Regarding whether there are corresponding requirements, any industry has some standards and policies. Medical device management also has relevant laws and regulations.
According to the new policy requirements issued by hunan food and drug administration last year (20110), the registered capital, personnel, office space and warehouse area are specified. For example, the minimum registered capital requirement for operating Class II medical device products is 500,000; The minimum registered capital requirement for operating Class II and Class III medical device products is 6,543.8+0,000, and the maximum is 6,543.8+0,000. This is because the registered capital will increase according to the number of three types of products; For example, the area requirements of offices and warehouses, the second-class medical equipment products are generally 160 square meters, and houses facing the street should be used for commercial and residential purposes. For example, offices and warehouses are no longer the same and need to be on the same plane or in the same community; For another example, the minimum area of office and warehouse for products of Class II and III is 200 square meters, and the maximum area can reach 500 square meters. The area requirements here are mainly related to the three types of products operated. As for the personnel requirements, the general quality supervisor requires a bachelor degree or above, and the full-time inspectors require a college degree or above. The specific major should be determined according to the products operated. But they usually choose from the following majors: clinical medicine, bioengineering technology, physics, electronics and so on.
As for time, the policy is 60 days.
Whether there will be a new policy is uncertain. But at present, the latest policy release time in Hunan is 20 1 1 year 1 month. More information can be found in hunan food and drug administration.
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