Medical device manufacturing enterprises (hereinafter referred to as enterprises) shall be in accordance with the "medical device production quality management standards" (China Food and Drug Administration announcement

20 14 64), determine a management representative, clarify the responsibilities of the management representative, standardize the management of the management representative, and ensure the scientific, reasonable and effective operation of the quality management system.

I. Scope of application

This guide is applicable to the management of management representatives of medical device manufacturing enterprises.

The management representative referred to in this guide refers to the member determined by the person in charge of the enterprise among the senior management personnel, who is responsible for establishing, implementing and maintaining the quality management system, reporting the operation and improvement requirements of the quality management system, and improving the employees' awareness of meeting laws, regulations and customer requirements.

Second, the management representative office

(A) the responsibilities of the management representative

The management representative shall have a sense of medical device quality and responsibility, give priority to meeting the requirements of laws and regulations and product quality and safety, and perform his duties in a realistic and principled manner to ensure the safety and effectiveness of medical devices produced by enterprises.

Authorized by the person in charge of the enterprise, the management representative shall perform the following duties in the enterprise quality management activities:

1. Implement laws, regulations, rules and standards related to medical devices.

2. Organize the establishment and implementation of a quality management system suitable for the medical devices produced, and maintain its scientific, reasonable and effective operation, and report the operation and improvement requirements of the quality management system to the person in charge of the enterprise.

3. Formulate and organize the implementation

Enterprise quality management system audit plan, assist the person in charge of the enterprise to organize management review as planned, prepare audit report, and report the results to the enterprise management.

4. Organize internal medical device quality management training, improve the quality management ability of employees, and strengthen the awareness of corporate integrity and law-abiding.

5 production enterprises accept the supervision and inspection of drug supervision and management departments at all levels, keep in touch with the inspection team, provide relevant information and materials, and cooperate with the inspection work; In view of the problems found in the inspection, organize the relevant departments of the enterprise to make timely rectification as required.

6. When the production conditions of an enterprise no longer meet the requirements of the medical device quality management system, which may affect the safety and effectiveness of medical devices, it shall immediately report to the person in charge of the enterprise, assist the person in charge of the enterprise to carry out risk control measures such as stopping production activities, investigating the reasons and recalling products in time, and actively report to the local drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government.

7. When the medical devices produced by enterprises have serious quality problems, they shall immediately report to the person in charge of the enterprise, assist the person in charge of the enterprise to take risk control measures quickly, and report to the local drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government within 24 hours.

8. Organize the information collection of product quality after listing, and report to the person in charge of the enterprise the defects of the quality management system and their rectification found in the external audit of product complaints, adverse event monitoring, product safety hazards and supervision and inspection of drug supervision and management departments at all levels.

9. In accordance with the requirements of the Quality Management Standard for Medical Device Production, organize enterprises to conduct comprehensive self-inspection on the operation of the quality management system on a regular basis, and submit annual self-inspection reports to the local drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government before the end of each year.

10. Work specified by other laws and regulations.

(2) Qualification of the management representative

The management representative shall be a formal employee of the enterprise and meet the following conditions:

1. Be law-abiding, have good professional ethics, and have no bad work record.

2. Familiar with and able to correctly implement the relevant national laws, regulations and rules, and have been trained in the relevant laws, regulations and standards of medical devices.

3. Have YY/T 0287(ISO 13485) or GB/T19001(ISO 9001) internal auditor certificate, or have received the same level of systematic quality management system knowledge training.

4. Be familiar with the quality management of medical device production, and have the professional skills and the ability to solve practical problems to guide or supervise all departments of the enterprise to implement the "Quality Management Standards for Medical Device Production" as required.

5. Have good organization, communication and coordination skills.

6. Deputy General Manager of the enterprise or other senior management personnel of the enterprise.

7. The management representative of the third kind of medical device manufacturing enterprise shall have a bachelor degree or above in medical device-related major or an intermediate technical title or above, and have more than 3 years of experience in quality management or production technology management; The management representative of the second kind of medical device manufacturing enterprises shall have a college degree or above in medical device-related major or a junior technical title or above, and have more than 3 years of experience in quality management or production technology management; In principle, the management representative of a class of medical device manufacturing enterprises should have a college degree or above and have more than 3 years working experience in medical device manufacturing enterprises.

have

With more than 5 years working experience in medical device quality management or production technology management, familiar with the product, production and quality management of the enterprise, and proved to have good performance ability by practice, the management representative may appropriately relax the requirements of relevant academic qualifications and professional titles.

8. Other conditions required for performing duties.

After taking office, management representatives should continue to strengthen knowledge updating, actively participate in various learning and training activities that are conducive to improving the quality management ability of enterprises, grasp relevant laws and regulations in time, and continuously improve the quality management level.

Third, the management of the management representative

(A) the management of management representatives by enterprises

The enterprise shall determine the candidate for the management representative according to this guide, and the person in charge of the enterprise and the management representative shall sign a power of attorney to clarify the quality management responsibilities that the management representative should perform and grant the corresponding authority. The enterprise shall determine the management representative.

/kloc-report to the local pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the central government within 0/5 working days.

Enterprises should establish and improve the relevant management system and assessment mechanism of management representatives, strengthen the management of enterprise quality system, provide necessary conditions for management representatives to perform their duties, and ensure that they are not unduly interfered by internal factors in the enterprise when performing their duties. For the management representative who cannot effectively perform his duties, the person in charge of the enterprise shall immediately perform the duties of the management representative on his behalf, and

Identify and appoint a new management representative within 30 working days.

If the management representative fails to perform his statutory duties, neglects his duties or neglects his duties, resulting in one of the following circumstances, the enterprise shall investigate the work responsibilities of the management representative and report to the local drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government:

1. There are serious defects in the enterprise quality management system;

2. Major medical device quality accidents occur;

3. Practicing fraud in the implementation of medical device quality system;

4. The information reported by the management representative is untrue;

5. Other acts in violation of laws and regulations related to medical devices.

(b) Management of management representatives by regulatory agencies

The pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall establish the files of managers' representatives, add the information of managers' representatives to the daily supervision files of enterprises, and strengthen the inspection of the on-the-job performance, performance and training of enterprise managers' representatives in daily supervision.

If the enterprise fails to appoint a management representative according to the regulations or the appointed management representative does not meet the requirements, the pharmaceutical supervisory and administrative department shall interview the person in charge of the enterprise. If the management representative fails to perform his duties effectively, which leads to one of the situations mentioned in the third paragraph of Item (1) of Article 3, the enterprise shall be ordered to make rectification, and it shall be included as an important reference factor for the scoring and assessment of enterprise quality credit management in that year; If the circumstances are serious, the pharmaceutical supervisory and administrative department of the province, autonomous region or municipality directly under the Central Government where the production enterprise is located shall notify it and disclose the information in accordance with relevant regulations. The pharmaceutical supervisory and administrative department shall deal with enterprises in accordance with the relevant provisions of laws and regulations, and strengthen supervision.