[Policies and Regulations] Official Q&A (Part 2) : Common Questions Regarding On-site Inspections of Medical Device Production

Medical devices

Inspection of the production site

The Center for Food and Drug Evaluation of the National Medical Products Administration provides irregular answers to questions related to the production inspection of medical device enterprises to help them comply with regulatory requirements.

Question 01: Due to capacity demands, the production area needs to be expanded. The facilities and equipment for the research and development of registration inspection projects and the trial production of products need to be moved to the new production area. The R&D projects in the original production area all comply with regulatory and quality control requirements. During the equipment relocation process, photos of the on-site production equipment in the original production area will be taken, and video files will be left for the relocation process. Is this feasible?

Reply: According to the requirements of the "Guidelines for the Verification of the Quality Management System for Medical Device Registration", the factory facilities and equipment used for the research and development and production of registration inspection products and clinical trial products, as well as the relevant usage records, should be retained. In the event of force majeure that makes it impossible to retain, evidence materials that can prove the authenticity, completeness and traceability of the activities in the product realization process such as research and development, production and verification shall be retained. It is suggested that before dismantling the original production line, active communication be maintained with the local regulatory authorities and technical review institutions, and appropriate measures be taken to handle the matter.

Question 02: The "Guidelines for the Evaluation of Raw Material Changes in Passive Medical Device Products" states that "China has implemented a master document system for medical devices. Regardless of whether the raw material manufacturer has registered the master document or not, the medical device registrant, as the responsible party for the quality of medical device products, should sign a responsibility and obligation agreement with the raw material manufacturer." And conduct a thorough assessment of any changes in raw materials that may have an impact on the final medical device. Our company has signed A quality agreement with component supplier A, stipulating their respective obligations. Is it still necessary to sign an agreement with the raw material manufacturer (raw material supplier B of A)? A signed A quality agreement with B. Can it be considered that signing a quality agreement with supplier A is equivalent to meeting this clause?

   Reply: Medical device manufacturing enterprises should, in accordance with the requirements of the "Good Manufacturing Practice for Medical Devices" and the "Guidelines for Supplier Audit of Medical Device Manufacturing Enterprises", sign quality agreements with major raw material suppliers, clarify the quality responsibilities of both parties, and establish a supplier audit system to audit and evaluate suppliers to ensure that the purchased items meet the quality requirements for their product production. Therefore, enterprises should sign quality agreements with component suppliers and conduct thorough and comprehensive evaluations of them during audits, paying attention to sales agency agreements or quality agreements between suppliers and raw material manufacturers or general agents, so as to ensure that the raw materials purchased from suppliers comply with laws and regulations and the requirements of the enterprise itself.

Question 03: Our company is going to develop a new product. Can a certain model and specification of the product in the technical requirements be entrusted to another company for production in the form of a registrant system, while the rest of the models will be produced by our company itself?

Reply: According to the requirements stipulated in the "Regulations on the Supervision and Administration of Medical Devices", medical device registrants and filers may produce medical devices by themselves or entrust enterprises that meet the provisions of these regulations and have the corresponding conditions to produce medical devices. Those engaged in the production of medical devices shall meet the requirements of Article 30 of the Regulations on the Supervision and Administration of Medical Devices. As mentioned in the title, if an enterprise only entrusts the production of a certain model of product, the medical device registrant shall sign an entrustment agreement with the entrusted production enterprise based on the actual entrustment situation, clearly defining the rights, obligations and responsibilities of both parties. The entrusted manufacturing enterprise shall organize production in accordance with laws and regulations, good manufacturing practice for medical devices, mandatory standards, product technical requirements and the entrustment agreement, be responsible for production activities, and accept the supervision of the entrusting party. The entrusting party and the entrusted party shall establish an effectively connected quality management system for medical device production to ensure compliance with the requirements of relevant laws and regulations.

Source: Website of the Center for Food and Drug Control, National Medical Products Administration