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Filing Process for Imported Toothpastes

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 needed)

  • Account info

  • Quality Management and Adverse Reaction Monitoring System

  • Power of Attorney (notarized)

  • Factory qualification (GMP)

Product Review

  • Product info

  • Formula

  • Original package/ Product label sample

Product Testing

  • Sample info

  • Samples (25 units if net weight is over 20ml)

Documents Review and Completion

  • Implementation standard

  • Free Sale Certificate

  • Chinese label

  • Safety assessment

Dossier Completion and Submission

  • Dossier preparation

  • Sign and stamp

  • Submission

  • Approval certificate issue

  • Technical review


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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