According to Article 10 of the Measures for the Supervision and Management of Toothpastes,
imported toothpaste shall be filed with the National Medical Products Administration (NMPA) before import. Only after obtaining the filing certificate can it be sold in China’s market. In this article, EnterCo will introduce filing process for imported toothpastes.
The filing process for imported toothpaste is generally consistent with the filing process for imported cosmetics. According to the toothpaste regulation, especially Article 6 of the Measures for the Supervision and Management of Toothpastes, issued in March 2023, it is stated that the filing person of overseas toothpastes needs to designate an enterprise legal person within China as the domestic responsible person to handle the filing. The first time for filing, requires an application for the filing account and authority. The specific filing process is as follows:
❑ Account Application (Only first-time recordation needs)
Quality Management and Adverse Reaction Monitoring System
Power of Attorney (notarized)
Factory qualification (GMP)
❑ Product Review
Original package/ Product label sample
❑ Product Testing
Samples (25 units if net weight is over 20ml)
❑ Documents Review and Completion
Free Sale Certificate
❑ Dossier Completion and Submission
Sign and stamp
Approval certificate issue
1. The efficacy evaluation report during the product testing process needs to be prepared separately.
2. Account application and product review can be done at the same period.
3. Product testing and document review and completion can be in the same period.
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