Encyclopedia of medical device and IVD in China
Official Definition
National Medical Products Administration (NMPA)
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.
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.
El Reglamento sobre la supervisión y administración de dispositivos médicos (Orden del Consejo de Estado n.º 739) tiene la misma validez jurídica que el Reglamento (UE) 2017/745 (Reglamento sobre Dispositivos Médicos, MDR) o la Ley Federal de Alimentos, Medicamentos y Cosméticos (FD&C Act) en Estados Unidos. Es la máxima normativa aplicable a los dispositivos médicos y a los productos sanitarios para diagnóstico in vitro (IVD).
Dispositivo médico
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
Medical device users refer to institutions that use medical devices to provide medical and other technical services to others, including medical institutions, family planning technical service institutions, blood stations, apheresis plasma stations, and rehabilitation assistive device adaptation institutions.
Large-scale medical device refers to large-scale medical device with complex technology, large capital investment, high operating cost, large impact on medical expenses and included in catalog management.
Registrante (solicitante) y titular del registro (presentador) del dispositivo médico
Depending on translation turning up in many regulations, it means legal manufacturer for class II and III as registrant or applicant, for class I as record holder or filer.
1. Inscripción
agente chino
También se le denomina representante autorizado o representante local. Equivale a un agente en EE. UU. o a una persona responsable en el Reino Unido. Se trata del representante local en China que presenta el expediente, registra el UDI, informa sobre eventos adversos y se comunica con las autoridades chinas.
Especificación de rendimiento según los requisitos técnicos del producto.
Indicadores funcionales y de seguridad del producto terminado que pueden verificarse objetivamente. No se recomienda especificar el contenido de la investigación y evaluación en la especificación de rendimiento de los requisitos técnicos.
Electronic regulated product system (eRPS)
This system is a platform to submit the electronic technical documentation to authority in term of medical device registration in China.
2. Post market
evento adverso grave
The following is part of adverse event form what manufacturer has to fill.
Serious adverse event is defined as the damage that one of the following situations is met:
1. Pone en peligro la vida.
2. Causing permanent harms to body function or injuries to body structure
3. Medical measures are required to avoid the above-mentioned permanent harms and injuries
Group adverse event of medical device refers to the events occurred by the same medical device during its use that causes harm or threat for the health or life safety of a certain amount of population within a relatively concentrated time and area.
La monitorización de los eventos adversos relacionados con los dispositivos médicos se refiere al proceso de recopilación, notificación, investigación, análisis, evaluación y control de los eventos adversos relacionados con los dispositivos médicos.
Recall
First-Level recall: the use of the medical device may or has caused serious health hazards.
Second-level recall: the use of the medical device may or has caused temporary or reversible health hazards.
Tertiary-level recall: The possibility of using the medical device to cause harm is small, but it still needs to be recalled.
3. Producción
Control de calidad
Verification/confirmation/monitoring/measurement/inspection/testing activities and their quality management related to the
main raw materials, parts, outsourced parts, intermediate products, finished products, primary packaging materials, labels, etc. related to the product and to the
production process, especially the key processes and special processes in the production process.
Hecho
Hospital
There are different levels of hospitals in China.
- Un hospital de atención primaria suele ser un hospital municipal con menos de 100 camas. Su función es proporcionar atención preventiva, atención médica básica y servicios de rehabilitación; es decir, atención primaria. Un hospital de atención primaria es similar a los hospitales comunitarios del oeste de Estados Unidos.
- Un hospital secundario suele estar afiliado a una ciudad, condado o distrito de tamaño mediano y cuenta con más de 100 camas, pero menos de 500. Su función es proporcionar servicios de salud integrales, así como impartir formación médica e investigar a nivel regional. Un hospital secundario es similar a un hospital regional o distrital en Occidente.
- Un hospital terciario es un hospital general de referencia integral a nivel municipal, provincial o nacional, con una capacidad superior a 500 camas. Se encarga de proporcionar servicios de salud especializados, desempeña un papel fundamental en la formación médica y la investigación científica, y funciona como centro médico que brinda atención a múltiples regiones. El hospital terciario es similar a un hospital de referencia terciario en Occidente.
Further, based on the level of service provision, size, medical technology, medical equipment, and management and medical quality, these 3 grades are further subdivided into 3 subsidiary levels: A, B and C (甲, 乙, 丙). This results in a total of 9 levels.
Official database
UDI
Evento adverso y retirada del mercado
From our best practise
Modificar el registro
If significant change of product happens, you have to start a new registration. In US is called new 510k. In China it is called change registration or re-registration. It hides automatically that you will provide evidence and describe main significant change at dossier. The original registration will be replaced by change registration.
Change on administrative matter is a category for following:
· name or address of overseas manufacturer
· Nombre o dirección del agente chino
is unique Chinese, it is also called in-country testing or product/sample testing. The device must be sent to a Chinese lab, according to Chinese standards specifications are tested. For active electrical medical device is typically safety - and electromagnetic compatibility.
Informe anual de autoevaluación
For foreign manufacturers, Chinese agent is responsible to submit this annual report every year before April. Besides the basic info of approved medical device, following chapters are needed:
· Non-conforming devices
· Todo tipo de inspecciones nacionales
· Adquisiciones centrales
· Penalties
· Auditoría interna
Easy example
Product code is 6 digits code from classification catalog. There are 22 main product categories. Depending on intended use, medical device can be categorized into precise 6 digits product code and belonging classification.
product code 21-01-01, Radiotherapy planning software, class III.
certificado chino
After approval by authority, legal manufacturer receives a Chinese certificate, now electronically. It is 5 years valid. Attached on certificate is product technical requirement.
Número de certificación
Emitido por la autoridad china tras su aprobación.
Class II and III medical device
Certificado Nacional de Registro de Dispositivos Médicos 20162540407
1: año de aprobación (en este caso 2016)
2 : product class (in this case 2)
3: parte del código del producto
4: número de serie de registro en NMPA
Dispositivos médicos de clase I
Número de registro nacional de equipos médicos: 20160407
Medical issurance consumable code
El código de consumibles del seguro médico se divide en 5 partes, con un total de 20 códigos.
1 code: consumable code, C
Código 2-7: código de clasificación de 6 dígitos
8-10 code: common name code
11-15 code: product feature code
16-20 code: Production enterprise code
Product technical requirement (PTR)
is a document submitted to testing institutes (or Chinese labs) by legal manufacturers. It is a characteristic part of medical device indicating all key performance specifications and testing methods derived from Chinese standards whereby the testing institutes check own testing capability and conduct type testing.
Period risk evaluation report (PERE)
Es similar al PSUR europeo. Para los dispositivos médicos de clase II y III, el PRER debe presentarse electrónicamente cada año después de la fecha de aprobación inicial hasta el primer registro de prórroga.
ver plantilla
Etiquetado chino
For and after registration you need Chinese labelling, as instruction for use and label. In China it is regulated in guidance and standard which is essential on instruction for use and label as registration number, term of symbol etc.
see following example
evento adverso grave
The following is part of adverse event form what manufacturer has to fill.
Serious adverse event is defined as the damage that one of the following situations is met:
1. Life threatening;
2. Causing permanent harms to body function or injuries to body structure;
3. Medical measures are required to avoid the above-mentioned permanent harms and injuries.
Aprendizaje electrónico de dispositivos médicos
Try to benifit from our template, elearning (expanding, see one short example below in youtbe.), blog. We try to generate regulatory affairs science to explain not only Chinese regulation in global language.
Another option to be up to date with Chinese regulation and be efficient at Chinese registration is to book our personal training based on your demand, either alone or in group. Bring your questions, case studies, we teach the highlights of registration, project, and communicstion skills and give suggestions for your questions.
