Cosmetic products in Malaysia are under the unified regulation of the National Pharmaceutical Regulatory Agency (NPRA), which operates under the purview of the Ministry of Health Malaysia. Its core responsibilities include the review of cosmetic market access, quality management, post-marketing supervision, adverse reaction monitoring, and the formulation and enforcement of regulatory frameworks.Official Website of the Regulatory Authority: https://www.npra.gov.my/Database Portal: https://quest3plus.bpfk.gov.my/pmo2/index.php
ASEAN Cosmetic Directive (ACD)Control of Drugs and Cosmetics Regulations 1984 (CDCR)Sale of Drugs Act 1952
A cosmetic product in Malaysia is defined as any substance or preparation intended to come into contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity, with the sole or main purpose of cleansing, perfuming, improving appearance / eliminating body odour, protecting or keeping them in good condition.
A valid ISO 22716 certificate for cosmetic quality management system;Submission of product details, manufacturer information, finished product quality test data, stability data, safety assessment data, efficacy claim supporting data and raw material quality documentation;Appointment of a compliant Cosmetic Notification Holder (CNH) and provision of its detailed information;Submission of the full product ingredient formulation list, packaging and compliant labels.
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Power of AttorneyPackaging artworkIngredient list
The CNH is the entity responsible for placing cosmetic products on the Malaysian market, and must meet the following requirements:Be a local company or legal entity incorporated and registered in Malaysia;Have a fixed business address and be registered with the Companies Commission of Malaysia (SSM);Explicitly specify health or cosmetic-related business scope in its Memorandum and Articles of Association.
1.Notification Procedure
Standard procedure: The Cosmetic Notification Holder (CNH) logs into the QUEST 3+ system → completes the notification form in full and pays the applicable fee → the NPRA conducts compliance screening → upon successful screening, a notification letter is generated (to be printed by the CNH independently) → the product may be manufactured, imported and sold in Malaysia; if the screening fails, the notification application will be rejected.
2.Notification Timeline and Official FeesOfficial review period: Generally 1 to 3 months, subject to the complexity of the product and the completeness of submitted documentation.Official fees: The processing fee for the initial notification of a single product is 50 Malaysian Ringgit (RM); the notification renewal fee is also 50 RM per product.
3.Variation Rules for Notified Products
（1）Type 1 VariationProcessing method: Only modifications to the existing notification information are required, with no need to resubmit a full application.Official fee: No fee is charged for this type of variation.Notification number: The original notification number remains unchanged.Applicable variation items: Product presentation form (e.g. single product, series set, etc.)Company representativeImporter/distributorLetter of authorization, statement letter, or contract manufacturing agreementProduct label（2）Type 2 VariationProcessing method: A new notification application must be resubmitted for official review.Official fee: 50 Malaysian Ringgit (RM) per product.Notification number: A new notification number will be issued upon approval.Applicable variation items: Brand nameCompany change resulting from the transfer of distribution rightsProduct typeIntended use of the productProduct nameProduct formulationManufacturer or packager (change of name or registered address)