On 30.03.2020, the NMPA (National Medical Products Administration) released an overview of the latest regulatory standards in response to the coronavirus epidemic, guiding manufacturers, NMPA Legal Agents, and companies with the suitable pathway for the registration application of certain medical supplies in China.
1. Registration requirements for coronavirus reagent test kits
As of 30.03.2020, a total of 23 coronavirus test kits (15 nucleic acid reagent test kits and 8 antibody test kits) had been registered with NMPA emergency approvals. Coronavirus reagent test kits are classified as Class III medical devices, and are required to submit the following materials for the application of NMPA registration:
– Application form
– Proof of qualifications
– General information
– Research information on the major raw materials used
– Research information of the manufacturing techniques and reaction systems
– Performance analysis
– Information to determine positive value or relevant references
– Research information on the stability performance
– Records of production and self-testing
– Clinical evaluation information
– Risk analysis
– Technical requirements
– Testing reports for product registration
– Instructions for use
– Samples of labelling
– Declaration of conformity
2. Regulatory requirements for medical protective equipment
– NMPA guideline for technical review of medical face masks
– NMPA guideline for technical review of single-use surgical gowns
– NMPA guideline for technical review of single-use surgical packs
3. Product standards for medical protective equipment
– GB19082-2009 Technical Requirements for Single-use Protective Clothing for Medical Use
– GB19083-2010 Technical Requirements for Protective Face Masks for Medical Use
– YY/T0969-2013 Single-use Medical Face Mask
– YY0469-2011 Surgical Masks
4. Enhanced market surveillance of medical protective equipment
Medical masks and protective clothing
– China regulatory standards for Class II medical devices
– Manufacturers must obtain the appropriate licenses issued by the provincial MPA before production
Goggles and face shields
– China regulatory standards for Class I medical devices
– Manufacturers must file the records with the municipal MPA before production
QMS / GMP
– Manufacturers must establish a QMS (Quality Management System) for operation procedures to ensure the medical device products manufactured meet technical requirements
– Manufacturers must meet the requirements of GMP (Good Manufacturing Practice)
– Manufacturers must meet the requirements of GMP for sterile medical devices, if applicable
– Manufacturers are responsible to conduct self-inspections regularly and submit report results to the provincial MPA
5. Strengthen post-market surveillance of coronavirus reagent test kits registered with emergency approval
– Provincial MPAs are required to strengthen their post-market supervision on manufacturers
– NMPA Legal Agents must fulfil the responsibility to monitor and report any adverse incidents in a timely manner
On 09.04.2020, the Standardization Administration of the SAMR (State Administration for Market Regulation) announced plans to release 13 foreign language versions of national standards to address the technical requirements of protective face masks, giving support to more than 30 coronavirus affected countries such as Bangladesh, Serbia, Italy, Iran, etc.
By Jacky Li. Contact Cisema to learn more.
