Q&A of medical device (IVD) in China
1. What is "country of origin" approval?
It is also called home country approval. One of the most important prerequisites of medical device registration in China is country of origin approval. This means, where the legal manufacturer is located, the product certificate issued by the authority there is a MUST for initial and change registration.
You dont need home country certificate to make a nenewal every 5 years in China. Extend your Chinese products life even it is not valid under MDR till 2027/2028.
In EU it refers to EC certificate and Declaration of Conformity and in US to certificate to foreign government.
Another option of country of origin is to get medical device approved at manufacturing site instead of legal manufacturing site outside China.
2. What is electronic regulated product system (eRPS)?
Este sistema es una plataforma para enviar la documentación técnica electrónica a la autoridad competente para el registro de dispositivos médicos en China. Solo la entidad china (por ejemplo, el agente chino) necesita este sistema. Ni el distribuidor chino ni el fabricante extranjero pueden solicitar la cuenta sin la figura del agente chino.
It is similar to eSTAR in US and Canada.
Se aplica a todos los tipos de registro de dispositivos médicos de clase II y III, excepto a los dispositivos médicos de clase I.
As of 1. Nov. 2019 all registration documents have to be submitted through eRPS system, and so forth in new submission format of technical documentation in line with the “ table of contents” of IMDRF.
3. ¿Cómo cambiar de agente chino?
You can change Chinese agent any time in China unless the original product certificate is not available (NMPA certificate and product technical requirement).
Le recomendamos que conserve personalmente la certificación electrónica china y toda la documentación china presentada.
"Change of Chinese agent" belongs to change registration in administration matter. The review time by authority is 10 working days and there is no official cost.
As Chinese agent you have many post market obligations:
Register of UDI, Report of adverse event and recall, Submit annual QM report, register assurance code and report of PSUR.
Contact us to have a neutral transfer to check all critical poins.
4. What can I do if I miss “Chinese medical device certificate”?
NMPA certificate and product technical requirement are extreme important. Like without having passport you can`t enter China. If you even dont have electronic Chinese product certificate, legal manufacturers can apply to reissue a new certificate in lost cause.
In accordance to order 91, 2015 the new certificate will be reissued in 10 working days and there is no official cost. The “lost” certificate will be invalid.
5. ¿Cuándo es apropiada una reunión previa a la presentación?
En China también existe un sistema de reuniones previas al registro del producto para organizar una reunión con el CMDE. Sin embargo, esta oportunidad de obtener opiniones de expertos de la autoridad china solo se presenta una vez al mes, los viernes. Los fabricantes pueden autorizar a sus agentes a solicitar una cita para ese día, ya sea en línea o acudiendo personalmente sin necesidad de registro previo.
For one pre-meeting manufacturers can pose 5 questions. Normally you can get a very brief answer in written form after pre-submission meeting.
Unlike Q-submission in US, you can`t have a professional pre-submission assessment of your tactic and technical documentation.
6. ¿Cuál es el procedimiento de aplicación de la clasificación de productos?
In case, you are uncertain whether you product is medical device in China, or you can`t find matching product code with precise intended use to your product, you can submit an application of classification at national institute of food and drug control (NIFDC).
La documentación habitual a presentar incluye la descripción del producto (uso previsto, información sobre productos similares, etc.), una foto o vídeo del producto, el expediente de gestión de riesgos, los requisitos técnicos del producto, cualquier homologación internacional, el manual de instrucciones (borrador) y demás material técnico de apoyo. El trámite es gratuito y tarda aproximadamente 30 días naturales.
7. Does bundle of product group for registration exist at NMPA?
Yes, in term of one unit including all models and variants, manufacturer can make one product registration if the products in one unit have same intended use, technical characteristics, mechanism of action and materials.
It is recommended to clear the naming rule of the products up at submission dossier by explaining the meaning and difference of the models and variants.
8. ¿Qué son la inspección en el extranjero y la inspección por muestreo en China?
For overseas manufacturers it is sufficient to submit ISO 13485 certificate for product registration. After product approcal NMPA inspects the overseas manufacturers’ facilities rather in a risk-based and random basis than FDA or annual inspection by notified body.
En 2018 se publicó una guía sobre "Inspección en el extranjero de medicamentos y dispositivos médicos" que los fabricantes extranjeros deben cumplir.
Overseas manufacturers can assign any agents to accompany the inspection by NMPA. After receiving the inspection notice the agents must give
basic information of AE and power of attorney in
20d, as well as
site master file and other supportive documents
in
40d. The inspection of medical device includes
general info about legal manufacturer, supplier management, personals, manufacturing site, equipments, document control, production and material storage
.
If the manufacturers get the findings in inspection report, by objection a clarification must be made in 10d. At the end, manufacturers have to provide feedbacks (it could be plans of finding measures) in 50d to authority.
9. Vigilancia posterior a la comercialización
a. ¿Cómo se informa de un evento adverso en China?
As of 01.01.2019 the new requirement about reporting of adverse events in China is into force. Due to guidance “Adverse Events Monitoring and Reassessment of Medical Device” the reporting of AE is strongly strengthened. The Market Authorization Holder applies for legal manufacturer or Chinese agent of overseas manufacturers. User facility and distributor are also involved in monitoring of AE.
Cronograma de registro e informe de AE en China:
| Tipo | Hora de registro | ||
|---|---|---|---|
| Individual | 7d | 30 días | |
| 20 días, 30 días para envíos internacionales (AE) | 45d | ||
| Grupo | Grupo | 12 horas, por cada AE en 24 horas | 7d |
b. ¿Qué es un informe de evaluación de riesgos periódicos (PRER)?
This is a part of requirements under two regulations at question 9a above. NMPA published in 2020 the guidance “period risk evaluation report of medical device”. The name of guidance is confusing. It is actually better to be translated to “summary of adverse events with risk evaluation”. Risk evaluation can be interpreted as analysis of reasons and measurements of AE. It applies to AE of medical device worldwide including in China. The overseas manufacturers have to submit English and Chinese report.
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.
For class I medical device and from first extention registration of class II and III medical device, PRER is just needed to keep internally as records, namely every 5 years.
Period risk evaluation report in China is a abbreviate Periodic Safety Update Report (PSUR).
Use our template to have a fast and professional record of Chinese PSUR.
10. What is approval of medical device in emergency need in Hainan Province?
In 2020 there is a wide spread notification from Chinese authority that some special medical device can undergo rapid approval in Hainan province . In fact it applies only to medical device in emergence need for rare disease and for prevention or treatment of severely life-threatening disease.
El producto médico debe contar con la aprobación original de su país y no deben existir productos similares en China.
Secondly the overseas manufacturer has to find a user facility with “good clinical practice” and to fulfil other conditions as reporting adverse event capabilities.
Ambas partes podrán solicitar entonces a las autoridades de Hainan una evaluación del dispositivo médico en caso de necesidad urgente.
