The following provisions in Guangdong and Hunan provinces as a reference:
Guangdong "medical device business license" on-site inspection record sheet
1 The person in charge of the enterprise, the quality management should be familiar with the supervision and management of medical devices, laws and regulations, as well as food and drug supervision and management departments of the supervision and management of medical devices and the relevant provisions.
2The person in charge of the enterprise shall have college degree or above. Quality management should have medical device related professional college degree or above and more than 1 year of relevant work experience, and effectively fulfill their job responsibilities. The person in charge of the enterprise and the quality management shall not be concurrent with each other.
3 sound organizational structure, should be set up with the scale and scope of operation of the quality management, acceptance, warehouse management, purchase and sale, after-sales service, computer management and other positions, and according to the job setup with medical equipment related professional and technical personnel with college education, the number of professional and technical personnel of not less than 8 people.
4 quality manager in the business process of the quality of medical devices have the right to rule. Operating more than 10 categories of enterprises should be set up, including quality management, not less than two full-time quality management organization.
5 Enterprises should have with the scale and scope of business operations in charge of quality management, acceptance, warehouse management, purchasing and marketing, after-sales service, computer management and other positions of professional and technical personnel, and should have medical device-related professional college degree or above, the total number of not less than 8 people.
6 Quality management personnel and professional and technical personnel should be on duty, not part-time. Should sign a legal and effective labor contract with the company, with corporate personnel appointment letter.
7 The person in charge of the enterprise, the quality manager, the person in charge of sales and the professional and technical personnel shall be trained and qualified before taking up their duties. Enterprises should be regularly organized for the above personnel for medical device laws and regulations, regulations, professional knowledge, internal systems, professional ethics training or continuing education, and the establishment of relevant files.
8 Enterprises should be organized annually quality management personnel and professional and technical personnel to carry out health checks and establish files. Suffering from infectious diseases, skin diseases shall not be engaged in direct contact with medical devices.
9 enterprise computer management positions of professional and technical personnel, responsible for maintaining the enterprise's computer management information system as well as medical device business electronic regulatory information reporting.
Hunan medical device business enterprises (stores) on-site inspection and acceptance criteria
1.1 The person in charge of the enterprise shall have secondary school education or above or junior title. Understand the national supervision and management of medical devices regulations, rules and normative documents. The person in charge of the enterprise shall not also be the person in charge of quality or full-time quality management personnel.
1.2 Enterprises should set up quality management leadership organization, including: the main person in charge, quality management, import, sales and storage and transportation and other business leaders. Medical device practitioners should participate in the pharmaceutical vocational skills assessment training, to obtain the qualification of junior workers or above.
1.3 Enterprises should have a quality management organization or full-time quality management personnel appropriate to the scale of operation. Part of the medical device enterprises should be relatively independent of the organization (such as medical equipment, etc.), there are designated department heads, full-time quality management personnel and quality acceptance of personnel. The headquarters of the chain of enterprises should set up quality management organization, appoint the person in charge of the quality management organization, the branch should be clear 1 quality management personnel. Enterprise quality management personnel should have college degree or above in medical device related majors or intermediate title or above, familiar with medical device management regulations and technical standards of the products operated. Have certain practical experience and the ability to solve quality problems in the business process. Enterprises operating hearing aids should be equipped with at least one technician with primary hearing test professional qualifications. Enterprises operating household physical therapy and rehabilitation equipment, with experience places, shall be equipped with 1 college or above or intermediate title of medical professional and technical personnel. Quality management personnel shall be on duty and shall not work part-time in other enterprises.
1.4 Enterprises shall establish employee files. Files include: personal history, copies of academic certificates, copies of identity certificates, appointment letters, employment letters, labor contracts, training records, test scores, etc., direct contact with sterile devices should be on duty with a valid health certificate.
1.5 Medical device product sales staff should be above high school education and specialized knowledge of the products sold through training. Businesses operating household physical therapy and rehabilitation equipment, "experience places to explain the system" explaining the staff should have medical expertise, and have a written explanation of the lesson plan.
1.6 Enterprises should develop training programs, regular training of staff regulations, professional and technical, quality management, after-sales service knowledge, training results are recorded in personal files.