Class I medical device registration with ANVISA (Brazilian Health Regulatory Agency) refers to the formal process through which a medical device is approved for sale and distribution in Brazil. Class I devices are considered to be of low risk, and as such, they are subject to simpler and less stringent regulatory requirements compared to higher-risk devices (Class II and III). This process ensures that the device meets safety, efficacy, and regulatory standards set by ANVISA, allowing it to be legally marketed and used in Brazil.

What Does Class I Medical Device Registration Mean?

1. Regulatory Approval:

   • Registering a Class I device with ANVISA means obtaining official authorization to sell and distribute that device in Brazil. The device is assessed to ensure it complies with Brazilian medical device regulations, such as those outlined in RDC 16/2013 (regulation for medical device registration) and other applicable regulations.

2. Compliance with Brazilian Standards:

   • The registration process ensures that the device adheres to specific standards, such as Good Manufacturing Practices (GMP), and may also require certification of compliance with an internationally recognized quality management system like ISO 13485.

3. Market Access:

   • Registration with ANVISA provides market access for the device within Brazil. Once approved, the device can be legally sold, distributed, and used by healthcare professionals and patients across the country.

4. Labeling and Packaging:

   • As part of the registration, the device's labeling must comply with ANVISA's requirements. This includes product information in Portuguese, including indications for use, warnings, and instructions, as well as proper packaging and traceability (e.g., batch numbers, expiry dates if applicable).

5. Low-Risk Category:

   • Class I devices are generally low-risk products that do not involve invasive procedures or high patient exposure. Examples include:
     • Basic medical instruments (e.g., bandages, surgical gloves).
     • Simple diagnostic tools (e.g., thermometers, stethoscopes).
     • Some dental instruments.

Key Aspects of Class I Registration with ANVISA:

1. Simpler Process:

   • Compared to higher-risk devices, the registration process for Class I devices is more straightforward and quicker. It generally involves a documentary review of the device’s technical documentation, labeling, and manufacturing practices.

2. Post-Market Surveillance:

   • After registration, the device must adhere to post-market surveillance regulations, ensuring that it remains safe and effective once in the market. Manufacturers and distributors must report any adverse events or issues with the device to ANVISA.

3. Local Representation:

   • If the device is manufactured outside of Brazil, the manufacturer must appoint a local representative or importer to act on their behalf in Brazil for registration, importation, and distribution purposes.

In Summary:

Class I medical device registration with ANVISA ensures that low-risk medical devices meet Brazilian safety, performance, and regulatory standards. It grants the manufacturer legal authorization to sell and distribute the device in Brazil. The process is typically quicker and less complex than for higher-risk devices, but it still requires compliance with ANVISA's requirements, including proper documentation, labeling, and post-market surveillance.

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