Significant ANVISA Changes to Impact Class I, II Medical Devices and IVDs in Brazil

New regulations published by Brazilian medical device market regulators will simplify some aspects of Class I and II device as well as IVD registrations, but also introduce some new requirements for these market applicants.

Update August 27 2015: ANVISA has now published the regulations mentioned below, which means these new rules will go into effect in 60 days. Over the long term, the new regulations will enable ANVISA to more efficiently manage device registrations since cadastro-registered devices will no longer need to be renewed. Over the near term, manufacturers affected by these changes should prepare to make any necessary changes to their documentation.

The new and updated regulations published by ANVISA include:

• RDC 36/2015 for cadastro and registro registration, labeling and IFU requirements
• RDC 37/2015 covering labeling information for devices with natural rubber latex components
• RDC 40/2015 on cadastro registrations
• IN 03/2015 covering IVD families

(All links in Portuguese)

Emergo consultants attended a meeting of regulatory agency ANVISA’s board of directors held August 20 2015 in Brasilia, where the effects of proposed new regulations on lower-risk device and IVD registrations were discussed.

Once the new regulations are published, ANVISA will begin a 60-day transition period for all affected registrants.

Simplified registration routes

Emergo learned that new ANVISA regulations will include the following streamlined requirements for Class I and II devices:

• Registration expiration dates, currently five years, will be removed for Class I and II devices as well as for IVDs; this allowance would apply to both currently approved devices and future registrations
• All Class I and II devices would go through the simplified cadastro registration route; Normative Instruction 2/2011, which specifies Class I and II devices that currently require more complex registro registration, will be revoked
• Companies with registro applications for Class I or II devices currently under ANVISA review will be required to update their applications with cadastro forms within the 60-day transition period following publication of the new regulations
• Regulations pertaining to IVDs—RDC 206/2006 and RDC 61/2011—will be replaced by a new regulation

New technical dossier requirements

On the other hand, ANVISA plans to require manufacturers and/or Brazil Registration Holders to compile and maintain technical dossiers on all Class I and II devices already approved by the regulator. This requirement will particularly impact devices with cadastro registrations, as these devices have not previously had to maintain such levels of documentation.

This would, in effect, constitute a new ANVISA requirement for affected companies, but they would have 360 days to comply following publication of the new regulation.

Any changes for Class III and IV devices?

No proposals to change registration requirements for Class III and IV medical devices or IVDs were discussed or considered at the ANVISA meeting. For now, these products remain subject to registro registration requirements and Brazil Good Manufacturing Practice (BGMP) compliance.