In order to further ensure the quality and safety of new coronavirus detection reagents (including nucleic acids, antigens, and antibodies) in Guangdong Province, strengthen the quality and safety supervision of new coronavirus detection reagents, and consolidate the main responsibility of enterprises for quality and safety, the Provincial Drug Administration recently held a new coronavirus detection reagent production enterprise. At the interview meeting, a collective interview was held with the heads and managers of 12 new coronavirus detection reagent production enterprises (19 product registration certificates in total) in the province. Su Shengfeng, a first-level inspector of the Provincial Drug Administration, attended the meeting and made an interview speech.
The meeting demanded that relevant enterprises should fully understand the current situation, enhance their quality awareness, and earnestly fulfill their primary responsibility.One is to improve political standing.Enterprises should attach great importance to product quality, safety and effectiveness, fulfill their social responsibilities, and deeply understand the significance of the quality and safety of new coronavirus detection reagent products to safeguarding the overall situation of national and provincial epidemic prevention and control.The second is to do a good job of “dual coordination”.Resolutely implement the decisions and arrangements of the Party Central Committee and the State Council and the work requirements of the Provincial Party Committee and the Provincial Government, and earnestly ensure that “the epidemic must be prevented, the economy must be stabilized, and development must be safe”, and hard-won results of epidemic prevention must be consolidated.The third is to fulfill the main responsibility of the enterprise.Strengthen the quality awareness of all employees, organize production in strict accordance with the production process, product standards and technical requirements in accordance with laws and regulations, effectively strengthen the management and control of the entire production chain, and strictly control the whole process management of raw material procurement, production process, product inspection, etc., to ensure the listed products. Safe and effective; seriously carry out the monitoring and evaluation of adverse events of medical devices, conduct timely investigation, analysis, evaluation and recall of products with adverse events, and actively take effective measures to control risks.
The meeting emphasized that enterprises should resolutely hold the bottom line of quality and safety, and should not unilaterally pursue the economic interests of enterprises and relax product quality control. In the next step, the Provincial Drug Administration will combine regulatory inspections, research seminars, training presentations and other forms to publicize and implement regulations, actively promote the implementation of the “Guangdong Province Implementation Plan for Promoting the High-Quality Development of the Medical Device Industry”, and implement and optimize the second-class medical device. The 20 measures for registration review and approval will increase efforts to provide key assistance to key projects, key enterprises, and innovative medical devices, promote the high-quality development of the medical device industry, and ensure public health and safety.
At the meeting, the Provincial Drug Administration organized the representatives of the participating enterprises to sign the quality commitment letter. The enterprise has made a solemn commitment to implement the main responsibility of the enterprise, standardize production, strict inspection, and ensure the quality of new coronavirus detection reagents, resolutely prevent the occurrence of behaviors affecting product quality, and comprehensively ensure the overall situation of the province’s epidemic prevention and control and economic and social development. (Provided by the Provincial Bureau of Medical Device Supervision)