Regulatory Requirements and Standards for Coronavirus Reagent Test Kits and Protective Equipment in China
I. Requirements for registration of coronavirus reagent test kits
China classifies medical devices including in vitro diagnostic reagents into three categories according to risk levels. Class I has the lowest level of risk and Class III has the highest. Coronavirus reagent test kits are classified as Class III medical devices.
Enterprises applying for registration of coronavirus reagent test kits must submit the following materials:
1. Application forms;
2. Qualification documents;
3. General materials;
4. Research materials for major raw materials;
5. Research materials for major production techniques and reaction systems;
6. Evaluation materials of performance analysis;
7. Materials for determination of positive value or reference range determination;
8. Stability research materials;
9. Production and self-testing records;
10. Clinical evaluation materials;
11. Materials on analysis of product risks;
12. Technical requirements of products;
13. Product registration and testing reports;
14. Product instructions;
15. Labeling samples;
16. Declaration of conformity.
In response to the coronavirus epidemic, the Center for Medical Device Evaluation of the National Medical Products Administration (NMPA) has formulated the Technical Key Points for Coronavirus (COVID-19) Nucleic Acid Reagent Test Kit Registration Review and the Technical Key Points for Coronavirus (COVID-19) Antigen-antibody Detection Reagent Registration Review (Trial). The documents were prepared to guide enterprises in registration application.
As of March 30, 2020, the NMPA had approved 23 coronavirus test kits in response to the emergency, including 15 nucleic acid reagent test kits and 8 antibody test kits.
II. Regulatory requirements for protective equipment
The NMPA has issued guidelines for technical review of products related to epidemic prevention and control including medical face masks, single-use surgical gowns and single-use surgical packs.
III. Standards for protective equipment
China has formulated and issued the following standards for medical protective clothing and medical face masks: 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 and YY0469-2011 Surgical Masks.
IV. Enhance regulation of medical protective equipment (masks, protective clothing, goggles and face shields)
Medical masks and protective clothing are regulated according to the standards for Class II medical devices in China. According to relevant sections of China's Regulations for the Supervision and Administration of Medical Devices and the Provisions for the Supervision and Administration of Medical Device Manufacturing, a manufacturing enterprise must obtain production licenses issued by a provincial drug regulatory department before production.
Goggles and face shields are regulated according to the standards for Class I medical devices in China. A manufacturing enterprise must file the records with a drug regulatory department at districted city level before production.
Manufacturing enterprises must establish a quality management system for medical products and ensure its effective operation in accordance with the requirements of regulations on medical device manufacturing regulations in China. They must operate in strict accordance with the product technical requirements for products registered or filed for record and ensure that the medical devices manufactured meet the mandatory standards and product technical requirements for products registered or filed for record.
The quality system of aseptic medical device products shall not only meet the requirements of the Good Manufacturing Practice (GMP) for Medical Devices, but also the relevant requirements of China's Appendix for Aseptic Medical Device of Good Manufacturing Practice (GMP) for Medical Devices in China. Manufacturing enterprises shall regularly carry out self-inspection of the operation of their quality management systems, and submit self-inspection reports to the local drug regulatory departments.
V. Strengthen post-market surveillance of coronavirus reagent test kits that received emergency approval
The relevant provincial drug regulatory departments are required to strengthen supervision and inspection of the manufacturers of coronavirus reagent test kits based on the progress of registration review and approval. Manufacturing enterprises shall be urged to undertake the primary responsibilities by conscientiously fulfilling relevant requirements, carrying out production in strict accordance with the product technical requirements for products, and ensuring the effective operation of the quality management system. Manufacturers should also monitor any adverse events, track the use of the products, and ensure product quality and safety.
Related Documents (in Chinese):
1. Technical Key Points for Coronavirus (COVID-19) Nucleic Acid Reagent Test Kit for Registration Review
2. Technical Key Points for Coronavirus (COVID-19) Antigen-antibody Detection Reagent for Registration Review (Trial)
3. List of Approved Coronavirus Nucleic Acid Reagent Test Kits
4. Technical Guidelines for Medical Face Mask Product Registration Review
5. Technical Guidelines for Single-use Surgical Gown Review
6. Technical Guidelines for Single-use Surgical Pack Registration Review
7. GB19082-2009 Technical Requirements for Single-use Protective Clothing for Medical Use
8. GB19083-2010 Technical Requirements for Protective Face Masks for Medical Use
9. YY/T0969-2013 Single-use Medical Face Mask
10. YY0469-2011 Surgical Mask
The English version is for reference only. In case of any discrepancy or ambiguity of meaning between this English translation and the Chinese version, the latter shall prevail.