Asia-Pacific – COVID-19 outbreak triggers regulatory interventions in Asia-Pacific region

The alarming worldwide diffusion of COVID-19, also known as novel coronavirus, has inspired numerous governments to intervene to counter the spread of the disease. For their part, regulatory bodies that govern medical devices have taken steps to ease import restrictions and expedite registration processes for needed goods, seeking to ensure that regulations do not block the development or supply of devices that could save lives. What follows is a roundup of regulatory updates from the Asia-Pacific region pertaining to the outbreak.

Chinese regulatory bodies roll out numerous emergency regulatory changes

  • The National Medical Products Administration (NMPA) announced that they will ​expedite the registration of medical protective clothing devices that meet relevant standards from the EU, US, or Japan, as well as the Chinese standard GB 19082-2009 (Technical Requirements for Single-Use Protective Clothing for Medical Use), as a temporary emergency measure.
  • The Center for Medical Device Evaluation (CMDE) announced adjustments to their medical device application acceptance and consultation services, beginning on February 3. The CMDE encourages the use of their online eRPS system and will temporarily suspend on-site acceptance of applications and consultation services…