NMPA Cosmetics Filing: Step-by-Step Guide for International Brands

The Chinese Cosmetics Regulatory Landscape

China's cosmetics market is the world's second largest, valued at over $80 billion annually. For international brands, entering this market presents enormous opportunity — but it also means navigating one of the most comprehensive cosmetics regulatory frameworks in the world.

The National Medical Products Administration (NMPA, formerly CFDA) is the regulatory authority responsible for cosmetics oversight in China. Under the Cosmetics Supervision and Administration Regulation (CSAR), which took effect on January 1, 2021, all cosmetics imported into China must be either filed (备案) or registered (注册) with the NMPA before they can be sold.

The classification — filing vs. registration — depends on whether your product is categorized as an ordinary cosmetic or a special-use cosmetic. Understanding this distinction is the first and most important step in your China market entry journey.

Ordinary vs. Special-Use Cosmetics

Ordinary Cosmetics (Notification Filing)

Ordinary cosmetics are the broad category that includes most personal care products. These require notification filing (备案), which is generally faster and less complex than registration. Examples include:

Skincare products (creams, lotions, serums, toners, masks)
Makeup and color cosmetics (foundation, lipstick, eyeshadow, mascara)
Haircare products (shampoo, conditioner, hair masks, styling products)
Perfumes and fragrances
Bath and shower products
Oral care products

The filing process for ordinary cosmetics typically takes 4-6 months from application submission to approval.

Special-Use Cosmetics (Registration)

Special-use cosmetics are products that make specific functional claims and require full registration (注册), a more rigorous process that includes efficacy testing and detailed safety evaluation. Categories include:

Sunscreen and UV protection products
Hair dye products
Freckle removal and skin whitening products
Hair growth products
Anti-hair loss products
Products with new efficacy claims (since CSAR 2021)

The registration process for special cosmetics typically takes 12-18 months and costs significantly more than ordinary filing.

The Chinese Responsible Person Requirement

Regardless of whether your product is ordinary or special-use, you must designate a Chinese境内责任人 (domestic responsible person). This entity:

Is legally responsible for your product's quality and safety in China
Handles all NMPA communications and submissions on your behalf
Manages adverse event reporting and product recalls
Maintains product safety assessment documentation

The responsible person can be:

Your Chinese subsidiary or branch office
A Chinese distributor or partner company
A third-party service provider (such as our firm)

The responsible person must be a legal entity registered in China with a business license that includes cosmetics-related business scope.

Step-by-Step NMPA Filing Process

Step 1: Product Classification

The first step is to accurately classify your product. This determines whether you need filing or registration, which testing requirements apply, and what documentation is needed.

Key classification considerations:

Product function — What claims does the product make?
Product ingredients — Are any ingredients on NMPA's restricted or prohibited lists?
Product form — Is it a cream, liquid, powder, spray, etc.?
Usage area — Skin, hair, nails, lips, etc.

Misclassification is one of the most common reasons for filing delays. An ordinary cosmetic incorrectly classified as special-use (or vice versa) will be rejected and need to be resubmitted.

Step 2: Ingredient Review

Before filing begins, conduct a thorough ingredient review:

Prohibited ingredients — NMPA publishes a list of substances prohibited in cosmetics. Any product containing a prohibited ingredient cannot be filed or registered.
Restricted ingredients — Certain ingredients are allowed only within specified concentration limits
New ingredients — Ingredients not previously used in China may require separate new ingredient registration before the product can be filed
Ingredient nomenclature — Ingredients must be listed using INCI (International Nomenclature Cosmetic Ingredient) names in Chinese

Step 3: Safety Assessment

A product safety assessment (产品安全评估) is required for all cosmetics filed in China. The assessment must be conducted by a qualified safety assessor and includes:

Ingredient safety evaluation
Toxicological risk assessment
Product stability testing
Microbiological testing
Heavy metal content analysis
Preservative efficacy testing

Since 2021, NMPA has been transitioning to a full safety assessment report requirement. As of 2024, complete safety assessments are mandatory for all new filings.

Step 4: Efficacy Testing (Special Cosmetics Only)

For special-use cosmetics, efficacy testing is a critical requirement. Tests must be conducted at NMPA-accredited Chinese laboratories and demonstrate that the product delivers on its claimed function:

Sunscreen products — SPF and PA value testing
Whitening products — Skin lightening efficacy testing
Hair dye products — Colorfastness and safety testing
Anti-hair loss products — Clinical efficacy testing

Efficacy testing is typically the longest single phase of the special cosmetics registration process, often taking 6-9 months.

Step 5: Application Submission

Once all testing and documentation are complete, the application is submitted to NMPA through the Chinese responsible person. The submission package includes:

Product formula (complete ingredient list with concentrations)
Product safety assessment report
Efficacy test reports (special cosmetics)
Product packaging and labeling samples
Manufacturing process description
Quality management system documentation
Power of attorney for the responsible person
Free sales certificate from the country of origin

Step 6: NMPA Review and Approval

NMPA reviews the application for completeness and compliance:

Ordinary cosmetics (filing): NMPA reviews for completeness. If all documents are in order, the filing is granted and a filing number is issued. Timeline: approximately 4-6 months.
Special cosmetics (registration): NMPA conducts a substantive review of the safety assessment, efficacy testing, and all documentation. Timeline: approximately 12-18 months.

Step 7: Post-Filing Compliance

After filing or registration is approved, ongoing compliance obligations include:

Annual reporting — Submit annual reports on product sales, adverse events, and any changes
Adverse event monitoring — Report any adverse reactions to NMPA within specified timeframes
Label compliance — Ensure product labels meet Chinese cosmetics labeling requirements
Change notification — Notify NMPA of any formula changes, manufacturing site changes, or responsible person changes
Renewal — Filing certificates for ordinary cosmetics are valid indefinitely but require annual reporting. Registration certificates for special cosmetics are valid for 5 years and must be renewed.

Common Filing Challenges

1. Animal Testing Requirements

China has significantly relaxed animal testing requirements since 2021. Ordinary imported cosmetics manufactured under Good Manufacturing Practices (GMP) with a complete safety assessment may be exempt from animal testing. However:

Products for infants and children still require animal testing
Products using new ingredients may require animal testing
Special-use cosmetics generally still require animal testing

We evaluate your products for animal testing exemption eligibility as part of the filing process.

2. Formula Changes After Filing

Once a product is filed or registered, any formula change — even a minor one — requires notification to NMPA and may trigger re-filing or re-registration. Plan your product formulations carefully before filing.

3. Packaging and Labeling

Chinese cosmetics labeling requirements include:

Full ingredient list in Chinese (using INCI names)
Product name in Chinese
Net content
Manufacturer information
Chinese responsible person information
Production date and batch number
Usage instructions and precautions
Shelf life information

Label non-compliance is one of the most common reasons for customs rejection of cosmetics imports.

4. Cross-Border E-commerce as an Alternative

If NMPA filing timelines don't align with your market entry goals, consider cross-border e-commerce (CBEC) as a faster alternative. CBEC allows cosmetics sales without NMPA filing under certain conditions. Many brands use CBEC as a market testing channel while preparing full NMPA compliance.

How We Can Help

We provide comprehensive NMPA cosmetics filing services:

Product classification — Determine filing vs. registration requirements
Ingredient review — Verify all ingredients against NMPA prohibited and restricted lists
Safety assessment coordination — Work with qualified assessors to prepare complete safety reports
Testing coordination — Arrange required testing at NMPA-accredited Chinese laboratories
Responsible person service — Serve as your Chinese境内责任人
Full filing management — Handle all documentation, submission, and NMPA communication
Post-filing compliance — Manage annual reporting, change notifications, and renewals

Whether you're filing a single product or registering an entire product line, we streamline the process and keep you informed at every stage.