Brazil’s ANVISA has issued new regulations defining registration requirements for medical devices and in vitro diagnostics that likely will require industry to revise technical documents by Oct. 26.
In RDC 40, ANVISA removed a list of Class 1 and 2 devices that still required the longer registro process. Most Class 1 and 2 devices went through the abbreviated cadastro process — now all will.
In RDC 36, Anvisa now has included Class 2 IVDs in the cadastro process. Class 1 IVDs already were under cadastro.
Also, IVD equipment, which in the past was under the general medical devices regulation, is now included in the IVD regulation.
IDDM asked Marcelo Antunes, regulatory affairs strategy consultant at SQR Consulting in São Paulo, to explain how the new regulations will affect industry.
IDDM: What kind of burden will this impose on industry?
Antunes: Industry will probably need to revise technical documents — for both IVDs and all other devices — because there are new requirements related to the technical dossier.
On the other hand, cadastro will be exempted from the five-year renewal (meaning that they won’t need to be renewed anymore — the maintenance of the cadastro will be tied to compliance to the requirements of Good Manufacturing Practice, applicable technical standards and specific regulations, when they exist).
Devices under registro still need a five-year renewal, but there’s a proposal to extend that to 10 years.
IDDM: Do you anticipate any challenges for devicemakers in coming months?
Antunes: There are new requirements — for example, a new, explicit requirement for human factors/usability — that will require some work on the part of manufacturers.
The revised requirements from the technical dossier are in line with International Medical Device Regulators Forum expectations. However some, such as human factors/usability will be “new” to Brazilian regulations.
IDDM: What do you see as the biggest impediment for manufacturers to remain in compliance as they prepare for the changes related to regulations?
Antunes: The technical requirements — for example, those for human factors and software, as well as revised ones for clinical information — will be problematic.
In the case of imported devices, a typical problem is that the original manufacturer does not want to share technical information with the Brazilian registration holder — now it must.
IDDM: What is the single most important piece of advice you can give industry as it prepares for the changes resulting from the regulations?
Antunes: ANVISA has been very clear in saying that, although they are lessening the regulatory burden (in the case of cadastro, they removed the renewal requirement, for example) it wants manufacturers and importers to have all of the technical documentation in place, and also have active process in place, including risk management and postmarket surveillance. In the case of devices with mandatory certification, the validity of the cadastro is now tied to the certificate.
In general, the regulations now are much more technical in nature, and manufacturers and importers have to plan carefully and implement a strategy to deal with these and other new and expected requirements.