Medical device manager's representative

Medical

medical device manufacturers (hereinafter referred to as enterprises) should be in accordance with the "Quality Management Standards for the Manufacture of Medical Devices" (State Food and Drug Administration Announcement

No. 64 of 2014) requirements, to determine a management representative, a clear management representative of the responsibilities of the management representative, standardize the management of the management representative, to ensure that the quality management system is scientific, rational and effective operation.

First, the scope of application

This guide applies to the management of medical device manufacturers on behalf of the management.

The manager's representative referred to in this guide refers to the person in charge of the enterprise in the senior management personnel to determine a member, responsible for the establishment, implementation and maintenance of the quality management system, reporting on the operation of the quality management system and the need for improvement to improve staff to meet the laws and regulations and customer requirements of the awareness.

Second, the post of the manager's representative

(a) the duties of the manager's representative

The manager's representative should have a sense of quality of medical devices and awareness of the responsibility to meet the requirements of the regulations and product quality and safety in the first place to seek truth from facts and adhere to the principles of the attitude to perform their duties to ensure that the production of medical devices in the enterprise safety, effective.

The manager's representative should be in the enterprise quality management activities, authorized by the person in charge of the enterprise, to perform the following duties:

1. Implementation of medical devices related laws, regulations, rules and standards.

2. Organize the establishment and implementation of the production of medical devices and the production of appropriate quality management system, and to maintain its scientific, rational and effective operation, to the person in charge of the enterprise to report on the operation of the quality management system and the need for improvement.

3. Develop and organize the implementation of

enterprise quality management system audit plan, to assist the person in charge of the enterprise according to the plan to organize the management review, the preparation of audit reports and report to the management of the enterprise review results.

4. Organize internal medical device quality management training to improve the quality management capabilities of employees, and strengthen the integrity of the enterprise awareness of compliance.

5. In the production of enterprises to accept the supervision and inspection of the drug supervision and management departments at all levels, to maintain communication with the inspection team, provide relevant information, data, and cooperate with the inspection work; for the inspection of the problems found, the organization of the relevant departments of the enterprise in accordance with the requirements of timely rectification.

6. When the production conditions of the enterprise no longer meet the requirements of the quality management system of medical devices, may affect the safety of medical devices, effective, should be immediately reported to the person in charge of the enterprise, to assist the person in charge of the enterprise in a timely manner to carry out the production activities to stop the investigation of the causes of the product recall and other risk control measures, and to take the initiative to the location of the provincial, autonomous regions, municipalities directly under the central drug supervision and management department report.

7. When the production of medical devices in the event of major quality problems, should be immediately reported to the person in charge of the enterprise, to assist the person in charge of the enterprise to quickly take risk control measures, and within 24 hours to the local provinces, autonomous regions, municipalities directly under the central drug supervision and management department report.

8. Organizations after the listing of product quality information collection, timely report to the enterprise responsible for product complaints, adverse event monitoring, product safety risks, as well as acceptance of all levels of supervision and management of drug supervision and management departments to monitor and inspect the external audit found in the quality management system deficiencies and their rectification.

9. Regularly organize the enterprise in accordance with the "Good Manufacturing Practice for Medical Devices" requirements of the quality management system to carry out a comprehensive self-examination of the operation, and at the end of each year to the location of the provincial, autonomous regions, municipalities directly under the central drug supervision and management departments to submit an annual self-examination report.

10. Other laws and regulations of the work.

(B) the manager's representative of the conditions

The manager's representative should be in the enterprise's full-time employees, and meet the following conditions:

1. Compliance with the law, with good ethical qualities and no bad practice records.

2. Familiar with and able to correctly implement the relevant state laws, rules and regulations, through the medical device related regulations, standards and other aspects of training.

3. Have YY/T 0287 (ISO 13485) or GB/T19001 (ISO9001) internal auditor certificate, or received the same level of systematic quality management system knowledge training.

4. Familiar with the production of medical devices quality management, with the guidance or supervision of the enterprise departments in accordance with the provisions of the implementation of the "production of medical devices quality management standard" professional skills and the ability to solve practical problems.

5. Good organizational, communication and coordination skills.

6. Deputy general manager of the enterprise or other senior management of the enterprise.

7. Class III medical device manufacturer management representative should have a medical device-related bachelor's degree or above, or intermediate or above, and has more than 3 years of experience in quality management or production, technical management; Class II medical device manufacturer management representative should have a medical device-related bachelor's degree or above, or junior technical title, and has more than 3 years of experience in quality management or production, technical management. Quality management or production, technical management experience; Class I medical device manufacturer management representative should in principle have a college degree or above, and has more than 3 years of medical device manufacturer work experience.

With

5 years of experience in quality management or production of medical devices, technical management, familiar with the products, production and quality management of the enterprise, proven to have a good ability to fulfill the duties of the management of the representative, may be appropriate to relax the relevant academic and professional title requirements.

8. Other requirements necessary to fulfill their duties.

Management representatives should also continue to strengthen the post knowledge update, and actively participate in all kinds of learning and training activities to improve the quality of enterprise management capabilities, timely mastery of relevant laws and regulations, and continuously improve the level of quality management.

Third, the management of the management representative

(a) the management of the management representative of the enterprise

Enterprises should be in accordance with this guide to determine the management representative of the candidate, the person in charge of the enterprise and the management of the representative of the authorization signed by the representative of the management of a clear management representative should perform the duties of quality management and the granting of the corresponding authority. Enterprises should determine the management representative 15 working days to the location of the provincial, autonomous regions, municipalities directly under the Central Drug Administration report.

Enterprises should establish and improve the management system and assessment mechanism, strengthen the enterprise quality system management, to provide the necessary conditions for the representatives of the management to perform their duties, while ensuring that their duties in the performance of the internal factors from the enterprise without undue interference.

Management representatives do not fulfill their statutory duties, negligence, dereliction of duty, resulting in one of the following circumstances, the enterprise shall be held responsible for the work of the management representative, and to the local provinces, autonomous regions, municipalities directly under the Central Drug Administration department report:

1. Medical device quality system implementation work in the fraud;

4. Managers on behalf of the report information is not true;

5. Other violations of laws and regulations related to medical devices.

(B) the regulatory authorities on the management of the management representative

provinces, autonomous regions, municipalities directly under the Central Drug Administration should establish the management representative file, in the daily supervision of the enterprise file to join the management representative of the information in the day-to-day supervision should be strengthened in the management of the enterprise on duty, fulfill their duties and accept the training of the situation of the inspection.

The enterprise did not appoint the required management representative or appointed management representative does not meet the requirements of the drug supervision and management department shall interview the person in charge of the enterprise. On behalf of the management can not effectively perform their duties, resulting in three (a) the third paragraph of one of the circumstances described in the third paragraph, should be ordered to rectify the enterprise, and included in the enterprise quality credit management rating of the year an important reference factor; the circumstances are serious, by the production of the enterprise's location in the provinces, autonomous regions and municipalities directly under the Central Drug Administration for notification and disclosure of information in accordance with the relevant provisions. Drug supervision and management departments should be in accordance with the relevant provisions of laws and regulations of the enterprise to deal with, and strengthen supervision.