Newsletter
The Medical Device Management Act will come into effect on May 1, 2021
Currently, medical devices are regulated by the Pharmaceutical Affairs Act (the "PAA") alongside drugs. Nonetheless, given the materials, R&D process, risk, usage and sales model of medical devices varying from those of drugs, it is not ideal for the PAA to cover all aspects. In this respect, the Medical Device Management Act (the "MDMA") was passed by Taiwan's congress (i.e., the Legislative Yuan) on December 13, 2019, and promulgated by the President on January 15, 2020 with the intent to regulate medical devices by a specific law. However, since there are many regulatory details that need to be formed, Article 85 of the MDMA provides that the enforcement date thereof will be determined by the cabinet (i.e., the Executive Yuan) so that the competent authorities may have time to set the relevant regulations and the industry can have a grace period to adapt to the new law.
After the MDMA was promulgated by the President on January 15, 2020, the competent authority, the Ministry of Health and Welfare (the "MOHW") started to form the relevant regulatory details, including successively announcing 38 sets of regulations, such as the Enforcement Rules of MDMA, from March 2020 to collect public opinion, and it has reached a considerable degree of preparation work. Thus, the cabinet announced on February 17, 2021 that the MDMA will come into effect on May 1, 2021. Regarding the 38 sets of regulations mentioned above, as of April 6, 2021, eight of them have been officially promulgated and the competent authority will continue to promulgate the other regulations so that they can become effective with the MDMA on the same day. In addition, according to Article 83 of the MDMA, starting from May 5, 2021, the provisions of the PAA governing medical devices shall no longer be applicable.
Regarding the highlights of the MDMA, please refer to our introduction of February 2020 (https://www.leeandli.com/EN/Newsletters/6422.htm); Lee and Li has a Life Sciences Practice Group specializing in medical law. Should you have any further questions, please do not hesitate to contact us.