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- Potential Changes to the In-Country Agent Role in China in 2025
Potential Changes to the In-Country Agent Role in China in 2025
Elaine Tan
March 12, 2025
On August 26, 2024, the National Medical Products Administration (NMPA) released a draft revision of the “Law of the People's Republic of China on the Management of Medical Devices”. With the public consultation phase concluded last year, the proposal is undergoing feedback review. If the current draft is implemented without further revisions, it will introduce regulatory changes impacting foreign medical device manufacturers seeking market entry into China.
Key Proposed Changes
Redefinition of the In-Country Agent Role
The existing term In-Country Agent is set to be revised to In-Country Responsible Person (ICRP) to reflect a substantial shift in responsibilities. Previously, the agent was primarily a representative with limited obligations. Under the proposed changes, the ICRP will share joint responsibility with the foreign manufacturer for regulatory compliance and post-market obligations.
Expanded Eligibility for the ICRP Role
Under the new draft, holders of a medical device manufacturing license in China will also be eligible to serve as the ICRP. Previously, only the entities with a medical device operating license could take on this role.
Mandatory Advertisement Approval
The local registrant, filer, or ICRP of an imported medical device must go through the ad screening and obtain an advertisement approval number from the Advertisement Review Authority before releasing marketing materials of the medical device to the public.
Increased Compliance Obligations
The NMPA has outlined a comprehensive list of responsibilities that the ICRP for imported medical devices must fulfill, reinforcing their regulatory and operational accountability. I’ve put together a table with existing and newly proposed requirements for your comparison as below:
Before | After |
|---|---|
In-country agent shall handle the document submission for the registration or filing for the Class I, II, III medical devices of the foreign applicants | In-country responsible person shall submit the registration or filing document to NMPA for the Class I, II, III medical devices of the foreign applicant |
Assist foreign medical device manufacturer in establishing a quality management system appropriate to the product and maintain its effective operations | Assist the registrant of imported medical devices/ foreign medical device manufacturer applicant in establishing quality management system appropriate to the product and maintain its effective operations |
Assist foreign medical device manufacturer in developing post-market research and risk control plan and ensure its effective implementation | Carry out post-market risk control of imported medical devices |
Assist foreign medical device manufacturer in performing adverse event monitoring and re-evaluation procedure | Undertake the monitoring and reporting of adverse events related to imported medical devices, collaborate with drug supervision and management departments, medical device alert technical institutions to perform investigation and handling of adverse events |
Assist foreign medical device manufacturer in establishing and implementing the product traceability and recall system | Organize and execute the recalls of imported medical devices in China |
Assist foreign medical device manufacturer in other obligations defined by the State Council drug supervision and management department | Perform other obligations defined by the State Council drug supervision and management department |
No obligation regarding the involvement of the in-country agent as legal advocate, as well as in inspection and violation screening | Assist NMPA to perform inspection and handling of law violation on the registrant of imported medical devices and receive relevant legal documents on behalf of the registrant of imported medical devices |
Not a written requirement, but the in-country agent has proactively assisted with the communication with NMPA | Act as a communication liaison between NMPA and registrant of imported medical devices and inform registrant about the relevant laws, regulations and technical aspects of the requirements on time. |
Previously, focus on how the in-country agent should assist foreign medical device manufacturers, no emphasis on the collaboration and joint liability | The registrant of the imported medical devices shall provide necessary support to allow in-country responsible person fulfilling the above obligations. In-country responsible person and the registrant of the imported medical devices bear joint and several responsibilities. |
Impact on Foreign Medical Device Manufacturers
Historically, the role of the In-country Agent was primarily focused on device registration and filing while assisting foreign manufacturers in meeting regulatory obligations. However, under the proposed changes, the ICRP will assume greater responsibilities, ensuring compliance with China's regulatory framework, and sharing liability with the foreign medical device registrant.
If you have doubts about what qualifications a competent In-country Agent must possess, here is a post dedicated to you.
What This Means for You
The ICRP will need to have qualified regulatory and quality experts, as well as established processes and necessary certifications, to meet the new compliance requirements.
Foreign medical device manufacturers must carefully evaluate potential ICRPs, ensuring they possess the expertise and capabilities to fulfill the expanded obligations.
Companies should proactively assess how these regulatory changes affect their China market strategy and prepare for potential implementation in 2025.
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Disclaimer: This content is created solely in my personal interest and do not reflect the views, opinions, or policies of my employer or any other organizations I am affiliated with. The information provided is for general informational purposes only and should not be construed as professional advice. Neither I nor my employer is liable for any use of this content. This newsletter is non-commercial and does not compete with my employer’s interests. Any references to regulatory updates or guidance are based on publicly available information and are not intended to infringe upon proprietary or confidential content.