One of the conditions for the medical device business license: with the scale and scope of operation of the quality management organization or full-time quality management personnel. Quality management personnel should have a nationally recognized professional qualifications or titles.
The medical device license conditions of the second: with the scale and scope of operation of relatively independent business premises.
The third condition for the medical device license: with the scale and scope of operation of the storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of medical devices.
Fourth for the medical device license conditions: should establish and improve product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and adverse event reporting system.
The fifth condition for the medical device license: should have the ability to provide technical training and after-sales service appropriate to the medical device products it operates, or agreed to provide technical support by a third party.
Au Aida Medical Devices Consulting Co., Ltd. reminds: for medical device license must be through the food and drug supervision and management department's inspection and acceptance. Provinces, municipalities, autonomous regions, municipalities directly under the Central Food and Drug Administration should be based on the "Medical Device Business License Management Measures", combined with the actual situation in the administrative region, the development of appropriate medical device business inspection and acceptance criteria, reported to the State Food and Drug Administration for the record.
The application for registration of medical device manufacturing license is a very complicated process, the details of the many problems, if you are new to this line, we recommend that you go to the Aojida medical device consulting agency to consult the details, where the teacher will guide you one by one to help you take the road less traveled.