The following is based on the regulations of Guangdong and Hunan provinces as a reference:
On-site inspection record of medical device business license in Guangdong Province
1 The person in charge and quality manager of the enterprise shall be familiar with the laws and regulations on the supervision and administration of medical devices and the relevant provisions of the food and drug supervision and administration department on the supervision and administration of medical devices.
The person in charge of the enterprise should have a college degree or above. The quality manager should have a college degree or above in medical device related major and 1 year or above relevant working experience, and earnestly perform his post responsibilities. The person in charge of the enterprise and the quality manager shall not concurrently serve each other.
A sound enterprise organization should set up posts in quality management, acceptance, storage management, purchase and sale, after-sales service and computer management. , and adapt to the scale and scope of business, according to the post setting equipped with medical equipment related professional college degree or above professional and technical personnel, professional and technical personnel of not less than 8 people.
The quality manager has the right to decide the quality of medical devices during operation. Enterprises with business categories above 10 should set up full-time quality management institutions with at least 2 people, including quality managers.
Enterprises should have professional and technical personnel in charge of quality management, acceptance, storage management, purchase and sale, after-sales service, computer management and other positions, and should have a college degree or above in medical device related majors, with a total number of not less than 8 people.
6 quality management personnel and professional and technical personnel should be on-the-job, not part-time. Should sign a legal and effective labor contract with the company, with the employment of enterprise personnel.
7. The person in charge of the enterprise, the quality manager, the person in charge of sales and professional and technical personnel shall be trained and qualified before taking up their posts. Enterprises should regularly organize training or continuing education for the above-mentioned personnel in medical device laws and regulations, professional knowledge, internal system and professional ethics, and establish relevant files.
Enterprises should organize quality management personnel and professional and technical personnel to carry out health examination and establish files every year. Persons suffering from infectious diseases and skin diseases shall not engage in direct contact with medical devices.
Professional and technical personnel in enterprise computer management positions are responsible for maintaining enterprise computer management information system and submitting electronic supervision information on medical device operation.
On-site inspection and acceptance standard of medical device management enterprises (stores) in Hunan Province
1. 1 The person in charge of the enterprise should have a technical secondary school education or a junior professional title. Understand the national laws, regulations and normative documents related to the supervision and management of medical devices. The person in charge of the enterprise shall not concurrently be the person in charge of quality or full-time quality management personnel.
1.2 An enterprise shall set up a leading organization for quality management, including: main person in charge, person in charge of quality management, person in charge of procurement, sales, storage and transportation, etc. Medical device practitioners should participate in the training of medical vocational skills appraisal and obtain the qualification of primary workers or above.
1.3 An enterprise shall have a quality management organization or full-time quality management personnel suitable for its business scale. Enterprises engaged in medical devices should have relatively independent organizations (such as medical device management departments), with designated department heads, full-time quality management personnel and quality acceptance personnel. The headquarters of a chain operation enterprise shall set up a quality management organization, designate the person in charge of the quality management organization, and the branch shall designate 1 quality management personnel. Enterprise quality management personnel should have a college degree or above in medical device-related majors or intermediate titles, and be familiar with medical device management regulations and technical standards of products they operate. Have certain practical experience and ability to solve quality problems in business process. Hearing aid enterprises should at least be equipped with technicians with primary hearing testing professional qualifications. Enterprises engaged in home physiotherapy and rehabilitation equipment must be equipped with 1 medical professional and technical personnel with college or above or intermediate titles if they have experience places. Quality management personnel should be on-the-job, not part-time in other enterprises.
1.4 Enterprises should establish employee files. Files include: resume, copy of education certificate, copy of identity certificate, employment letter, employment letter, labor contract, training record, assessment results, etc. Personnel who come into direct contact with aseptic equipment should hold valid health certificates.
1.5 medical device product sales personnel should have a high school education or above and have been trained in the professional knowledge of the products they sell. For enterprises that operate home physiotherapy rehabilitation equipment, the interpreters who experience the on-site explanation system should have medical professional knowledge and a written explanation of the teaching plan.
1.6 The enterprise shall formulate a training plan, and regularly train employees in laws and regulations, professional technology, quality management and after-sales service knowledge, and the training results shall be recorded in personal files.