Brazilian medical device market regulator ANVISA recently discussed revisions to planned requirements for custom-made devices with Emergo by UL consultants prior to finalization and official publication of the new rules.

Subjects discussed in the meeting between ANVISA and Emergo by UL included evidence that Brazilian regulators are seeing a major increase in submissions for custom-made devices including 3D-printed medical products in recent years, prompting the need to define specific criteria for these devices including their importation and manufacturing.

Under ANVISA’s current system, custom- and patient-specific device applications must go through a specialized submission process for ANVISA review, with no specific Brazilian regulations to serve as reference in these cases. Thus, with a lot of back and forth between ANVISA, applicants and market sources without the support of regulatory guidelines, market access for custom-made devices can take a lot of time.

Formalizing Brazilian market access for custom-made devices

ANVISA’s proposed new regulatory system for custom-made devices distinguishes between three main types of such products:

• Custom-made devices: intended exclusively for use by particular individuals, and manufactured specifically according to an authorized healthcare professional. The professional is responsible for specific design features, even in cases where a project can be developed in collaboration with the device manufacturer.
  • Step One: Class III and IV custom-made devices must request BGMP quality system inspections; Class I and II devices do not have to submit such requests.
  • Step Two: Manufacturers of all classes of custom-made devices must submit Requests for Consent to manufacturer or import such a device per a manufacturing plan.
  • Step Three: Manufacturers of Class III and IV devices must submit Requests for Consent to notify ANVISA of the manufacturing or importing of each individual custom-made device they have produced. This requirement is not applicable to Class I and II device manufacturers.
• Adaptable medical devices: mass-produced devices that undergo adaption, adjustment, fitting or molding based on a manufacturer’s instructions at the point of care to address a patient’s particular anatomic and physiological characteristics before use.
  
  • Adaptable medical devices must undergo ANVISA registration.
• Patient-specific medical devices: devices made compatible to a patient’s anatomy via anatomical reference sizing techniques, or via anatomical features obtained from imaging examinations in batch productions able to be validated and reproduced.
  
  • Patient-specific devices will require registration with ANVISA under the new regulatory system for custom-made devices.

This new regulation will define specific criteria based on the device risk classification for the notification of custom-made manufacturing, importation and vigilance responsibilities, as well as detail a clearer Brazilian market pathway for patient-specific and adaptable medical devices.

Luiz Levy, Director of QA/RA at Emergo by UL in São Paulo who attended the meeting with ANVISA, observed, “ANVISA made many interesting updates after receiving comments from the market, and these updates should allow companies to properly document custom-made device manufacturing and importing requests.

“Additionally, ANVISA updated its regulation of devices classified as patient-specific, which as a consequence will certainly help devices with these features reach end-users and patients faster in Brazil.”

Learn more about Brazil’s medical device regulatory system at Emergo by UL:

• Brazil ANVISA medical device registration consulting
• Brazil ANVISA registration holder in-country representation
• Whitepaper: ANVISA medical device registration in Brazil