not mandatory, a QMS similar to ISO 13485 is recommended.

  4. Registration Approval: Device registration is valid for five years and is renewable.

Key Considerations Across Latin America:

  • Local Representation: A common requirement is having a local representative or distributor.

  • Quality Management System: ISO 13485 is widely recognized, but some countries require additional certifications or inspections.

  • Technical Documentation: Detailed documentation, including clinical data, is crucial for registration.

  • Renewal and Post-Market Surveillance: Regulatory authorities require periodic renewal of registrations and have specific requirements for post-market surveillance.


Entering the Latin American medical device market requires careful planning and an understanding of each country's regulatory framework. Companies should prepare for diverse regulatory processes, language barriers, and the need for local partners. Despite these challenges, Latin America offers significant opportunities for medical device manufacturers willing to navigate its complex regulatory landscape. Contact us today and learn how OneGlobal Trinity M Consulting can help you navigate through the complex regulatory landscape.


bottom of page