1, the business approach to business quality management requirements?
A: First, strengthen the enterprise quality responsibility. Requirements of the enterprise in accordance with the requirements of the medical device business quality management standards, the establishment of quality management covering the whole process of business management system, to ensure that the operating conditions and business practices continue to meet the requirements. At the same time, the self-inspection and reporting system has been put forward for enterprises operating Class III medical devices. Secondly, it pays more attention to the quality management of the whole process of operation. Strictly control the qualification audit of the procurement and sales links to ensure the legitimate circulation of medical devices; highlight the purchase inspection, sales link record requirements to ensure product traceability; emphasize the storage and transportation requirements for low-temperature, refrigerated medical devices, to ensure the quality of product transportation; the after-sales service requirements of the operating companies to ensure the safety of the use of the product.
2, for other medical device manufacturers and operators to provide storage, distribution services business enterprises should have what conditions?
Answer: For other medical equipment production and management enterprises to provide Class II, Class III medical device storage, distribution services of medical equipment business enterprises, should obtain a medical device license or record certificate. At the same time, it should sign a written agreement with the commissioning party to clarify the rights and obligations of both parties, and with the product storage and distribution conditions and scale of equipment and facilities, with the commissioning party to carry out real-time electronic data exchange and the realization of the whole process of product management can be traced back to the computer information management platform and technical means.
Medical device business enterprises should provide storage, distribution services for medical devices business enterprises to provide. Storage, distribution services quality assurance capabilities for assessment and evaluation, clear quality responsibility in the transportation process, to ensure the quality and safety of the transportation process.
3, the first class of medical equipment business enterprises should have what conditions?
A: The operation of Class I medical devices do not need to apply for licensing and record-keeping. But engaged in the first class medical device business should meet the following requirements: First, it should have with the scale and scope of operation of the business premises and storage conditions. Second, with the operation of medical devices and quality management system and quality management organization or personnel.
4, medical equipment wholesale, retail enterprises, what is the difference?
A: medical device wholesale and retail according to the different sales targets and different. Medical device wholesale, refers to the sale of medical devices to qualified medical equipment business enterprises or the use of units of business behavior. Medical device retail, is the direct sale of medical devices to consumers of business behavior.
5, what are the special requirements for the operation of Class III medical devices?
A: the business of Class III medical devices should have the following requirements: First, should obtain a medical device license. Secondly, it should have a computerized information management system that meets the quality management requirements of medical device business to ensure the traceability of business products. Third, it should establish a sales record system and establish a quality management self-inspection system. Fourth, the self-stopping more than one year, re-opening, should be reported in advance in writing to the municipal food and drug supervision and management departments, the verification of compliance with the requirements before resuming business.
6, the medical device business enterprise separation, merger and what procedures need to be applied?
A: engaged in the third class of medical equipment business enterprises due to separation, merger and survival, should apply for a change of license; due to business separation, merger and dissolution of the business should apply for cancellation of the "Medical Device License"; due to business separation, merger and the establishment of a new business, should apply for the "Medical Device License".
7, medical device registrants, filers or manufacturers of medical equipment sales what provisions?
A: medical device registrants, filers or manufacturing enterprises in its residence or production address sales of self-produced medical devices, do not need to apply for a license or record; in other places of storage and spot sales of second and third class medical devices, should be in accordance with the provisions of the business license or record.
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