Q&A about imported medical device in China
Registro
1. Whether overseas animal-derived derivatives are possible for the production of implantable medical devices
8 de mayo de 2023
P: En el Capítulo 6.9.2 de las "Directrices para la inspección in situ de dispositivos médicos implantables en las Buenas Prácticas de Fabricación de Dispositivos Médicos" se indica claramente que deben conservarse los documentos de certificación o confirmación de los centros de cría de animales (se prohíbe la importación de animales), de la alimentación (se prohíbe la importación de piensos, se prohíbe la alimentación con proteínas animales), etc. ¿Puedo preguntar: ① Se pueden utilizar derivados de origen animal importados, como la gelatina (derivada de la piel de cerdo y producida en Estados Unidos) o el colágeno (derivado de los tendones de Aquiles bovinos y producido en Australia o Nueva Zelanda), para producir dispositivos médicos implantables? ② Si los dispositivos médicos implantables producidos son solo para exportación, ¿se pueden utilizar?
A: Regarding question ①, it is recommended to consult the corresponding medical device technical review unit. In terms of the system, the company should retain the necessary documents and materials in accordance with GMP requirements to fully prove that the product is safe and reliable. Regarding question 2, according to Article 59 of the "Medical Device Supervision and Administration Regulations": "Companies that export medical devices shall ensure that the medical devices they export meet the requirements of the importing country (region)."
2. Para el registro de productos importados, ¿se puede presentar el registro del producto antes de la verificación/validación de rendimiento (PQ) de la fábrica?
2024-01-09
Q: For imported sterile or implantable medical devices, does the registrant need to complete PQ (Performance Verification/ Validation) before submitting its registration application? Or can the registration submission be submitted after the registrant completes the production of type testing samples/clinical trial samples for registration (completed under a controlled production management quality system)? According to the Medical Device Registration Quality Management System Verification Guidelines (2022 No. 50), will the QM-inspection after product submission include the PQ (Performance Verification/Qualification) part?
A: La verificación/validación del rendimiento del producto debe completarse antes de su envío. La inspección de control de calidad incluye la inspección de la parte del trabajo de verificación/validación del rendimiento del producto.
3. For imported products, if the scope of application of the whole product system and the corresponding accessories approved by the country of origin are inconsistent
Q: when declaring as a whole system, can the scope of application of the whole product system and the accessories be combined as the scope of application for application in China?
A: El ámbito de aplicación del sistema completo del producto y sus accesorios puede informarse de forma conjunta, y para la regulación se puede consultar el ámbito de aplicación de productos similares aprobados en China. El ámbito de aplicación informado no debe exceder el aprobado por el país de origen.
sistema de gestión de calidad
1. Disposiciones aplicables para la verificación del sistema de gestión de calidad para productos de transferencia local.
12/03/2024
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: Debe implementarse de acuerdo con los requisitos del "Anuncio de la Administración Estatal de Alimentos y Medicamentos sobre Asuntos Relacionados con la Producción de Productos de Dispositivos Médicos Importados por Empresas en China" (2020 No. 104). Todo el sistema de gestión de calidad de producción debe cumplir con los requisitos de las regulaciones chinas y los documentos relacionados. Para el trabajo relacionado con el diseño y desarrollo que haya completado en el extranjero, puede utilizarse como información relevante para el diseño y desarrollo, ya que al mismo tiempo, se deben considerar las leyes y regulaciones chinas, las normas nacionales, las normas de la industria, los requisitos de la documentación pertinente, etc., y la nueva dirección de producción, los edificios de la fábrica, las instalaciones, etc. La situación del equipo, el personal, etc., también es diferente a la situación del diseño, desarrollo o producción en el extranjero. Por lo tanto, se recomienda que los solicitantes de registro nacionales completen el trabajo de diseño y desarrollo basándose en su propia situación real y las características de los productos registrados y solicitados, en lugar de simplemente hacer una transferencia de diseño.
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
21/06/2021
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: Su empresa debe establecer un sistema de gestión de calidad compatible con los productos que fabrica y garantizar su funcionamiento eficaz de acuerdo con los requisitos de la normativa de gestión de calidad de la producción. Para asuntos específicos relacionados con el registro, consulte con el centro de evaluación de dispositivos médicos y las oficinas provinciales correspondientes.
4. Overseas factory inspection of medical devices
15/05/2019
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. Para registrar la transferencia al software médico local, ¿necesito construir un servidor independiente?
5 de febrero de 2024
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.
