Related Issues and Solutions to Medical Equipment Knowledge
Author：MeCan Medical–ultrasound machine manufacturersAs the policy has more and more support for domestic medical device manufacturers, many companies want to engage in the medical device industry, what standards do they need to sell to sell medical devices? What should I do? What are the provisions of the update? What are the solutions related to these medical equipment knowledge? We want to find out in detail for these questions.1. What are the qualifications to sell medical devices?One category only requires business licenses and the business scope includes medical device sales, second category to handle medical device filing vouchers, and three types of medical device business licenses.2. Which companies need to apply for medical device permits?1. Pharmacy2. Enterprises operating medical equipment3. Glasses shop (selling contact lenses)What qualifications do hospitals need to apply?Medical institution.Fourth, how many years are the medical device permit?5 years.5. What is medical device business behavior?Medical device operation refers to the behavior of providing medical device products in the form of purchase and sales, including procurement, acceptance, storage, sales, transportation, and after -sales service.6. How to replace the expiration of medical device business licenses?If the expiry of the "Medical Devices Business License" must be continued, medical device operating enterprises shall submit an application for the "Medical Device Business License" to the original certificate department 6 months before the expiry of the validity period.7. What should I do if the "Medical Device Business License" is lost?If the "Medical Device Business License" is lost, the medical device business enterprise shall immediately board the loss statement on the media designated by the original certificate department. Since the date of launching the statement, it will be applied for reissue from the original certificate department.8. What personnel do I need to apply for a medical device license?The person in charge of the corporate, the person in charge of the enterprise, the person in charge of the quality institution, the person in charge of the quality institution, and the acceptor.Nine, what are the requirements for handling medical device license venues?Ordinary two or three categories require 45 square meters, including 100 square meters of in vitro diagnostic reagents, and 130 square meters of sterile products. In addition, in vitro diagnostic reagents require a cold chain, but cold storage can be achieved through third -party logistics or self -built cold storage.10. What are medical device wholesale and retail?1. The wholesale of medical device refers to the medical device business operation of medical devices to a qualified business enterprise or using the unit.2. Medical device retail refers to the operational behavior of selling medical devices directly to consumers.11. What are the changes in the "Medical Device Business License"?The change of medical device business permits is divided into changes and changes of the license matters and changes in registration. The change of permission includes changes in operating venues, business methods, business scope, and warehouse address. The change of registration is the change of other matters other than the above items. If the license is changed, the application for changes in the "Medical Device Business License" shall be submitted to the original certificate department and submitted relevant information.12. How to store medical devices in partitional classification management?Strictly managed in accordance with the three -color classification of the Five Districts, qualified areas, shipping areas (green), to the inspection area, return area (yellow), and unqualified area (red).13. What are the qualifications for medical device network sales?Second -category medical device sales filing or medical device sales license and medical device network sales information table; if it is self -built website sales medical device, you need to obtain the "Internet Drug Information Service Qualification Certificate" in accordance with the law.14. What should the medical devices published online by the online sales of medical device networks should include?It should include names, models, specifications, structures and compositions, scope of application, medical device registration certificate number or filing voucher number, registered person or recorder information, production license or filing voucher number, product technical requirements, contraindications, etc. It should be consistent with the relevant content of registration or filing.