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2020 MDSAP Forum
From December 2nd to 4th, 2020, NCC participated in the 2020 MDSAP (Medical Device Single Audit Program) Forum, which took place virtually, with the presentation of the RAs (Regulatory Authorities) of each member country (Australia, Brazil, Canada, Japan, and USA). Also, on occasion, the AOs (Auditing Organizations) discussed essential topics on the approach to audits. […]
Brazilian Health Products Market x MDSAP
Many medical device companies see the Brazilian market as a market full of possibilities, but it can cause astonishment due to the peculiarities and bureaucracies that companies often find. Considering that ANVISA is a very well-structured agency, but relatively new compared to the FDA, for example, the dynamics and speed with which new regulations and […]
Black Friday: Cell Phones Homologation.
When a product is submitted to Anatel for assessment, it undergoes several tests. With cell phones, it is no different. Leonardo Tozzi Pinheiro, CEO of NCC and vice president of the Brazilian Association for Conformity Assessment (ABRAC), spoke about this and other homologation processes in an interview with the Brazilian Association for Conformity Assessment. Read […]
Is your fan safe?
In 2011, the IDEC (Brazilian Institute for Consumer Protection) presented a study on safety, seeing that this cheaper way of cooling off is a consumer good widely used worldwide. The most significant risks pointed out are the contact with the propellers and the oscillation mechanism (which allows the device to move), which is permitted by […]
Worldwide Regulatory Convergence for Medical Devices – ANVISA as an active regulatory authority towards this goal
Worldwide Regulatory Convergence for Medical Devices – ANVISA as an active regulatory authority towards this goal In recent years, ANVISA’s medical devices department has been working with guidelines based on global regulatory convergence and product risk. On the 2020-2023 Strategic Plan, ANVISA (Brazilian National Health Surveillance Agency) expressed interest in adopting regulatory strategies for simplification, […]
MDSAP
Another achievement for NCC MDSAP medical Device Single Audit Program We are now part of the MDSAP, Health Product Single Audit Program. ANVISA recognized NCC as the organization able to offer this service, which proves our experience in complying with complex and demanding regulations regarding quality, performance, and end-user safety. Contact our commercial team to […]
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