Q&A about imported medical device 

Quality management system

1. Applicable provisions for verification of the quality management system for local to transfer products

2024-03-12

Q: Our company is engaged in the conversion of mature IVD products from overseas to domestic production. Since the product has been developed, technology transfer will be done directly. For domestic registrants, does our company’s quality system only need to include design and development transfer, without the need for design, development planning input , output, verify content, etc.?

A: It should be implemented in accordance with the requirements of the "State Food and Drug Administration's Announcement on Matters Related to the Production of Imported Medical Device Products by Enterprises in China" (2020 No. 104). The entire production quality management system should meet the requirements of Chinese regulations and related documents. For the design and development related work you have completed abroad, it can be used as relevant information for design and development input, because at the same time, China's laws and regulations, national standards, industry standards, relevant document requirements, etc. must be considered, and the new production address, factory buildings, facilities, etc. The situation of equipment, personnel, etc. is also different from the situation of foreign design, development or production. Therefore, it is recommended that domestic registration applicants complete the design and development work based on their own actual situation and the characteristics of the registered and applied products, rather than just doing design transfer.

2. Is it feasible for the final packaging process of imported products carried out in China?

2023-04-11

Q: Our company imports medical device and wants to complete key processes including sterilization, inner packaging (sealing) and corresponding quality inspection work abroad. Then after importing into China, the last outermost packaging work is completed and then sold. Is this possible?

A: The registrant should ensure that the imported medical device is a product consistent with the registration or filing declaration information and meets the relevant requirements of Chapter 2 and Article 57 of the "Regulations on the Supervision and Administration of Medical Devices".

3. Production of imported medical device by enterprises in China

2021-06-21

Q: There is an imported Class 3 sterile consumable product (which has obtained an registration certificate) that is planned to be produced in a domestic factory in accordance with the "Announcement of the State Food and Drug Administration on Matters Related to the Production of Imported Medical Devices in China" No. 104 of 2020 to obtain a domestic registration certificate. According to the provisions of Chapter 3 "System Verification Requirements" of Announcement No. 104 of 2020, "Registration applicants shall ensure that domestic production includes the main production process of the product", the production process of the domestic factory is planned to be through the purchase of semi-finished raw materials from the overseas head office, and after acceptance, assembly → cleaning → sealing → sterilization → labeling and packaging → storage after inspection. Can the above production process arrangement meet the requirements of Announcement No. 104 of 2020? Or must the newly established factory in the country establish a production process that is completely consistent with the existing production process of the product of the overseas head office (including the processing process of semi-finished raw materials before the assembly process) to meet the requirements of Announcement No. 104 of 2020?

A: Your company should establish a quality management system that is compatible with the products it produces and ensure its effective operation in accordance with the requirements of the production quality management regulations. For specific registration-related matters, please consult the relevant medical device evaluation center and relevant provincial bureaus.

4. Overseas factory inspection of medical devices

2019-05-15

Q: regarding overseas factory inspections of medical devices, are there clear requirements for the identification of Chinese regulations? Should all applicable regulations be reflected in system documents? If the ISO standard GB or YY system document is directly converted and the ISO standard number is mentioned, is it necessary to add the GB or YY standard number?

A: the purpose of overseas medical device manufacturers to identify Chinese regulations is that "products imported into China comply with Chinese regulations and relevant standards." The specific identification methods and forms are left to the companies themselves.

Software

1.      To register transfer to local medical software, do I need to build an independent server?

2024-02-05

A: Our company is a Sino-German joint venture and plans to carry out work related to the localization of imported software. This software that needs to be localized is independent software and the delivery method is network delivery. The software to be released is uploaded to the server, and the customer purchases it and downloads it from the server for installation and deployment. Based on this, the following two questions need to be consulted: 1. Should the server used for software release be built separately, or can it be mixed with the company's current servers? 2. Before the software is officially released to the server, it will undergo final inspection and release based on technical requirements. But after the release is completed, how should the subsequent sales orders be processed in the delivery process? (Does it still need to reflect release or release after inspection?) 3. Imported independent software is localized, and all design and development documents are in the hands of the German side. The Chinese side uploads the software developed by the German side to the server. So how do the software development environment, testing environment and source code need to be reflected by the Food and Drug Administration during on-site inspections? 4. For network-delivered software, the research and development process is done abroad, so how should the production process in China be reflected? How should the process flow diagram be reflected?

A: Software products also need product release before they can enter the sales stage. During the on-site registration verification, inspectors need to review the design and development documents, and the companies preparing for the inspection should prepare relevant materials in advance. Please write a process flow chart based on the actual process of the software product to be registered, and the R&D and production processes should not be confused. For other matters related to the registration review, it is recommended to consult the technical review agency

Import

1. Q: How to determine whether it is a registered medical device?

A: According to the relevant regulations of the national food and drug administration department, medical devices approved for registration refer to medical devices that are consistent with the content of the medical device registration certificate and attachments and are produced within the validity period of the medical device registration certificate. If the relevant medical device is consistent with the corresponding medical device registration certificate and attachments and is produced within the validity period of the medical device registration certificate, it is not an unregistered medical device; if it is inconsistent, it is not an approved registered medical device.

2. Q: Our company plans to import medical devices for scientific research and testing. Do I need to provide a medical device registration certificate?

A: According to the relevant regulations of the national drug regulatory department, products used for scientific research and testing but not for human diagnosis and treatment do not need to go through relevant registration and filing procedures, and imports do not require relevant certificates from the drug regulatory department. Your company must declare truthfully. The customs will strictly check the true use of imported medical devices declared for scientific research and testing but not for human diagnosis and treatment. If it is found that they are used for human diagnosis and treatment in violation of regulations, the customs will order them to be ordered to comply with relevant laws and regulations. Enterprise returns or destroys.

3. Q:The product parts and components in the "Product Structure and Composition Attachment" of our company's imported medical device registration certificate do not indicate specific specifications and model information. Are the relevant imported medical device parts and components covered by the registration certificate?

A: According to the relevant regulations of the National Drug Administration, if the medical device registration certificate and its attachments do not indicate the specific specifications and models of the parts, then the medical device registration certificate and its attachments do not limit the specific specifications and models of the parts. Parts that meet the information registered in the medical device registration certificate and its attachments can be covered by the medical device registration certificate.