About Chinese authority NMPA, Chinese regulation and Chinese market of medical device (IVD)
Tags:
Chinese authority, NMPA, medical device,
In vitro diagnostic reagent (IVD),
CMDE, legislative of medical device,
medical device act, Product-specific guidance, Chinese standards (GB, GB/T, YY and YY/T),
GB 9706.1-2020,
YY 9706.102-2021,
definition of medical device, Marketing authorization holder (=registrant=legal manufacturers), NMPA trend, adverse event reporting
1. Chinese Authority of Medical Device and IVD
In 2018 National Medical Products Administration (NMPA, Chinese:国家药品监督管理局) replaced former China food and drug administration (CFDA). As one part of State Administration for Market Regulation (SAMR) the NMPA is in charge of supervision of drug, medical device and cosmetics in China. The core task of NMPA is to draft legislative of drug, medical device and cosmetics and to supervise the implementation of the regulations. Besides it, NMPA is also responsible of standards, quality management, registration and post market activities including inspection of abovementioned products.
*La regulación de los diagnósticos in vitro también pertenece al régimen de la NMPA.
Responsabilidad de la NMPA
(1) Supervisar la seguridad de los medicamentos (incluidas las medicinas tradicionales chinas (MTC) y las etnomedicinas, lo mismo a continuación), los dispositivos médicos y los cosméticos; elaborar planes de política regulatoria, organizar la redacción de leyes y reglamentos, formular documentos normativos y supervisar su aplicación; investigar y formular políticas regulatorias y de apoyo que fomenten nuevas tecnologías y nuevos productos para medicamentos, dispositivos médicos y cosméticos.
(2) Llevar a cabo la gestión de normas para medicamentos, dispositivos médicos y cosméticos; organizar la formulación y publicación de la Farmacopea China y otras normas para medicamentos y dispositivos médicos, organizar la redacción de normas para cosméticos, organizar la formulación del sistema de gestión de clasificación y supervisar su implementación; participar en la formulación de la Lista Nacional de Medicamentos Esenciales y ayudar en la implementación del sistema nacional de medicamentos esenciales.
(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) To undertake quality management for drugs, medical devices and cosmetics; to develop Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), and supervise the implementation thereof; to develop Good Manufacturing Practices (GMP) and supervise the implementation thereof in line with NMPA's responsibilities; to develop good practices on the distribution and use of medical products and guide the implementation thereof.
(5) To undertake post-market risk management for drugs, medical devices and cosmetics; to organize the monitoring, evaluation, and handling of adverse drug reactions, medical device adverse events, and cosmetic adverse reactions; to undertake emergency response management for drugs, medical devices and cosmetics in accordance with law.
(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) Organizar y guiar la supervisión e inspección de medicamentos, dispositivos médicos y cosméticos; desarrollar el sistema de inspección, investigar y sancionar las actividades ilegales durante el proceso de registro de medicamentos, dispositivos médicos y cosméticos de conformidad con la ley, y organizar y guiar la investigación y sanción de las actividades ilegales durante el proceso de fabricación de acuerdo con las responsabilidades de la NMPA.
(8) To engage in international exchange and cooperation in the regulation of drugs, medical devices and cosmetics, and participate in developing relevant international regulatory rules and standards.
(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 centers of NMPA, Chinese medical device evaluation (CMDE) performs technical evaluation of medical device. Its role is quite similar to Center for Devices and Radiological Health (CDRH) at FDA in USA.
Responsibility of CMDE
(1) Be responsible for the acceptance and technical review of registration application of domestic Class III medical device products and imported medical device products; be responsible for the filing of imported Class I medical device products.
(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) Coordinate the inspection work related to the evaluation of medical devices review.
(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.
CMDE is quasi the contacting authority during the approval process with whom the overseas manufacturers communicate. CMDE initials also product-specific guidance und participates in inspections.
Reglamento inglés
There is only one registration workflow at CMDE website and a brief English website of NMPA.
2. Chinese Regulations of Medical Device and IVD
The legislative of medical device is developing in rapid tempo in China. The Regulations on Supervisory Management of Medical Devices have been revised and approved at the the 119th Executive Meeting of the State Council end of 2020 and is valid on 01.06.2021. Since then diverse provisions, notifications and technical guidances are published which should be comply with and followed in the whole life cycle of medical device marked in China.
¿Cómo se desarrolla la legislación sobre dispositivos médicos en China?
Nivel I: Derecho
“Regulations on supervision and administration of Medical Device” (State Council Order No. 739) has the similar legally role as 2017/745 (Medical Device Regulation, MDR) in EU or FD&C Act in US. State Council Order No. 739 is extremely compactly summarized (20k Chinese characters and 107 articles in No. 739 compared to 100k English words and 123 articles in EU MDR) and has only 8 chapters containing registration, manufacturing, after approval sales, adverse event and recall, after approval supervision as inspections and legal liability of medical device.
New
La ley de dispositivos médicos reemplazará la Orden del Consejo de Estado No. 739, que en primer lugar tiene carácter legal...
II. Level: Regulation, NMPA Order
There are many supportive general orders (or provisions) clarifing requirements of product registration, instruction for use, product classification, adverse event and overseas inspection of medical device.
Medical Device Registration and Filing Management Measures (order 47, 2021)
Medidas de gestión del registro y la presentación de documentos de diagnóstico in vitro (Orden 48, 2021)
Guía para la gestión de la calidad en la producción de dispositivos médicos (Orden n.º 107, 2025), Buenas Prácticas de Fabricación (BPF) chinas
Medidas de supervisión y administración de la producción de dispositivos médicos (orden 53, 2022)
Guía para la inspección del sistema de gestión de calidad para el registro de dispositivos médicos (Orden 50, 2022)
Instruction for use and labels of Medical Device (Order 6, 2014)
Monitorización de eventos adversos y reevaluación de dispositivos médicos (Orden 1, 2018)
Guidance for compiling annual self-examination report of medical device quality management system (order 13, 2022)
Overseas inspection of Drug and Medical Device (Order 101, 2018)
III. Nivel: Notificación, orientación general
En realidad, estas directrices emitidas por CMDE suelen ser una guía útil para el registro de productos.
Clinical evaluation of Medical Device (Order 73, 2021)
Evaluación clínica de dispositivos de diagnóstico in vitro (Orden 74, 2021)
Approval of overseas clinical trial data of medical device (Order 13, 2018)
Approval of overseas clinical trial data of In vitro diagnostic reagent (Order 95, 2021)
Technical review of medical software (Order 9, 2022)
Technical review of cybersecurity safety of Medical Device (Order 7, 2022)
Product technical requirement (PTR) of Medical Device (Order 9, 2014)
IV. Nivel: Notificación, guía específica del producto
To discriminate to general guidance, there are product-specific guidance matching most product code.
Si dispone de los cuatro primeros dígitos del código del producto o del grupo general de productos de interés, puede buscar la guía y las normas específicas del producto correspondiente.
3. Chinese Standards of Medical Device and IVD
national (GB) - and industrial (YY) standards
There are two kinds of Chinese standards:
national (GB) issued by the Standardization Administration of China (SAC), and
industrial (YY)
issued by NMPA. The
non-binding or recommended character has prefix /T. Without /T it means
obligatory. In general the version of Chinese standards is at developing stage. Most Chinese standards match the oldversion or edition of harmonised international standards. There are three categories compared to international
standards: identical (IDT), equivalent (EQV), or non-equivalent (NEQ).
Example
NUEVA NORMA GB 9706.1-2020 (válida a partir de mayo de 2026, sustituye a la norma GB 9706.1-2007)
De conformidad con la norma IEC 60601-1:2012, edición 3, Equipos electromédicos—Parte 1: Requisitos generales de seguridad
NEW YY 9706.102-2021 (valid as of May, 2026, replacing YY 0505-2012)
Corresponding to IEC 60601-1-2:2007, edition 3, Medical electrical equipment－Part 1-2: General requirements for safety－Collateral standards: Electromagnetic compatibility－Requirements and tests
Nueva norma GB/T 16886.1-2022 (válida a partir de mayo de 2023)
Corresponding to ISO 10993-01: 2018, Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
YY/T 0316-2016
De conformidad con la norma ISO 14971:2007, Aplicación de la gestión de riesgos a los dispositivos médicos.
GB/T 25000.51-2016 Systems and software engineering―Systems and software Quality Requirements and Evaluation (SQuaRE)―Part 51:Requirements for quality of Ready to Use Software Product(RUSP) and instructions for testing
Every year NMPA makes a plan of revision or new medical device industrial standards. This means that the applied products must be compliant with new standards in all three
types of product registration (initial -, change - and extension registration).
If new obligatory national or industrial standard applies to medical device, very often at least a delta of type testing must be undertaken to fulfill the new requirements. It is similar to an international revision of medical electrical standards as IEC 60601 series for every manufacturers.
Likewise the GB 9706.1-2020 will be prolongated in 2026. As of May, 2026 all medical electrical equipments have to fulfil the new safety requirements at testing and then to be able placed in market. Finally one of the important Chinese standards reaches the international stand of the art.
4. Definition of Medical device in China
Definition
Regulations on the Supervision and Administration of Medical Device (State council order 2021/739)
Artículo 103
Un dispositivo médico es un instrumento, equipo, aparato, reactivo de diagnóstico in vitro y su calibrador, material y otros artículos similares o relevantes, incluido el software informático necesario, que entran en contacto directo o indirecto con el cuerpo humano; su eficacia se obtiene principalmente por medios físicos distintos de los farmacológicos, inmunológicos o metabólicos, o bien dichos medios intervienen pero solo desempeñan funciones auxiliares; y se utiliza para lograr los siguientes resultados previstos:
- Diagnóstico, prevención, seguimiento, tratamiento o alivio de enfermedades
- Diagnóstico, seguimiento, tratamiento, alivio o compensación funcional de una lesión.
- Examen, sustitución, regulación o soporte de la estructura fisiológica o del proceso fisiológico.
- Soporte vital o mantenimiento de la vida
- Contraception Control
- Examination of the sample from human body to provide information for medical or diagnostic purpose
Medical device registrant and record holder
Article 34
can produce medical devices on their own, or they can entrust enterprises that meet the requirements of these regulations and have corresponding conditions to produce medical devices.
Artículo 103
refer to the enterprise or research institution that has obtained the medical device registration certificate or handled the record of medical device.
Medical device registrant and record holder refer to marketing authorization holder (MAH) of class I, II and II medical device. It is the same as legal manufacturer which means that MAH has full power of attorney for medical device.
5. Trend of registration at NMPA (2022)
Nuevos productos registrados
Initial registration are 2500 (+46.2% compared to 2021), change registrations 4224 (+58.5% compared to 2021) and renewals 5281 (-24.8% compared to 2021)
Los dispositivos médicos nacionales de clase III aprobados son el 5425 y el IVD 1287.
Los dispositivos médicos importados de clase III aprobados son el 2377 y el IVD 302.
Approved domestic class II medical devices are 1590 and IVD 877.
¡El dispositivo médico nacional de clase II aprobado es el 32889!
Top 5 foreign countries and top product categories
Los 5 principales países extranjeros son EE. UU. (226+), Alemania (117-), Japón (69-), Corea (42+) y Francia (26, nuevo), que representan el 76,4% del total de dispositivos médicos y productos de diagnóstico in vitro importados.
Top 5 product categories (total 22 product categories) of domestic medical device:
13 Dispositivos implantables pasivos (400, +68,4%)
03 Dispositivos quirúrgicos neurológicos y cardiovasculares (246, +92,2%)
14 Injection, Nursing and Protection Devices (168, +6.3%)
06 Medical Imaging Devices (162, +78%)
01 Active Surgical Devices (113, +76.6%)
Top 5 product groups (total 22 product categories) of imported medical device:
06 Medical Imaging Devices (75, +7%)
13 Passive Implantable Devices (53, +10.4%)
14 Injection, Nursing and Protection Devices (50, new)
17 instrumentos dentales (45, +9,7%)
03 Dispositivos quirúrgicos neurológicos y cardiovasculares (43, +19,4%)
The increase of registrations above is compared to 2021. The reduction of imported medical device is distinct.
En los 5 principales grupos de productos según el número de registros, no destaca el predominio de los productos importados.
Entre los principales grupos de productos comunes, 13 dispositivos implantables pasivos, 3 dispositivos quirúrgicos neurológicos y cardiovasculares, 14 dispositivos de inyección, enfermería y protección y 6 dispositivos de imágenes médicas han cambiado el dominio nacional.
¿Qué podemos apoyar?
The regulation of medical device in China is foundation of not only registration of product but also from product design stage.
Besides receiving newsletter (form), you can book a customer tailored regulation monitoring of wished product types and market trend.
¿Necesita una norma china con análisis conforme a una norma internacional? Contáctenos; también ofrecemos todas las normas chinas traducidas al inglés.
¿Sabía usted que uno de los hallazgos de las inspecciones en el extranjero es la falta de cualificación de la persona responsable según la normativa china?
Manufacturer should have a match of Chinese regulation with corresponding manager and employees. Even at job description it must state the exact Chinese regulation.
Either you are startups, SME of global player, we can offer any kinds of trainings dedicated to medical device.
Contáctanos para una consulta gratuita y analizaremos tus necesidades; ofrecemos talleres especializados tanto presenciales como a distancia.
