Agente chino
= Marketing authorised holder (MAH), legal representative
A key Factor for Success of Chinese Commercialization of Medical Device
Agente chino para fabricantes extranjeros legales (dispositivos médicos importados o productos de diagnóstico in vitro).
Chinese Agent is also called
authorized - or in country representative. It is equivalent to
US agent or
UK responsible person. The Chinese agent with business license in China is required for
every
overseas manufacturer
who has no entity in China. One manufacturer can assign as many Chinese agents as needed. However, only one Chinese agent per product is allowed. Chinese agent will be written on
NMPA certificate besides the name of legal manufacturer.
Please don´t be too overwhelmed after successful product approval. It is hundred percent your right to request all final
approval certificates (also "product technical requirement" as annex and type testing report) issued by authority. It facilitates the next
change - and extension registration as essential documents.
Tasks of Chinese agent
La responsabilidad regulatoria y los requisitos del agente chino están aumentando.
Responsabilidad del agente chino:
• Compilation of the submission dossiers
• Communication with NMPA
• Report of adverse event
• Assistance of the potential inspection by authority
•
Transfer of regulatory update
New
· Upload of UDI-DI and insurance code in Chinese data base
Es agradable tenerlo
· Prove of IFU and label
Responsabilidad controvertida de la notificación de eventos adversos (licitación) para fabricantes extranjeros
Se plantea un dilema sobre quién debe coordinar activamente los eventos adversos en las actividades posteriores a la comercialización. El agente chino se centra en el registro y el distribuidor en las ventas. En la nueva normativa, la NMPA reforzó el papel del agente chino en la notificación de eventos adversos y el mantenimiento de la distribución del producto de forma indirecta (como representante autorizado de la UE).
The manufacturers are aware of reporting adverse event and recalls since 2019. It is easier for domestic manufacturers when the corresponding departments are among the same house. For overseas manufacturers it is far behind required how to coordinate adverse event - and recalls reporting. Chinese distributor should have agreement with Chinese agent how to handle reporting and to rule the accountability. It means that a procedure of receiving -, analysing -, reportig - as well as handling AE and recalls is needed.
We highly recommend to mandate this role with caution to distributor. On the one hand they don’t have the sound regulatory knowledge. In the most cases they find another consulting firm to do product registration. It exists Ping-Pong communication among three parties. On the other hand they oft keep hold of original
NMPA certificate to block the next product registration and even the process of changing Chinese agent.
Binding obligations of Chinese agent
En el Reglamento sobre la supervisión y administración de dispositivos médicos (Orden del Consejo de Estado 2021/739) se estipula:
Article 20
Los registrantes y titulares de registros de dispositivos médicos deberán cumplir con las siguientes obligaciones:
(1) Establish and adapt product quality management system and applies it effectively;
(2) Elaborar estudios posteriores a la comercialización y un plan de gestión de riesgos, y garantizar su implementación efectiva;
(3) Realizar el seguimiento y la reevaluación de los eventos adversos de conformidad con la ley;
(4) Establish and implement product traceability and recall system;
(5) Other obligations stipulated by the drug regulatory department of the State Council. The domestic legal person designated by overseas manufacturers shall assist the registrant and filing party in fulfilling the obligations stipulated in the preceding paragraph.
domestic legal person = chinese agent
Case study of Chinese agent
Hemos experimentado muchos escenarios sobre a quién asignar como agente chino. Desde la implementación del certificado electrónico para dispositivos médicos, la clásica historia de que el agente antiguo bloquea el certificado en papel para el nuevo agente ya no existe.
Scenario 1 Consulting as Chinese agent
Advantage:
Consulting has solid regulatory knowledge
Easy Switch to new distributor
Desventaja:
Annual holding fee to pay for consulting
Complicated for adverse event communication and reporting
Scenario 2 Distributor as Chinese agent
Advantage:
Gestión simplificada de eventos adversos
Easy for issues related to medical device
Desventaja:
Less regulatory experience
Dificultad moderada para cambiar de agente o distribuidor
Scenario 3 Combination of above, first years consulting, then distributor as Chinese agent
Durante el período de transición, puede probar la consultoría y el distribuidor que cumpla bien con sus responsabilidades y luego transferir gradualmente a un distribuidor confiable.
Our suggestion:
Scenario 3, if you chose us as regulatory partner, we can support either inexperienced subsidiary or external distributor
What to do if to change Chinese agent
Es necesario realizar un breve registro de cambio administrativo en caso de que un fabricante extranjero desee cambiar de agente en China. Se deben considerar las siguientes acciones:
Update label and instruction for use in Chinese
Complete all adverse events with old agent and transfer the account to new agent
Update registering of insurance code and UDI
Ask all electronic product dossiers, info of adverse event, insurance code and UDI from old Chinese agent
Plan del próximo informe anual de gestión de la calidad y del informe periódico de evaluación de riesgos.
Our Service
- Service of qualifing new agent or distributor
- Build of regulatory role at your Chinese partner
- Inspección del socio chino para verificar que cumple con las buenas prácticas de fabricación o distribución.
- Proporcione una lista de verificación y un cuestionario para la selección de su socio chino.
- Interim manager to act any role at your Chinese entity
- Transfer overseas quality policy and product expertise in terms of training or workshop
- Project management
Related link of agent, authorised represenative, In-Country Representation, responsible person and marketing authorization holder (MAH) or registration holder
Agentes estadounidenses
Representantes autorizados de la UE
Persona responsable en el Reino Unido
Contáctanos, también somos expertos en registro global.
