In early March, we reported on emergency measures being employed in various Asia-Pacific countries, including China, to combat the COVID-19 pandemic. Since that time, some noteworthy new developments have occurred as part of China’s regulatory response.
Detailed requirements for IVD test kits and PPE
On March 30 the National Medical Products Administration (NMPA) summarized the regulatory requirements and standards for COVID-19 IVD detection reagents and personal protective equipment (PPE), as follows:
- The NMPA classifies COVID-19 detection reagents as Class III IVDs. Therefore, companies must apply for registration and submit the required documents, which are listed in the announcement.
- Medical masks and protective clothing are regulated as Class II medical devices, while goggles and face shields are regulated as Class I medical devices. Three mandatory Chinese standards and one voluntary standard are applicable to these devices, as follows: (1) GB 19082-2009 (Technical Requirements for Single-Use Protective Clothing for Medical Use), (2) GB 19083-2010 (Technical Requirements for Protective Face Mask for Medical Use), (3) YY 0469-2011 (Surgical mask), and (4) YY/T 0969-2013 (Single-Use Medical Face Mask). The announcement also summarizes production licensing and Quality Management System requirements for these devices.
- The NMPA has also launched a page titled « Medical Device Registration Information in China » to help the public determine whether a domestic device or IVD pertaining to COVID-19 is registered…