Since the Coronavirus outbreak, the prevention and control work were deployed as the top priority of the China government at all levels. Due to the urgent demand of overseas medical products, the registration process was expedited to follow the Emergency Examine and Approval Procedure for Medical Device (No.565-2009) that was officially released in August 2009 by the State Food and Drug Administration (former NMPA).
According to the Procedure, the registration approval can be received as soon as five days and the registration tests will be carried out within 24 hours after receiving the samples. Once the registration application is accepted, the technical review and the administrative approval will be completed by the food and drug administrative departments within a time period subjected to the classification of the medical devices as listed in the table below:
The number of institutions are listed with the respective testing capability in the table below:
Medical Device | Technical Review | Administrative Approval |
Class I | 5 Days | |
Class II | 5 Days | 3 Days |
Class III | 10 Days | 3 Days |
During the past two months, medical products were urgently approved through the expedited process to help control the epidemic situation.
26.01.2020 – 4 Novel Coronavirus Detection products were urgently approved
28.01.2020 – 2 Nucleic Acid Detection Reagents were urgently approved
31.01.2020 – 1 Nucleic Acid Detection Reagents were urgently approved
05.02.2020 – An accumulated total of 72 medical products were urgently approved.
07.02.2020 – The urgent approval of medical protective clothing was announced
12.02.2020 – Important notes for the technical approval of Nucleic Acid Detection were announced
24.02.2020 – An accumulated total of 339 medical products and 7 Nucleic Acid Detection Reagents were urgently approved
11.03.2020 – An accumulated total of 10 Nucleic Acid Detection Reagents and 6 Antibody Detection Reagents were urgently approved
As of 05.03.2020, the CAME (China Association of Medical Equipment), a business unit under the China’s Ministry of Health, released 4 batches of urgently needed medical devices and IVDs for Coronavirus prevention and treatment, and approximately 25% of the products were produced by foreign manufacturers.
During this critical period, overseas medical products are considered to bring higher standards and innovative technologies for epidemic prevention in China. Due to this great demand, foreign manufacturers are encouraged by the Chinese government to enter the market.
