Medical device market - Brazil

Medical Device Registration in Brazil

Medical Device Market in Brazil is expected to reach around $8bn USD in 2023, and maintain an annual growing rate of at least 7% until 2027. However, processes to gain access to the National market are challenging due to the high level of regulation established for these products.

Registration at ANVISA (Brazilian National Health Agency) requires counting with a local representative, QMS and BGMP audits, as well as INMETRO certification (Safety certification, usually required for electro-medical devices subject to IEC 60601, as well as some other medical devices.)

Medical device market - Mexico

Mexico represents the second medical device market for the Latin America (LATAM) region. The authority responsible for the Medical Device registration and surveillance is COFEPRIS.  

Determining the device classification is a crucial step for the registration process, however, national regulations are ambiguous and challenges pertaining to language translations are also prevalent. Good news is clinical and performance studies are not always required to be performed locally.

Medical device market - Peru

The regulatory body for Medical Devices is the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) under the Ministry of Health (MINSA).

Key Legislation includes:

Law No. 29459: Law of Pharmaceuticals, Medical Devices, and Health Products.

Supreme Decree Nº 016-2013-SA: Regulation for Registration, Control, and Health Surveillance of Pharmaceutical Products, Medical Devices, and Health Products.

Classification of devices is based on risk factors, contact duration, invasiveness, and effects, aligned with IMDRF guidelines.

Manufacturers need to provide the following registration documentation:

• Application

• Free Sales Certificate (or equivalent)

• Good Manufacturing Practice certificate (or equivalent)

• Technical Report

• Technical and Analytical Studies

• Disposal methods (if applicable)

• Draft package labeling

• Fee

• Additional documents based on device class

Timelines and Costs

Class I: 60 days, ~462 USD

Class II: 90 days, ~524 USD

Classes III and IV: 120 days, ~611 USD and ~685 USD respectively

DIGEMID's VUCE (Single Window of Foreign Trade) system facilitates electronic submission and communication, streamlining the regulatory process.

Understanding Peru's medical device regulations and utilizing tools like the VUCE system can help foreign manufacturers efficiently navigate the market and achieve compliance.

Medical device market - Argentina

In Argentina, medical devices are regulated by the National Administration of Drugs, Foods, and Medical Devices (ANMAT). The regulatory framework adheres to the Global Harmonization Task Force (GHTF) guidelines, which are similar to the European Union classification system. Devices are categorized into four classes based on risk: Class I (low risk), Class II (medium risk), Class III (high risk), and Class IV (highest risk).

In vitro diagnostic (IVD) devices are classified separately: Class A represents low risk (e.g., clinical chemistry analyzers), Class B moderate risk (e.g., pregnancy tests), Class C high individual risk (e.g., PSA screening), and Class D high public health risk (e.g., HIV screening).

Labeling for medical devices must include device identification, intended use, instructions for use, contraindications, and warnings, all in Spanish. Higher-class devices also need to provide technical specifications, recognized symbols, sterilization information, and clinical data.

Registrations are valid for five years, with revalidation required 30 days before expiration. Required documentation includes registration forms, a GMP certificate, a CFS, and technical reports, varying by device class.  ANMAT requires Certificates of Free Sale (CFS) from recognized countries such as the USA and the EU. Class III and IV devices may require risk analysis, clinical trial results, and other extensive documentation.

The processing time for Class I and II devices is 15 business days, while Class III and IV devices take 110 days. 

Fees:

Medical Devices

Class I - ~246 USD

Class II - ~316 USD

Class III - ~420 USD

Class IV - ~586 USD

IVD

Class A & B - ~223 USD

Class C & D - ~276 USD

ANMAT’s regulations ensure that medical devices in Argentina meet international safety and effectiveness standards, facilitating global market access for manufacturers.

Therefore, there is no need to worry, at OSMUNDA, we can support you with every step in the process to successfully place your device in to the Brazilian and Mexican Market. 

Interested in Americas markets? Contact us！