Medical Device Class II Qualification

I. Class II medical device qualification content

Compared with other types of medical device qualification, Class II medical devices are more dangerous, every detail should be strictly managed and reviewed. For example, some blood pressure needles and other devices, you must obtain the necessary purchase production qualifications, in order to sell and buy. So try to advance to the industrial and commercial departments for the qualification of Class II medical devices for the record, to be able to obtain a license as soon as possible to promote to the market for sale.

Second, the conditions in the storage place

In addition to the qualification of Class II medical devices for the record, there are also considerations of some of the good storage place, for Class II medical devices, not the general ordinary products, but some of the special products on the medical industry. If possible, put in a more tightly sealed warehouse, if the enterprise has some storage difficulties, to timely entrust the third party logistics to help.

Third, with the relevant system and the scope of standards

Different types of medical devices have different levels of qualification, the relevant standards are also different. Because Class II medical devices are more dangerous, so its qualification requirements are more, to have a more complete management system standards. Need to pay attention to equipped with technical management capabilities and security services to help the company to make the qualification of Class II medical devices to be satisfied.

Through the above understanding of the relevant aspects of the qualification of Class II medical devices, I believe we have obtained some of the relevant qualification requirements, if you want to do business, try to review the various aspects.