Hoja de ruta del registro chino
1. Objetivo de aprendizaje
In this session you should know the simplified work flow to register medical device or IVD in China as an overview.
2. Video
3. Hoja de ruta del registro chino
a. Marco regulatorio (autoridad china)
En 2018, la Administración Nacional de Productos Médicos (NMPA, por sus siglas en chino: 国家药品监督管理局) reemplazó a la antigua Administración Nacional de Alimentos y Medicamentos de China (CFDA). Como parte de la Administración Estatal para la Regulación del Mercado (SAMR), la NMPA se encarga de la supervisión de medicamentos, dispositivos médicos y cosméticos en China. Su principal función es elaborar la legislación sobre medicamentos, dispositivos médicos y cosméticos, así como supervisar su implementación. Además, la NMPA también es responsable de las normas, la gestión de la calidad, el registro y las actividades posteriores a la comercialización, incluyendo la inspección de los productos mencionados.
*In-vitro Diagnostics (IVD) belongs also to regim of NMPA
Responsabilidad de la NMPA:
(1) To supervise the safety of drugs (including traditional Chinese medicines (TCMs) and ethno-medicines, the same below), medical devices and cosmetics; to draw up regulatory policy plans, organize the drafting of laws and regulations, formulate normative documents, and supervise the implementation thereof; to research and formulate regulatory and supportive policies that encourage new technologies and new products for drugs, medical devices and cosmetics.
(2) To undertake standards management for drugs, medical devices and cosmetics; to organize the formulation and publication of the Chinese Pharmacopoeia and other drug and medical device standards, organize the drafting of cosmetic standards, organize the formulation of the classification management system, and supervise the implementation thereof; to participate in formulating the National Essential Medicine List, and assist in the implementation of the national essential medicine system.
(3) To regulate the registration of drugs, medical devices and cosmetics; to develop the registration system, conduct strict review and approval for marketing, improve measures to facilitate the review and approval process, and organize the implementation thereof.
(4) Llevar a cabo la gestión de calidad de medicamentos, dispositivos médicos y cosméticos; desarrollar Buenas Prácticas de Laboratorio (BPL) y Buenas Prácticas Clínicas (BPC), y supervisar su implementación; desarrollar Buenas Prácticas de Fabricación (BPF) y supervisar su implementación de acuerdo con las responsabilidades de la NMPA; desarrollar buenas prácticas sobre la distribución y el uso de productos médicos y guiar su implementación.
(5) Realizar la gestión de riesgos posteriores a la comercialización de medicamentos, dispositivos médicos y cosméticos; organizar el seguimiento, la evaluación y el manejo de reacciones adversas a medicamentos, eventos adversos de dispositivos médicos y reacciones adversas a cosméticos; realizar la gestión de respuesta de emergencia para medicamentos, dispositivos médicos y cosméticos de conformidad con la ley.
(6) To undertake management of qualifications for licensed pharmacists; to formulate regulations of qualifications for licensed pharmacists, and guide and supervise the registration of licensed pharmacists.
(7) To organize and guide the supervision and inspection of drugs, medical devices and cosmetics; to develop the inspection system, investigate and punish illegal activities during the registration process for drugs, medical devices and cosmetics in accordance with law, and organize and guide the investigation and punishment of illegal activities during the manufacturing process in line with NMPA's responsibilities.
(8) Participar en el intercambio y la cooperación internacionales en la regulación de medicamentos, dispositivos médicos y cosméticos, y participar en el desarrollo de normas y estándares regulatorios internacionales pertinentes.
(9) To guide the work of drug regulatory departments of all provinces, autonomous regions, and municipalities directly under the Central Government.
(10) Completar otras tareas asignadas por el Comité Central del PCCh y el Consejo de Estado.
Among the centers of NMPA, Chinese medical device evaluation (CMDE) performs technical evaluation of medical device and IVD. Its role is quite similar to Center for Devices and Radiological Health (CDRH) at FDA in USA.
Responsibility of CMDE
(1) Ser responsable de la aceptación y revisión técnica de la solicitud de registro de productos sanitarios nacionales de Clase III y productos sanitarios importados; ser responsable de la presentación de productos sanitarios importados de Clase I.
(2) Participate in the drafting of relevant laws, regulations and normative documents related to the registration administration of medical devices. Organize the formulation and implementation of relevant technical reviews norms and technical guidelines for medical devices.
(3) Undertake the technical review of medical devices involved in emerging medical products such as regenerative medicine and tissue engineering.
(4) Coordinar el trabajo de inspección relacionado con la evaluación de la revisión de dispositivos médicos.
(5) Realizar investigaciones sobre las teorías, tecnologías, tendencias de desarrollo y cuestiones legales relacionadas con la revisión de dispositivos médicos.
(6) Be responsible for providing guidance and technical support for local departments in the technical review of medical devices.
(7) Organizar servicios de consultoría pertinentes e intercambios académicos, y llevar a cabo intercambios y cooperación internacionales (regionales) relacionados con la revisión de dispositivos médicos.
(8) Undertake other tasks assigned by NMPA.
b. Análisis previo a la comercialización
One of the most important prerequisites to register medical device in China is country of origin approval: e.g. Declaration of Conformity (EU)/ Certificate to Foreign Government (US). The exception of this prerequisite is for innovative products or at pilot zone with only one valid overseas approval.
Then you have to find a Chinese agent for foreign manufacturers who submits product dossier to NMPA and acts as a liaison between authority and legal manufacturer.
Desde el principio, el fabricante debe definir si el producto en cuestión es un dispositivo médico en China:
Medical device is an instrument, equipment, appliance, in vitro diagnostic reagent and its calibrator, material, and other similar or relevant articles including necessary computer software, directly or indirectly contacting human body; the effectiveness are obtained mainly through physical means other than pharmacological, immunological or metabolic ways, or such ways are involved in but only play auxiliary roles; which is used to achieve the following intended outcomes:
Diagnóstico, prevención, seguimiento, tratamiento o alivio de enfermedades.
· Diagnosis, monitoring, treatment, alleviation or functional compensation for an injury
· Life support or life sustaining
· Contraception Control
· Examination of the sample from human body to provide information for medical or diagnostic purpose
A continuación, se debe determinar la clasificación del producto en cuestión, lo cual define el alcance de la documentación técnica. Es recomendable realizar un análisis de las deficiencias de la documentación técnica existente en el país de origen en comparación con los requisitos chinos.
c. Inicio de la inscripción
After pre-market strategy, the preparation of complex Chinese technical documentation is starting. Be aware to fix most difficult tasks first. While the local testing takes long, manufacturer should organize the sampling in time and send it to test in a certified Chinese lab. Depending on product code of medical device, Chinese clinical evaluation or clinical study could be very challenging.
The output of preparation is to submit electronic dossier to Chinese authority. Then the clock is ticking on the side of review of CMDE.
d. Product approval and post market
The Chinese registration could take around 2 years for class II and III medical device. The success approval is rewarded as a Chinese certificate. Don’t forget that there are also many post market activities after the product is approved in China
Related link
Base de datos internacional de dispositivos médicos
Semana Negra 2005
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