The new quality and safety regulations will be implemented from 1st March!
From：
Tech Company Date：02-15 232 Belong to：Industry Trends
At present, risk management has been widely accepted and practiced by medical device enterprises, and medical device manufacturing and operating enterprises have basically established their corresponding quality management system.
In order to further implement the requirements of regulatory laws and regulations, urge the medical device registrants and recorders to implement the main responsibilities of quality and safety, and strengthen the implementation of the responsibilities of personnel in key positions of quality and safety of medical device production and operation enterprises, the State Food and Drug Administration has formulated and issued the Supervision and Management Regulations for Enterprises to Implement the Main Responsibilities of Quality and Safety of Medical Devices, which will be implemented from March 1, 2023.
This issue brings the sorting and interpretation of the above-mentioned new regulations, and shows them through the answers to six common questions.
① What are the key positions of quality and safety?
The production enterprises include: the legal representative and principal of the enterprise, the management representative, and the head of the quality management department;
Operating enterprises include: enterprise principal, quality principal and quality management personnel.
② What are the special requirements for the management representative appointed by the enterprise?
1. They should be full-time employees of their enterprises;
2. No bad employment record;
3. Be familiar with and able to correctly implement the requirements of relevant laws, regulations, rules, specifications and standards, and have received systematic quality management system knowledge training;
4. Have corresponding education background, professional title and work experience.
③ Can the management representative and the head of the quality management department be the same person?
The management representative is the senior management, and the head of the quality management department is generally the middle management.
Small-scale enterprises may, according to the actual situation, have the management representative concurrently serve as the head of the quality management department.
④ Does the appointment of the management representative need to be filed with the regulatory authority? When is it necessary to appoint a new management representative?
Report to the local drug supervision and administration department within 15 working days after determining the management representative.
For the management representative who fails to perform his/her duties effectively, the person in charge of the enterprise shall immediately perform his/her duties on his/her behalf, or appoint a qualified person to perform the duties of the management representative on his/her behalf, and determine and appoint a new management representative within 30 working days.
⑤ In combination with the registrant system, how should product release be managed?
The registrant and the registrant shall establish the product release procedures for marketing, and the head of the quality management department shall organize the review of the medical device production process records and quality inspection results.
The release of products from the market shall not be entrusted to the entrusted manufacturing enterprise.
The entrusted manufacturing enterprise shall establish production release procedures, and the head of the quality management department shall organize the review of the production process of medical devices and the inspection of products.
⑥ Does the internal quality and safety of the enterprise need regular communication?
The person in charge of the production enterprise shall listen to the work report of the management representative at least once a quarter, and form the dispatching record.
The person in charge of the operating enterprise shall listen to the work report of the person in charge of quality at least once a quarter to form the minutes of the medical device quality and safety risk conference.
In order to further implement the requirements of regulatory laws and regulations, urge the medical device registrants and recorders to implement the main responsibilities of quality and safety, and strengthen the implementation of the responsibilities of personnel in key positions of quality and safety of medical device production and operation enterprises, the State Food and Drug Administration has formulated and issued the Supervision and Management Regulations for Enterprises to Implement the Main Responsibilities of Quality and Safety of Medical Devices, which will be implemented from March 1, 2023.
This issue brings the sorting and interpretation of the above-mentioned new regulations, and shows them through the answers to six common questions.
① What are the key positions of quality and safety?
The production enterprises include: the legal representative and principal of the enterprise, the management representative, and the head of the quality management department;
Operating enterprises include: enterprise principal, quality principal and quality management personnel.
② What are the special requirements for the management representative appointed by the enterprise?
1. They should be full-time employees of their enterprises;
2. No bad employment record;
3. Be familiar with and able to correctly implement the requirements of relevant laws, regulations, rules, specifications and standards, and have received systematic quality management system knowledge training;
4. Have corresponding education background, professional title and work experience.
③ Can the management representative and the head of the quality management department be the same person?
The management representative is the senior management, and the head of the quality management department is generally the middle management.
Small-scale enterprises may, according to the actual situation, have the management representative concurrently serve as the head of the quality management department.
④ Does the appointment of the management representative need to be filed with the regulatory authority? When is it necessary to appoint a new management representative?
Report to the local drug supervision and administration department within 15 working days after determining the management representative.
For the management representative who fails to perform his/her duties effectively, the person in charge of the enterprise shall immediately perform his/her duties on his/her behalf, or appoint a qualified person to perform the duties of the management representative on his/her behalf, and determine and appoint a new management representative within 30 working days.
⑤ In combination with the registrant system, how should product release be managed?
The registrant and the registrant shall establish the product release procedures for marketing, and the head of the quality management department shall organize the review of the medical device production process records and quality inspection results.
The release of products from the market shall not be entrusted to the entrusted manufacturing enterprise.
The entrusted manufacturing enterprise shall establish production release procedures, and the head of the quality management department shall organize the review of the production process of medical devices and the inspection of products.
⑥ Does the internal quality and safety of the enterprise need regular communication?
The person in charge of the production enterprise shall listen to the work report of the management representative at least once a quarter, and form the dispatching record.
The person in charge of the operating enterprise shall listen to the work report of the person in charge of quality at least once a quarter to form the minutes of the medical device quality and safety risk conference.
