Brazil’s Anvisa Announces New Medical Device Regulations
On September 18,2020 Brazil’s Anvisa published the RDC no. 423/2020 which deals with the extinction of the registration and migration of medical devices of risk class II to the notification regime.
Brazil’s Anvisa establishes New Standards on label warnings and formulas
Brazil’s Anvisa new standards require companies to warn about formula changes in products subject to health surveillance.
China’s NMPA Addresses Common Period Risk Evaluation Report (PRER) Issues
China’s NMPA updates and address some common issues faced by the Marketing Authorization Holders to submit PRER report.
Mexico’s COFEPRIS establishes new electronic Appointment System
From September,1st 2020 COFEPRIS establishes the request for appointments will be via the internet and face-to-face attention in the CIS for the entry of priority formalities.
Mexico’s COFEPRIS promotes the production of generic drugs with new operating rules
COFEPRIS establishes operating rules to promote the production of generic drugs in Mexico, by eliminating criteria that limited their production and their availability at more accessible prices for the population.
Face Mask Regulations by Australia’s TGA
Non-sterile face masks are regulated as medical devices under the Therapeutic Goods Act of 1989. Importation, distribution or exportation of any goods are required to be included in the ARTG (Australian Register of Therapeutic Goods).
Australia’s TGA regulations for cosmetics with sunscreens
In Australia, cosmetics that contain sunscreens (UV filters) are regulated by the Health Authority Therapeutic Goods Administration (TGA). The cosmetic can only be approved for market if it meets the legal definition of either ‘therapeutic’ or ‘cosmetic’.
FDA introduces Medical Device User Fee Amendments for Fiscal year 2021
Food and Drug Administration updates lists of Medical Device User Fees for Fiscal year 2021. and increases cost of certain MD submissions.
Brazil’s Health Authority requires Registration Holders to send daily information to ANVISA regarding drugs necessary in COVID-19 Pandemic
Companies that hold drug registrations must provide Anvisa daily information about the manufacture, import and distribution of anesthetics, sedatives, neuromuscular blockers and adjuvant agents, among other drugs used to maintain the lives of patients infected with the new coronavirus (Sars-CoV-2).
FDA fills in the details with guidance for Marketing Status Notification
In 2017, the Reauthorization Act (FDARA) made it mandatory for drug marketing holders to notify the FDA about the status of the NDA or ANDA product withdrawal. The FDA releases guidance on how to update the FDA appropriately.
Good Manufacturing Practices Certificate (CBPF) Renewal with Brazil’s Anvisa
Every Two years in Brazil, Manufactures must renew their GMP certificate known as CBPF, incorrect petition of this renewal will lead to rejection or return.
United Kingdom’s MHRA releases a list of exempted medical devices
United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) developed a list of medical devices which can be marketed without CE marking.