1. Certification Overview
In Malaysia, the definition of cosmetics refers to ‘any substance or preparation used alone or primarily for the purpose of contacting various external parts of the human body (epidermis, hair, nails, lips, and external genitalia) or teeth and oral mucosa, or for the purpose of washing, protecting, deodorizing, altering appearance, or maintaining good condition of such areas.’
All cosmetics distributed in Malaysia are regulated by the National Pharmaceutical Regulatory Authority of Malaysia (NPRA) through product registration, in accordance with the ASEAN Cosmetic Directive (ACD) prescribed by the ASEAN Cosmetic Committee (ACC).
The company responsible for launching cosmetics into the market in Malaysia is called a CNH, and the CNH must be a local company or legal entity in the cosmetics sector registered with the Companies Commission of Malaysia and have an address in Malaysia. Therefore, it is essential for foreign companies wishing to export cosmetics to Malaysia to designate a local agent (a company registered in Malaysia).
Since cosmetic declarations can only be filed online through the Quest3+ system, applicants must register as users on Quest3+.
2. Regulatory Agencies & Basic Information
| Regulatory Agencies | NPRA (National Pharmaceutical Regulatory Agency) |
| Testing Agency | 1. SIRIM Berhad 2. SGS (MALAYSIA) SDN. BHD. 3. TUV RHEINLAND MALAYSIA SDN. BHD. |
| Lead time | About 1 to 6 months |
| Price | Reporting Fee: 50.00MYR |
| Agent | Designation of a local agent (a company registered in Malaysia) is mandatory. |
3. Reporting Process
- Product Classification
- Selection of Local Responsible Person (RP) for Malaysia
- Prepare Product Information File (PIF)
- Safety assessment
- Cosmetics Reporting (Using Quest3+ Portal)
- Print Approval and Report
4. Required Documents
| Safety assessment | PIF Part Ⅰ. Management Documents and Quality Overview | • Administrative documents • Qualitative and quantitative ingredient lists for products • Product markings and labels, etc. |
| PIF Part Ⅱ. Raw material quality data | • Specifications and test methods for raw materials/ingredients • Safety data of raw materials based on data provided by the raw material supplier, published data, or reports from scientific committees such as SCCP, ACSB, and CIR |
|
| PIF Part Ⅲ. Quality data of the final product | • Qualitative and Quantitative Ingredient List • Manufacturing Information • Finished Product Specifications and Test Methods, etc. |
|
| PIF Part Ⅳ. Safety and efficacy data | • Safety Assessment • Adverse Event Reports • Supporting Data for Product Efficacy Claims |
|
| Product Report | • Product Details 1) Product Name 2) Product Type 3) Use and Product Description, etc. • Name and Address of Manufacturer and Packaging Company (if applicable) • Name, Address, and Valid Contact Number (and Email Address) of the Reporting Officer • Details of the Representative of the Reporting Officer Enterprise, including a contactable number • Name and Address of Importer (if applicable) • Full List of Product Ingredients (Percentage of restricted ingredients must be reported) • Power of Attorney/Declaration/Contract Manufacturing Order (if applicable) • Product Label |
|
5. Validity Period
- Validity Period: 2 years
- Renewal: Apply for renewal at least one month before expiration
Source
Malaysia Cosmetics Management Guidelines
NPRA Cosmetics Main Page
NPRA Cosmetics Guidelines