¿Qué trámites locales permiten una aprobación rápida de transferencias en China?
Guidance of order 104 in 2020
In order to further implement the State Council's "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices" and the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices" issued by the General Office of the CPC Central Committee and the General Office of the State Council, implement the "delegation, regulation and service" reform and optimize the business environment requirements, comprehensively deepen the reform of the medical device review and approval system, promote the high-quality development of the medical device industry, and better meet the public health needs, the following matters are hereby announced regarding the production of products with imported medical device registration certificates by enterprises in China:
I. Scope of Application
This announcement applies to matters related to the production of Class II and Class III products with imported medical device registration certificates by foreign-invested enterprises established in China by registrants of imported medical devices.
II. Registration Requirements
(I) Foreign-invested enterprises established in China by registrants of imported medical devices shall, as registration applicants, submit domestic medical device registration applications to the drug supervision and administration department. In principle, the content of the registration application, except for the name, residence and production address of the registrant, shall be consistent with the relevant matters stated in the corresponding imported medical device registration certificate and its attachments.
(II) El solicitante deberá presentar los materiales de solicitud de registro de conformidad con los requisitos del Anuncio sobre los Requisitos para los Materiales de Solicitud de Registro y el Formato de los Documentos de Aprobación para Dispositivos Médicos (Anuncio N.° 43 de 2014 de la Administración Estatal de Alimentos y Medicamentos) y el Anuncio sobre los Requisitos para los Materiales de Solicitud de Registro y el Formato de los Documentos de Aprobación para Reactivos de Diagnóstico In Vitro (Anuncio N.° 44 de 2014 de la Administración Estatal de Alimentos y Medicamentos).
Entre ellos, se pueden presentar la información resumida, la información de investigación, la evaluación clínica, el archivo de riesgo del producto de 1. dispositivo médico; materias primas (cuando corresponda), procesos de producción (cuando corresponda), evaluación del desempeño analítico, determinación del valor de juicio positivo o intervalo de referencia, validación de estabilidad, evaluación clínica, archivo de análisis de riesgo de 2. productos reactivos de diagnóstico in vitro, y los materiales de solicitud de registro original de dispositivos médicos importados. Los registrantes de importación y los solicitantes de registro nacionales deben garantizar la relevancia y el respaldo de la información anterior para esta solicitud de registro.
(III) El procedimiento de solicitud de registro se implementará de conformidad con las "Medidas de gestión del registro de dispositivos médicos", las "Medidas de gestión del registro de reactivos de diagnóstico in vitro" y las disposiciones pertinentes sobre la presentación electrónica de dispositivos médicos.
(IV) If the registration application is submitted and approved in accordance with the requirements of this announcement, the medical device registration certificate number of the relevant imported product that has been approved for registration shall be stated in the notes column of the registration certificate.
III. Quality management system verification requirements
The applicant shall ensure that the domestic production includes the main production process of the product, and promise that the main raw materials and production process will not change, and provide a self-inspection report that the product's domestic production quality management system complies with my country's "Medical Device Production Quality Management Standards" and a comparison report on the equivalence of domestic and foreign quality management systems. The drug regulatory authorities shall conduct a comprehensive review of domestic registration applicants in accordance with the medical device registration quality management system verification work procedures, focusing on the equivalence and traceability of domestic and foreign quality management systems, and whether the system changes brought about by the change of the production process will generate new risks and cause changes in registration matters.
IV. Requisitos de supervisión posterior a la comercialización
Domestic registrants shall apply for medical device production licenses in accordance with the "Medical Device Production Supervision and Management Measures", strictly implement the main responsibility for quality and safety, and strengthen the quality management of medical devices throughout their life cycle; in accordance with the requirements of the "Medical Device Production Quality Management Standards", establish and improve the quality management system and ensure its effective operation.
V. Other aspects
For overseas registrants invested by Chinese enterprises that produce Class II and Class III medical devices in China that have obtained imported medical device registration certificates, this announcement shall apply for registration of the product.
For matters related to products that have obtained medical device registration certificates in Hong Kong, Macao and Taiwan, refer to this announcement.
This announcement shall take effect from the date of the announcement.
Annex: technical documentation of fast track (detailed req for payed gap analysis)
- CH1.04 Formulario de solicitud
- CH1.06 Sistema de gestión de la calidad, sistema integral de calidad u otros documentos de certificación
- CH3.3 Requisitos básicos (EP) para la seguridad y la eficacia
- CH6A.3.1 Product description information, CH6A.3.2 General production information (for medical devices) CH6B.6.3 Production and service control information (for in vitro diagnostic reagents)
- CH3.4.1 List of standards (product technical requirements)
- CH3.4.2 Declaration of conformity and/or certification
- CH5.03 Etiqueta/instrucciones de uso, CH5.02 Etiqueta del producto/embalaje (para dispositivos médicos) CH5.3 Instrucciones de embalaje/instrucciones de uso, CH5.2 Etiqueta del producto/embalaje (para reactivos de diagnóstico in vitro)
- CH1.11.7 Declaration of conformity (for medical devices) CH1.11.6 Declaration of conformity (for in vitro diagnostic reagents)
Original resource
Imported medical devices are manufactured by enterprises in China
Adjust and optimize the production of imported medical devices in Chinese enterprises
Mejores prácticas
We have accompanied some manufacturers either to register „fast track“ approval of medical device or establish a production site with Chinese GMP.
Aquí hay algunas lecciones aprendidas:
Entidad jurídica (actualizada en 2025):
Una empresa con inversión extranjera puede ser una empresa establecida por el titular del registro de dispositivos médicos importados, o una empresa con el mismo controlador efectivo que dicho titular. Es decir, la empresa con inversión extranjera establecida por el titular del registro de dispositivos médicos importados, o con el mismo controlador efectivo que este, puede producir productos de segunda y tercera categoría con el certificado de registro de dispositivo médico importado dentro del territorio de la República Popular China.
Producción:
The foreign manufacturer must have own production entity in China. Outsourced production of medical device is not allowed.
Los fabricantes legales de nuevos productos chinos deberían producir dispositivos médicos.
A design transfer bw R&D and Chinese production is complex.
Los requisitos técnicos del producto deben estar representados en la inspección de entrada, en proceso y final del dispositivo médico. En caso contrario, se deberá proporcionar una justificación.
Registration:
El certificado chino anterior debe ser válido en el momento de la presentación del producto.
Among technical documentation submitted to authority, the critical process of production workflow should not be changed.
Type testing of medical device must be repeated in China.
Documentación técnica
Como se indica arriba, solo se necesitan 9 capítulos principales de TD para la presentación.
Do NOT forget that
- El nombre chino del producto puede ser diferente al original.
- PTR/Type testing takes at least one year & CH 3.4.1
- El producto debe cumplir con las normas chinas obligatorias (GB y YY).
Sistema de gestión de la calidad:
A Chinese conform quality management system must be established. Parallel to product registration a Chinese GMP must be certified by authority.
A big challenge is how to transfer local QM system (ISO 13485 or QSR) to Chinese QM and how to have a design transfer from headquarter of manufacturer?
Tactic:
Se busca una persona con experiencia en gestión, con mentalidad china e internacional. Es necesario preparar y obtener simultáneamente la certificación GMP china y el registro del producto. La interfaz entre asuntos regulatorios, I D, gestión de productos y producción debe estar claramente definida en un proyecto de gestión multipartito.
A product variant to approved overseas medical device must be differentiated.
¿Qué podemos apoyar?
Besides the typical product registration and quality management system in production site in China, we can offer a free gap analysis based on your product status.
As the certificate is invalid, the cost of Chinese production is too much or no approved medical device is ever in China. There are always options as outsourced production to have made in china products to benefit from central value-based procurement.
Upon your customer need, we can be interim manager playing all roles in fast track project.
También podríamos ofrecer un taller en el extranjero o en China dedicado a la comunicación intercultural e interdisciplinaria para lograr los mejores indicadores clave de rendimiento (KPI) regulatorios y económicos.
