Considering expanding your medical device business to Southeast Asia or Brazil? Qualtech Consulting Corporation's recent webinar offered valuable insights to help you navigate the regulatory landscape in these dynamic markets.

Brazil's Booming Market Awaits

The webinar highlighted the immense potential of Brazil's medical device market, boasting a vast healthcare network and a significant gap filled by imports. With more than 7,000 hospitals and 20,000 diagnostic laboratories, nearly 80% of medical devices used in Brazilian hospitals rely on international suppliers. This presents a lucrative opportunity for foreign manufacturers seeking to expand their reach.

Experts from our partner Vera Rosas Group, one of the leading consultancy groups in Brazilian regulations, provided a roadmap to enter the market.

  • Understanding ANVISA: The Brazilian National Health Surveillance Agency (ANVISA), established in 1999, is responsible for regulating and approving a wide range of products that impact public health in Brazil. This includes food, cosmetics, medications, medical devices, and more.
    ANVISA has an electronic submission system for various regulatory processes.  They classify medical devices into four classes based on risk.  Lower-risk Class I and II devices require notification for approval, with a processing time of up to 30 days and validity that is undetermined. Higher-risk Class III and IV devices require registration for approval, with a longer processing time of 4-15 months but a validity of 10 years.

  • Leveraging International Recognition: Qualify for faster market entry by utilizing existing foreign approvals from recognized agencies like MDSAP and MRA partners.

ASEAN Updates: Staying Ahead of the Curve

The ASEAN portion of the webinar, led by Qualtech's Vice General Manager Irene Lu, also provided a comprehensive overview of current medical device regulations across key ASEAN countries (Indonesia, Singapore, Malaysia, Philippines, and Thailand).

To learn more about the updates discussed during the webinar, we welcome you to check out Qualtech’s regulatory updates section on our webpage.

Partner with Qualtech for Success

Qualtech Consulting Corporation is your one-stop shop for navigating the complexities of medical device regulations in Brazil and ASEAN. Our team of experts can guide you through the entire process, from initial market entry to ongoing compliance.

Ready to unlock your growth potential? Contact Qualtech Consulting Corporation today and take the first step towards success in these exciting markets!