Notícias
REGULATORY CONVERGENCE
The World Health Organization publishes list containing regulatory authorities for medical devices
The World Health Organization (WHO) has published the list of WHO Listed Authorities for Medical Devices (WLAs-MD). The Brazilian Health Regulatory Agency (Anvisa) is one of the 12 national regulatory authorities and regional regulatory systems recognized for their capacity to supervise the medical device field, which includes in vitro diagnostic products.
The list will support and facilitate the adoption of regulatory reliance among countries during the transition from the concept of Stringent Regulatory Authorities (SRAs) to the WHO Listed Authorities (WLAs) model. According to the organization, this initiative aims to strengthen international cooperation and to promote greater efficiency in regulatory processes related to medical products.
Besides Anvisa, the list includes the following agencies/authorities: Therapeutic Goods Administration (TGA) of Australia; the National Medical Products Administration (NMPA) of China; Health Canada; the European Medical Devices Regulatory Network; the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea; the Ministry of Health, Labor and Welfare (MHLW) of Japan; the Ministry of Health (MoH) of Russia; the Swiss Agency for Therapeutic Products (Swissmedic) of Switzerland; the Health Sciences Authority (HSA) of Singapore; the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom; and the Food and Drug Administration (FDA) of the United States.
According to the World Health Organization, the transitional list, published on July 1, is valid for five years and will serve as a preparatory step for the future formal designation of Listed Authorities in the field of medical devices. During this period, the scope of recognition for each regulatory authority will be detailed in conjunction with the WHO itself, as part of the performance assessment process required to achieve the definitive designation of "WHO Listed Authority" (WLA).
The way the list is used is the responsibility of each regulatory authority, agency, and any other users, who must consider the specific context of its application when adopting regulatory reliance mechanisms.