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
||Simple surgical instruments, tongue depressor
||Digestive catheters, infusion pumps, andÂ powered wheelchairs
||Dialyzers, and orthopaedic implants
||Class I and II Devices do not expire. Class III and IV: Five years
||May be initiated as early as one year before device registration expires, and no later than six months.
||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.
||All documents must be translated into Portuguese.
||Class I and II Devices: 1-3 months.
Class III and IV devices: 3-4 years. This is due to the GMP certification