Brazil Anvisa regulation medical software samd
Brazil Medical Device Regulations

Agency
All medical devices are regulated by the The Brazilian National Health Surveillance Agency (ANVISA)
Medical Device Definition
A medical device is a healthcare product, such as equipment, devices, materials, articles, or systems for medical, odontological, or laboratory use or application, intended for prevention, diagnosis, treatment, rehabilitation, or anti-conception and that does not use pharmacological, immunological, or metabolic means to fulfil its main function in human beings, but have its functions assisted by such means. RDC 185/2001, Annex I.
Classification of Medical Device
Classification Examples Risk Level
Class I Simple surgical instruments, tongue depressor Low
Class II Digestive catheters, infusion pumps, and powered wheelchairs Low-Moderate
Class III Dialyzers, and orthopaedic implants High-Moderate
Class IV Coronary stents High
Premarket Approval Process
Class I Class II Class III Class IV
Only companies based in Brazil may apply for ANVISA registration. Therefore, a distributor or third-party company must be appointed to obtain registration. GMP is not easily transferable. If company selects distributor as registration holder, it is extremely difficult to switch distributors without full cooperation from original distributor. It is therefore recommended that companies choose a representative that is not involved in device sale.
All medical devices are required to comply with Brazil's Good Manufacturing Practices (GMP), which is similar to ISO 13485 and QSR. Most devices that comply with these will comply with GMP.
ANVISA will not conduct an audit of GMP compliance These devices will be audited for compliance and will need to submit a GMP certificate with their registration.
Abbreviated registration (cadastro): prepare technical dossier including legal documents and labeling information. Ordinary registration (registro): Prepare application documents including: general device information, certificate of free sale, GMP, instruction manual, labeling, clinical data, clinical studies (if applicable).
Representative submits application to ANVISA who will review it. If approved, device registration will be published in Diário Oficial da União (DOU).
Additional Information
Validity Class I and II Devices do not expire. Class III and IV: Five years
Renewal Application May be initiated as early as one year before device registration expires, and no later than six months.
Postmarket Surveillance One professional within the company is required to be responsible for post-market surveillance. Must notify the National System of Health Surveillance (SNVS) of any adverse events.
Language All documents must be translated into Portuguese.
Expected Time Class I and II Devices: 1-3 months. Class III and IV devices: 3-4 years. This is due to the GMP certification
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