EasyChinapprov           

Agile project of global registration of medical device
Chinese agent

Chinese Agent

= Marketing authorised holder (MAH), legal representative


A key Factor for Success of Chinese Commercialization of Medical Device

Chinese Agent of medical device

Chinese Agent for foreign legal manufacurers in China


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.

Chinese authorised representative

Task of Chinese agent


The regulatory responsibility and requirements of Chinese agent is increasing

Responsibility of Chinese agent:


 •    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

Nice to have

·        Assessment to significant change of approved medical device in China

·        Prove of IFU and label


Controversial responsibility of adverse event reporting (tender) for overseas manufacturers


It is a dilemma who should actively coordinate adverse event at post market activities. Chinese agent focuses on registration and Distributor focuses on sales. At new issued regulation, NMPA strengthed the role of Chinese agent for adverse event reporting and maintenance of product distribution indirectly (as EU authorized representative).


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. 


Chinese agent, legal manufacturer and distributor

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 obligation of Chinese agent

At Regulations on the Supervision and Administration of Medical Device (State council order 2021/739) it stipulates:


Article 20

Registrants and record holders of medical device shall perform the following duties:


 (1) Establish and adapt product quality management system and applies it effectively;

 (2) Development of post-marketing studies and risk management plan and to ensure the effective implementation;

 (3) Carry out adverse event monitoring and re-evaluation in accordance with the law;

 (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


We have experienced many scenarios whom to assign to be Chinese agent. Since electronic certificate of medical device, the classic story that old agent block paper certificate to new agent doesn’t exist.


Scenario 1 Consulting as Chinese agent


Advantage:

Consulting has solid regulatory knowledge

Easy Switch to new distributor

 

Disadvantage:

Annual holding fee to pay for consulting

Complicated for adverse event communication and reporting


Scenario 2 Distributor as Chinese agent


Advantage:

Simplified adverse event management

Easy for issues related to medical device


Disadvantage:

Less regulatory experience

Moderate difficulty to switch either new agent or new distributor

 

Scenario 3 Combination of above, first years consulting, then distributor as Chinese agent


In the transition period you can test consulting and distributor who fulfills his responsibility well and then transfer slowly to reliable distributor


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


A brief administrative change registration is needed in case foreign manufacturer wants to change Chinese agent. The following actions should be considered:

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 of next quality management annual report and periodic risk assessment report



Our Service

  • Service of qualify new agent or distributor
  • Inspection of Chinese partner compliant as to good manufacturing or distribution practice
  • Provide checklist and questionnaire for your own selection of Chinese partner
  • Interim manager to act any role at your Chinese entity
  • Transfer overseas quality policy and product knowledge 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


U.S. Agents

EU Authorised Representatives

UK Responsible Person


Contact us, we are expert of global registration too.


Service of legal representative How to find Chinese partner After approval activities in China
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