Administrative Regulations on Enterprise Implementation of the Main Responsibility for the Quality and Safety of Medical Devices

The National Medical Products Administration (“NMPA”) promulgated the Provisions on the Supervision and Administration of Enterprise Implementation of the Main Responsibility of Medical Device Quality and Safety (“Provisions”) on 29 December 2022. The Provisions will take effect as of 1 March 2023.

The Provisions are issued to further implement the Regulations on the Supervision and Administration of Medical Devices, the Regulations on the Supervision and Administration of Medical Device Manufacturing, the Regulations on the Supervision and Administration of Medical Device Trading. The Provisions aim to urge medical device registrants and record-filing applicants to implement responsibilities for medical device quality and safety, strengthen the implementation of personnel responsibilities for those personnel who take key positions and are responsible for the quality and safety in medical device manufacturing companies and in medical device trading companies.

1. Principle

According to Article 3 of the Provisions, medical device manufacturing and trading entities shall adhere to the principle that the power and responsibility shall be consistent, the responsibility shall be allocated to specific person, the selection of person shall fit the job, liability can be exempted based on performance of duties, and rewards and punishments shall have solid basis. The Provisions emphasize that medical device manufacturing and trading entities shall set key positions for quality safety and engage personnel responsible for quality safety who are compatible with the nature of medical device products and the scale of the company, and shall also provide necessary resources for such personnel and establish internal rules accordingly.

2. Requirements for Quality Safety Key Positions in Manufacturing Enterprises

a) Quality Safety Key Positions in Manufacturing Enterprises

According to Article 4 of the Provisions, quality safety key positions in manufacturing enterprises refer to the following:

b) Responsibilities of Enterprise Person in Charge

Enterprise Person in Charge shall be overall responsible for the quality safety of the medical devices manufactured by the company. Its responsibilities include without limitation (1) formulating the quality policy and quality targe of the company; (2) ensuring that there are required human resources, facilities and working environment for the effective operation of quality management system; (3) organizing and implementing review and conduct regular review on the quality management system operation status; and (4) organizing manufacturing in accordance with relevant laws, regulations, policies, good manufacturing practice, mandatory standards and product technical requirements. (Article 5 of the Provisions)

c) Designation of Management Representative

Enterprise Person in Charge of manufacturing companies shall designate at least one Management Representative among the senior management personnel. Article 6 of the Provisions stipulates the criteria for selecting such Management Representative. The Provisions reiterate some of the requirements and adjust some of the existing criteria stipulated in the Management Guide of the Management Representative of Medical Device Manufacturing Enterprise ("Management Guide", effective as of 29 September 2018).

For instance, in the Management Guide, the Management Representative for Class-II medical device manufacturing enterprises shall have a specialized degree or above at relevant specialized college or junior technical title or above, while in the Provisions, such criteria have been elevated to be bachelor's degree or above at relevant specialized college or intermediate technical title or above.

Article 8 of the Provisions emphasizes that the Enterprise Person in Charge of manufacturing companies shall conclude an authorization letter with Management Representative, the authorization letter shall set forth the quality management duties and relevant powers of the Management Representative. The Management Representative shall be reported to the local drug administration authorities within fifteen (15) working days upon designation. For those Management Representative who cannot fulfill his/her duties, the Enterprise Person in Charge shall immediately take over and fulfill such duties or designate qualified person to fulfill such duties, and shall designate a new Management Representative within thirty (30) working days.

d) Appointment of Quality Management Department Person in Charge

Manufacturing enterprises shall establish their quality management department and appoint a Quality Management Department Person in Charge. For those relatively small-scale manufacturing enterprises, the Management Representative can concurrently act as the Quality Management Department Person in Charge. (Article 9 of the Provisions)

3. Requirements for Quality Safety Key Positions in Trading Enterprises

According to Article 11 of the Provisions, quality safety key positions in trading enterprises refer to the following:

The Quality Person in Charge has the discretion in relation to quality management of medical devices and bears the quality management liabilities accordingly. The Quality Management Personnel shall assume duties in accordance with the Medical Device Good Supply Practice (effective as of 12 December 2014). Article 14 and Article 15 of the Provisions also provide the requirements for taking the position of Quality Person in Charge and Quality Management Personnel.

4. Quality Safety Management Mechanism

a) Entrusted Manufacturing

The Provisions reiterate the requirements stipulated in the Regulations on Supervision and Administration of Medical Devices ("Supervision and Administration Regulations", last revised and effective as of 1 June 2021). In case of entrusted manufacturing, registrants or record-filing applicants shall conclude a quality agreement and an entrusted manufacturing agreement with the entrusted manufacturing entity.

Article 17 of the Provisions further stipulates that before the commencement of entrusted manufacturing, registrants or record-filing applicants shall conduct an assessment on the quality assurance capability and risk management capability of the entrusted manufacturing enterprises. Although the entrusted manufacturing enterprises are statutorily required to comply with the Medical Devices Good Manufacturing Practice, the Provisions impose such responsibility on registrants or record-filing applicants so as to ensure that the entrusted manufacturing enterprises can be qualified.

After the commencement of entrusted manufacturing, registrants or record-filing applicants shall conduct on-site review of the quality management system of the entrusted manufacturing enterprise on a regular basis and ensure that there is effective connection between the quality management systems of the parties.

b) Product Release and Manufacturing Release

Article 18 of the Provisions stipulates that registrants or record-filing applicants shall establish their product release rules and standards, and the Quality Management Department Person in Charge shall organize to conduct review and approval of the medical device manufacturing process records and the quality test results. Product release shall not be entrusted to the entrusted manufacturing enterprise, who shall establish manufacturing release rules and standards.

c) Rectification and Prevention Measures, and Work Report

Article 19 of the Provisions stipulates that a medical device manufacturing entity shall establish and implement rectification and prevention measures procedures in relation to those issues detected in adverse events monitoring, user complaints, self-inspection or supervision and examination etc.

Article 21 and Article 22 of the Provisions further stipulate that the Enterprise Person in Charge of manufacturing enterprises shall listen to the work report of the Management Representative at least once every quarter and shall formulate the scheduling records on arrangement of work. The same will apply in medical device trading enterprises accordingly.

5. Quality Safety Key Positions Safeguarding Mechanism

Article 23 to Article 27 of the Provisions set forth requirements for manufacturing and trading enterprises to safeguard the quality safety key position personnel in performing of their duties. Such requirements include without limitation the following:

a) Provide training, authority and resources to those quality safety key position personnel;

b) Formulate job description of the quality safety key positions to specify the main responsibilities and duties;

c) Provide pre-employment training and continuous education and establish training records;

d) Keep record and filing of the employment, adjustment, duty performance of the quality safety key position personnel;

e) Take risk control measures once quality safety potential risks are reported by quality safety key position personnel and keep record and filing of such reports. Those quality safety key position personnel who have performed their duties by reporting such quality safety potential risks will be exempted from punishment, if the company or the Enterprise Person in Charge ignores such reporting and suggestions proposed by the quality safety key position personnel.

If drug administration authorities find out that the quality safety key position personnel have not performed his/her duties, it shall order the company to rectify within time limits. If severe unlawful acts are found, drug administration authorities shall punish the person in charge of the enterprise, the person directly responsible and other responsible personnel by way of fine or prohibition from practicing in this industry etc. in accordance with the Supervision and Administration Regulations.

Person in charge of the enterprise, the person directly responsible and other responsible personnel under the Supervision and Administration Regulations can be the Enterprise Person in Charge, Management Representative, and Quality Management Department Person in Charge under the Provisions, depending on the specific case. According to the Supervision and Administration Regulations, the above-mentioned fine can be up to three times the illegal gains that such personnel obtained from the company during the term when the unlawful acts were carried out.  

6. Preliminary Comments

To comply with the Provisions, medical devices manufacturing enterprises and medical devices trading enterprises shall improve and implement their internal processes, especially in terms of the responsibilities and duties of quality safety key position personnel. It should be noted that the Provisions raise more specific and higher requirements and criteria regarding those quality safety key positions compared to previous standards for instance the Management Guide.

Medical devices manufacturing enterprises and medical devices trading enterprises shall establish quality safety management mechanism as stipulated by the Provisions, support and safeguard the quality safety key position personnel in fulfilling their responsibilities and duties and keep good record of all the measures taken. For that purpose, medical devices manufacturing enterprises and medical devices trading enterprises shall prepare and keep documentation of the measures taken.

The Provisions imply that the compliance costs may further increase to comply with the requirements under the Provisions, for instance in terms of engaging qualified personnel for key positions, establishing internal rules specifying the duties and powers of such personnel, and preparing documentation in fulfilling the responsibilities for medical device the quality and safety.