Oct 13, 2020

Brazil’s National Health Surveillance Agency (ANVISA) has issued an up-to-date list of healthcare products exempt from regulation and a new cybersecurity guide for medical devices.

GGTPS publishes updated list of products exempt from regulation

The General Administration of Health Product Technology (GGTPS), an office of ANVISA, published an expanded list (link in Portuguese) of healthcare products that are not subject to its regulation. The update, which appeared in Technical Note No. 209/2020, added 33 product types to the previous list of exemptions.

A sample of some of the newly exempted product types follows:

  • Pliers and scissors for cutting nails
  • Wheelchair cushions, other than for ulcer prevention
  • Bibs for dental use
  • Surgical marking pens
  • Packaging for sterilizing medical products
  • Packaging for organ transportation and storage
  • Hospital clothes hampers and hamper bags
  • Toilet paper and paper towels
  • Eyeglass lens cleaners
  • Disposable hospital bedding
  • Hospital waste collection bags
  • Body bags
  • Orthopedic heels

ANVISA releases new medical device cybersecurity guide

ANVISA also published Guide No. 38/2020 (link in Portuguese), Principles and Practices of Cybersecurity in Medical Devices, which is based on the IMDRF/CYBER WG/N60 guidance issued by the International Medical Device Regulators Forum (IMDRF). The 45-page document includes a comprehensive treatment of general cybersecurity principles as well as guidance on documentation for regulatory submissions. Discussion of major points is divided into sections on pre- and post-market considerations.

Guide No. 38/2020 went into force upon publication in late September, and ANVISA is soliciting public comments on it until March 23, 2021.

Learn more about Brazilian medical device regulations at Emergo by UL:

Author

  • Timothy Herr

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