SINGAPORE--China's FDA has issued the country's first GSP (Good Supply Practices) rules that will cover 1, 2 and 3 medical device distributors, as it moves to harmonize practices followed elsewhere in the world and rein in service providers of medical devices that may not have detailed technical expertise.
The regulations set minimum standards for device procurement, delivery acceptance, storage, sales, transportation, and after-sales services. Distributors are required to implement quality management systems covering distribution, including training personnel, cold storage and cold-chain transportation and keep detailed electronic records.
- here's the regulation (in Chinese)
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