Anvisa publishes four new major resolutions on june 25, 2018. The board of the national health surveillance agency, using the powers that are conferred on it in sections iii and iv of art. The collegiate board of directors of the brazilian national health surveillance agency anvisa, in the. Defines all medical product cadastro registration requirements.
The joint board of directors of the brazilian health surveillance agency anvisa, in exercise of the powers conferred by items iii and iv of art. The rdc 362015 implements several new features, such as the examples below, but you need a detailed reading on the. We also can help you register your medical devices with anvisa. Brazilian health surveillance agency anvisa technical note. With the establishment of this resolution, the company applying for registration or registration of health products, must have extensive knowledge of technological content, use and application of its products for. Brazil medical device regulations anvisa guidelines. The work also analyses the strategies employed by the anvisa for inspection and monitoring of sector, as well as the transparency in the construction of the rdc 96 2008. The rdc also improved companies reported concerns about timing of filling the requests of i updating of data. The collegiate board of directors of the brazilian health surveillance agency, in the use of the attributions vested in it under article 15. Brazilian health surveillance agency anvisa guidance on. Forced degradation studies fds are essential in the development of stability indicating methods to gain understanding of the intrinsic stability characteristics of a drug substance ds. Anvisa published today, 27 august 2015, the drc 362015 resolution repealing the rdc 20606 and rdc 6111 resolutions, establishing in this way, new rules for risk rating, registration, registration, labelling and instructions for use products for in vitro diagnostic ivd. Procedures and requirements the technical requirements are regulated for the regularization of toiletries, cosmetics and perfumes and provides other provisions. Anvisa, in exercise of the attributions vested under section 4 in article 11 of the anvisa statue approved by decree no.
Makes provisions on the requirements related to the proof of compliance with good manufacturing practices for registration of healthcare registro products and makes other provisions. Impact from the recent issuance of anvisa resolution rdc. Comprehensive list of medical device regulations for medical devices sold in brazil. The united nations has reaffirmed its support for the transition process and ssr by means of several security council resolutions, and is conducting the united nations mission in the democratic republic of the congo monuc, which is contributing to the security and stability of the country. During the four years of discussion on the regulation of drug advertising in the country, the new anvisas resolution 96 2008, as well as other actions anvisa failed to. New brazils anvisa rules expand facilities for investors. Hence, the deadline for providing such requests was set on a case by case basis by rdc no. Viewing 1 post of 1 total author posts february 21, 2019 at 9. The collegiate board of director of the brazilian national health surveillance agency anvisa. Home forums hoopdirt forum rdc no 185 01 anvisa guidelines tagged. On june 25, 2018, the brazilian health regulatory agency anvisa published a new resolution rdc anvisa no.
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