What You Must Know About the Commissioned Production of Medical Devices

Article 34 of the Regulations on the Supervision and Administration of Medical Devices (2021 Edition) stipulates that medical device registrants and filers may produce medical devices by themselves, or they may entrust enterprises that meet the provisions of these regulations and have corresponding conditions to produce medical devices. This is

also the most authoritative legal meaning of entrusted production of medical devices. So, what should we know in the process of entrusted production?

First of all, which medical devices can be contracted for production?　　

The new version of the Regulations stipulates implantable medical devices with high-risk shall not be commissioned for production. In March 2022, the NMPA issued the “Notice on Issuing the Catalogue of Medical Devices Prohibited from Entrusted Production (No. 17 of 2022), which specifically lists the categories of products that are prohibited from entrusted production, as follows:

I. Active medical devices: implantable cardiac pacemaker (12-01-01), implantable cardiac contractility regulator (12-04-01), implantable circulatory assist device (12-04-02).

II. Passive implantable medical devices: dura (spinal) membrane patch (excluding products without animal-derived materials) (13-06-04), intracranial stent system (13-06-06), intracranial Aneurysm blood flow guide device (13-06-11), cardiovascular implant (except peripheral vascular stent, vena cava filter, cardiovascular embolization device) (13-07), plastic filling material (13-09-01) , registered fillers for plastic surgery (13-09-02), breast implants (13-09-03), tissue engineering scaffold materials (except products that do not contain allogeneic or animal-derived materials) (13-10) , Absorbable surgical anti-adhesion dressings (except products that do not contain animal-derived materials) (14-08-02)

III. Other allogeneic implantable medical devices and implantable medical devices directly obtained from animal tissues.

Besides, in the entrusted production of medical devices, what are the responsibilities of the consignor and trustee?

I. Consignor

i. The trustee shall be provided with the quality management system documents for the entrusted production of medical devices and the product technical requirements that have been registered or filed.

ii.To evaluate the production conditions, technical level and quality management capability of the trustee, and confirm that the trustee has the conditions and capacity of entrusted production.

iii． Providing guidance and supervision of the production process and quality control.

iv. Being responsible for the quality of the medical devices commissioned.

v. The management of the entrusted party’s production practices should be strengthened to ensure that they are carried out in accordance with statutory requirements.

II. Trustee

i.Medical device manufacturing enterprises with corresponding production conditions

ii. The production shall be organized in accordance with the medical device production quality management standards, mandatory standards, product technical requirements and entrusted production contracts.

iii. All entrusted production documents and records shall be archived

iv. The entrusted party shall be responsible for the quality of the entrusted medical devices.

III. Consignor and trustee

A contract for entrusted production shall be signed to clarify the rights, obligations and responsibilities of both parties.

Finally, what are the processes for commissioned production?

I. The trustee shall carry out production in accordance with the relevant standards and keep all entrusted production documents and records.

II. The consignee shall sign the entrusting production contract with the consignor.

III. The commissioned party shall publish the information of the commissioned products in accordance with relevant regulations.

IV. After the entrusted production is completed, the entrusted party shall report to the local relevant departments in a timely manner.

BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

Source：Medical Equipment Learning Exchange

Translated & edited by info@bradyknowsmedical.com