(10 September, 2020, Shanghai) Recently, Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma” or “Group”; Stock Symbol: 600196.SH, 02196.HK) announced that the Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit (“the Kit”) self-developed by its wholly-owned subsidiary, Shanghai Fosun Long March Medical Science Co., LTD (“Fosun Long March”) was officially included in the World Health Organization (WHO) Emergency Use Listing (EUL).
Previously, the Kit has received the medical device registration certificate issued by the China National Medical Products Administration (NMPA) and was granted CE certification from the European Union (EU), Emergency Use Authorization (EUA) from U.S. Food and Drug Administration (FDA) and certification from Therapeutic Goods Administration (TGA).
The Novel Coronavirus nucleic acid detection kit self-developed by Fosun Long March is one of the Novel Coronavirus detection products with reliable performance and high degree of automation on the market. This kit can realize qualitative detection of Novel Coronavirus RNA targeting for its specific ORF1ab, N and E gene, and can complete the detection of 96 samples within two hours by supporting fast automatic nucleic acid extraction instrument and extraction reagents. In addition, automated testing will lower the risk of operator infection, reduce the probability of cross contamination in the clinical laboratory, and improve detection efficiency.
On January 30, 2020, WHO announced the Novel Coronavirus outbreak as a public health emergency of international concern and initiated EUL, an in-vitro diagnostic reagent to test Coronavirus. Products approved by WHO for emergency approval will be included in EUL to provide references for diagnostic products procurement by WHO, agencies of the United Nations and other international, regional or national procurement agencies.
As one of the leading enterprises in the field of in-vitro diagnosis in China, Fosun Long March has been actively exerting its research and development advantages, integrating various resources, and continuously contributing to the prevention and control of the epidemic since the outbreak of the epidemic. Now the Kit has been exported to more than 10 countries, like Portugal, Hungary, Belgium, France and Germany to meet the needs of the global epidemic prevention. After the Kit has been included in WHO EUL, Fosun Long March will keep providing products and services for the anti-epidemic work in Africa and other countries.
Unfortunately, it is NOT legal unless the manufacturers have branches with qualification in China to deal with the registration issues. Otherwise, it is a must-do that manufacturers overseas are required to appoint a Chinese agent for the medical device registration.
Regarding the registration fee for NMPA, as for the imported medical devices, the registration of Class II medical device needs 210,900 CNY while that of Class III costs 308,800 CNY. In addition, other kinds of possible fees should be taken into consideration such as fees of document translation, clinical trial, and so forth.
After the registration materials are accepted by NMPA, technical review for Class II medical devices takes 60 working days to process while for Class III medical devices, technical review takes 90 working days. If supplementary materials are required by NMPA, manufacturers are obliged to conduct submission within one year, otherwise the review may result in termination.
MDs with CE or FDA certificate are feasible to enter SAR without NMPA certificate. As for the Greater Bay Area and Hainan province, MDs marketed in HK or MO as a premise can enter the pilot areas if designated medical institutions in pilot areas are willing to procure medical devices out of clinical urgent needs under the approval of local government.
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