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…