Jilin food and drug administration stipulates that

2022-08-18
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Jilin food and drug administration stipulates to apply for monthly inspection of blood bags

it is reported that Jilin food and Drug Administration recently issued a notice requiring enterprises producing disposable plastic blood bags to implement a monthly inspection system

as a product of the catalogue of national key regulated medical devices, the quality of disposable plastic blood bags is directly related to the safety of medical blood. For this reason, Jilin food and drug administration stipulates that the production enterprise should report its production batch, output of each batch, ex factory inspection results, ex factory quantity of each batch, sales object and contact information of sales object to the municipal and State Food and Drug Administration in writing at the end of each month. At the same time, its Qingdao Institute of bioenergy and process recently encouraged enterprises to accelerate the pace of technological transformation and successfully developed new polyurethane materials, and ordered the municipal and State Drug Administration to strengthen the supervision and management of production, operation and use units within its jurisdiction to ensure the safety and effectiveness of listed products

if the discontinued enterprise wants to resume production, it should be tested and qualified by the monitoring department designated by the provincial food and drug administration. The first batch of products produced should be sampled by the local food and Drug Administration and sent to the legal medical device testing department designated by the State Food and Drug Administration for testing and qualified. The products can be sold only after the Jilin food and drug administration has passed the quality system assessment on the production site in accordance with the production implementation rules

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