Expanding into LATAM for medical device manufacturers
This is the third short article in a 3-part series written by IMed’s own Daniel English. Following on from with part 2 with part 3 in this global expansion review we look in the Latin America region.
This short article will provide an overview of those classification systems, requirements and regulatory pathways for Brazil, which often have commonality with other countries within the same region.
The Brazilian medical device market is in fact the largest in the LATAM region and according to Market Research Future, Brazil’s medical devices market is expected to reach a value of US$1.8 billion by 2023.
Leverage MDSAP to enter the Brazilian market
Medical Devices in Brazil are regulated by the Brazilian Health Surveillance Agency (ANVISA) and all devices must complete a device registration process. Foreign manufacturers will require a local Brazilian Registration Holder (BRH) to submit technical documentation to ANVISA.
All manufacturing locations must also comply with Brazilian GMP requirements and regulations which are similar to the ISO 13485 standard. Brazil recognises the Medical Device Single Audit Programme (MDSAP), allowing manufacturers to undergo a single audit of their Quality Management System to satisfy the requirements of Australia, Brazil, Canada, Japan and the United States.
Brazilian classification for medical devices
Brazilian classification for medical devices ranges from Class I (low risk) to Class IV (high risk) and the registration requirements will depend on the classification. Class I and II devices have a simplified shorter registration pathway, while products considered high-risk classes (III and IV) are subject full registration process called (Registro). Both pathways will require a technical documentation dossier for your device with an increased requirement for clinical data, studies and more detailed device information for Higher class device submissions.
Manufacturer of Class I and II devices can submit via the Notification system which simplifies and speeds up market access for low-risk devices into a notification style process which does not require lower class devices to undergo full Cadastro approval or technical review. Manufacturers submitting Class I and II devices under this notification system need only to ensure technical documentation is robust, up to date and that the devices classified accurately. Please note that ANVISA can cancel lower class notification submissions for lack of proper documentation, incorrect classification, or complaints and the notification pathway does not change the required Cadastro documentation requirement.
Things to consider for medical device manufacturers expanding into Brazil
- There are three ways for the legal establishment of a company in Latin America (Distributor, Regulatory Agency or Legal establishment)
- Brazilian Registration Holder (BRH) controls your registrations and your GMP certification so choose carefully because a dedicated regulatory agency in market is a way to avoid conflicts of interest.
- IFUs, labels and ANVISA forms must be submitted in Portuguese; other documents may be provided in English
- Brazil has recently further aligned with the classification rules of the European Union’s Medical Devices Regulation (MDR)
Contact IMed Consultancy if you would like more information on the potential for your product in Singapore, Saudi Arabia or Brazil as well as the whole of APAC, MENA and LATAM.
Regulatory Affairs Consultant