Earlier this year, the Shanghai Medical Products Administration fined a foreign cosmetic registrant whose designated Domestic Responsible Person (DRP) failed to assist in adverse event monitoring and product recalls.
This case highlights a crucial reality for overseas brands entering China: the China RP is not just a formal contact — it is the legal "first responder" for compliance and product safety, bearing direct administrative liability under Chinese law. Understanding the obligations and risks associated with this role is essential for any foreign brand seeking a smooth and compliant entry into the Chinese market.
Under China's Administrative Measures on Cosmetics Registration and Notification(2021), foreign registrants/notifiers must designate a Chinese corporate legal person as their Domestic Responsible Person(commonly known as China RP). The China RP serves as the legal bridge and the responsibility holder for foreign brands (applies to toothpaste as well).
Foreign cosmetic brands entering the Chinese market can appoint a China RP either by establishing an in-house subsidiary or by engaging a professional third-party service provider.
Setting up a subsidiary offers strong internal control, ensures risk management within the corporate group, and provides better protection for trade secrets. However, it requires a larger investment in company registration, staffing, and compliance resources.
By contrast, appointing a third-party RP is a more flexible and cost-efficient approach, allowing faster market entry. Nonetheless, it requires careful evaluation of the provider's regulatory expertise, operational stability, and contractual safeguards. Inadequate management or frequent personnel turnover on the provider’s side could expose the foreign brand to compliance and legal risks.
Once the model is determined, the foreign registrant or notifier must formally authorize the designated China RP. The process generally includes:
1. Execute and notarize the Authorization Letter: The foreign company signs and notarizes a Domestic Responsible Person Authorization Letter to grant legal authority to the China RP.
2. Register on the NMPA platform: The China RP registers on the NMPA Cosmetic Registration and Notification Information Service Platform to initiate the process.
3. Submit required documents: Including the DRP Information Form, the notarized authorization letter, the business license, and other supporting materials.
4. Await regulatory approval: Upon NMPA review and approval, the China RP officially assumes its legal responsibilities.
Under China's Administrative Measures on Cosmetics Registration and Notification(2021), China RP shall fulfill the following statutory duties:
1. Registration and Notification: Handle the registration and Notification of cosmetics and new cosmetic ingredients in the name of the registrant or notifier.
2. Safety Monitoring: Assist in monitoring and reporting adverse reactions of cosmetics and safety monitoring of new ingredients.
3. Product Recall: Support the registrant or notifier in implementing product recalls when necessary.
4. Quality and Safety Accountability: Undertake corresponding quality and safety responsibilities for products placed on the Chinese market, as agreed with the registrant or notifier.
5. Regulatory Cooperation: Cooperate with supervision and inspection conducted by the NMPA.
In practice, these obligations mean the China RP is not only an administrative contact point but also the legal bearer of compliance risk within China. Failure to properly perform these duties—such as submitting inaccurate registration documents or neglecting post-market surveillance—may result in penalties similar to the enforcement case mentioned at the beginning.
The authorization of a China RP is valid for the period stated in the Letter of Authorization. Once expired, the foreign registrant or notifier must renew it to maintain compliance.
Renewal:
Renewal should be completed within 30 days before expiry by submitting a notarized authorization letter via the NMPA registration platform. If not renewed on time, the RP cannot handle new notification or registrations, though ongoing cases may continue until completion.
Document Updates:
For overseas manufacturers, GMP or production qualification documents with an expiry date must be renewed within 90 days after expiration. If no validity period is stated, updated versions must be submitted every five years.
Change of Authorization:
When changing the authorization scope or replacing the RP, a full transfer procedure must be completed. This includes a consent letter from the former RP and a commitment letter from the new RP assuming full product safety responsibility.
For overseas cosmetic brands planning to enter the Chinese market, complying with local regulations is critical from day one. ZMUni can act as your China Domestic Responsible Person (China RP) and provide comprehensive support throughout the product lifecycle.
Our services for imported cosmetics include:
Cosmetic Product Registration and Notification
Cosmetic Formula & Label Review
Cosmetic Safety Assessment
Cosmetic Efficacy Evaluation
Toothpaste Compliance Services
Customs Clearance for Cosmetics
With our local presence and regulatory expertise, we help global instakeholders meet China's regulatory requirements and expectations with confidence. For inquiries, please contact us at info@zmuni.com.
