Guide to Cosmetic Product Registration in Malaysia 

If you're planning to sell cosmetic products in Malaysia, it is mandatory to notify the National Pharmaceutical Regulatory Agency (NPRA) before your products reach the market. The good news is that notification is one of the lighter regulatory processes in Southeast Asia: there is no pre-market approval, and most products clear the process in a few weeks if all documents are in order.

This guide covers the full cosmetic product registration process in Malaysia. We walk through product classifications, key compliance requirements, and how to submit a notification to the NPRA.

Legal Framework for Cosmetic Product Registration in Malaysia

Cosmetic products in Malaysia fall under the Control of Drugs and Cosmetics Regulations (CDCR) 1984, made under the Sale of Drugs Act 1952. The Drug Control Authority (DCA) oversees the regulation, and the NPRA acts as its operational arm, running the notification process and carrying out post-market surveillance.

Malaysia moved from product registration to a notification-based system in January 2008, in line with the ASEAN Cosmetic Directive (ACD). In practice, that means you declare your product's compliance with the regulations rather than waiting for government sign-off before you sell. 

That said, the NPRA still screens every notification, and it rejects those that fail, whether for a prohibited ingredient, improper labeling, or incomplete documentation.

Please note that selling your products without proper notification and approval has severe consequences. A first offence can bring a fine of up to RM 25,000, imprisonment for up to three years, or both, and up to RM 50,000 for a company. Stock can also be seized at the border.

What is Classified as a Cosmetic Product?

Under the ASEAN Cosmetic Directive, a cosmetic is any substance or preparation meant to be placed in contact with the external parts of the body: the skin, hair, nails, lips, external genital organs, or the teeth and the mucous membranes of the mouth.

Its purpose has to be only or mainly cleaning, perfuming, changing appearance, correcting body odour, or keeping those areas in good condition. Common categories include:

• Skincare (moisturizers, serums, sunscreens)
• Makeup and colour cosmetics (foundations, lipsticks, blush)
• Hair care (shampoos, conditioners, hair dyes)
• Fragrances and perfumes
• Deodorants and antiperspirants
• Personal hygiene products (soaps, toothpaste, mouthwash)
• Nail care products

Cosmetics vs. Medicinal Products

If your product makes any therapeutic, pharmacological, or medicinal claim, it is not a cosmetic. It moves instead to the NPRA's pharmaceutical or health supplement pathway, which is a far heavier process.

What decides the classification is the claim you make, not what the product contains. A moisturizer sold for "hydration and skin protection" is a cosmetic. The same moisturizer sold to "treat eczema" or "cure acne" is not. Products that contain Scheduled Poisons under the Poisons Act 1952, or that exceed medicinal dose thresholds, are also reclassified.

If you are unsure which side your product falls on, it is worth settling the classification before you start. Emerhub's local advisors can confirm your product classification and the correct regulatory route.

Who Can Register Cosmetic Products in Malaysia?

Any business that manufactures, imports, distributes, or sells cosmetic products in Malaysia must notify the NPRA before those products can enter the market. This applies to:

1. Local manufacturers that produce cosmetics domestically.
2. Importers and distributors that bring in foreign-produced cosmetics and supply them locally.
3. Contract manufacturers that produce cosmetics on behalf of other brands.
4. Wholesalers that sell or supply notified cosmetic products. Those who do not directly notify, manufacture, or import the product must hold a separate wholesale authorization.

The key requirement across all of these is that the entity submitting the notification must be a locally incorporated company. Foreign companies cannot directly submit cosmetic notifications to the NPRA. To enter the market, you must either incorporate a local entity or appoint a Cosmetic Notification Holder (CNH), also referred to as local authorized representative, to manage the notification process and ongoing compliance on your behalf.

Key Requirements for Cosmetic Product Registration in Malaysia

Before you can submit a notification to the NPRA, you need to have several things in place. These requirements apply to both locally manufactured and imported cosmetic products.

1. Appointing a Cosmetic Notification Holder

The CNH is the company responsible for placing the cosmetic product on the Malaysian market. The CNH may or may not be the product owner. For foreign brands, the CNH typically acts as your regulatory representative in Malaysia, managing all interactions with the NPRA.

To qualify as a CNH, the company must meet these criteria:

• It must be registered with the Companies Commission of Malaysia (SSM) or the Malaysian Registrar of Business (ROB)
• It must have a permanent business address in Malaysia
• Its business scope (as reflected in its SSM profile) must be related to health or cosmetic products

If the CNH is not the product owner, a Letter of Authorization (LOA) from the product owner is required. This letter authorizes the CNH to notify the product to the NPRA and handle all related regulatory matters on behalf of the brand.

2. Product Information File (PIF)

The Product Information File is a mandatory regulatory dossier that must be compiled before notification and kept readily accessible for NPRA inspection at any time. The PIF must be in Bahasa Malaysia or English. A complete PIF includes:

• The qualitative and quantitative composition of the product (for perfume compositions, the name and code number of the composition and the identity of the supplier)
• Specifications of raw materials and the finished product
• The manufacturing method, confirming compliance with Cosmetic Good Manufacturing Practice (GMP) guidelines or equivalent standards
• A safety assessment demonstrating the product is safe for use under normal or reasonably foreseeable conditions
• Data on any undesirable effects reported in connection with the product
• Evidence supporting any claims made about the product

The PIF is not submitted as part of the notification. It stays with the CNH and must be produced on request by the NPRA during inspections or post-market surveillance. Keeping this file current is crucial, as any updates to your formulation, manufacturers, raw material suppliers, or production process must be reflected in the PIF.

3. Labeling Compliance for Cosmetics in Malaysia

The CNH is responsible for ensuring that each product's packaging meets the NPRA's labeling standards before notification. All label information must be in Bahasa Malaysia and/or English. The label must include:

• The name and function of the product (unless clear from its presentation)
• Instructions for use (unless clear from the product name or presentation)
• A full list of ingredients
• The country of manufacture
• The name and address of the CNH
• The manufacturing date or expiry date in clear terms (e.g., month/year)
• Batch or lot number
• Any special precautions or warnings for use

Labels must not include any medicinal or therapeutic claims. Product names or claims containing words like "treatment," "cure," "prevention," or references to medical benefits can lead to notification rejection or regulatory action from the NPRA.

4. Compliance with Good Manufacturing Practice (GMP)

All cosmetic products sold in Malaysia must be manufactured in accordance with Cosmetic Good Manufacturing Practice (GMP) guidelines or equivalent standards.

For local manufacturers, the NPRA conducts GMP inspections. New manufacturers or new production lines must pass an NPRA inspection before they can submit a cosmetic notification. After that initial inspection, manufacturers are subject to periodic regulatory audits to ensure continued compliance.

For foreign manufacturers, the process is different. You don't need a physical NPRA inspection, but you must be able to provide documentation proving your facility complies with cosmetic GMP standards (or equivalent). This document must be issued or endorsed by an authorized body or agency in the country of manufacture. Your local product holder is responsible for keeping this documentation available for the NPRA upon request.

How to Register Cosmetic Products in Malaysia

As your authorized CNH, Emerhub helps ensure you meet all local requirements and handle the notification process end-to-end. Here’s an overview of the step-by-step process with Emerhub as your local partner:

1. Confirm Product Classification and Ingredient Compliance

Before anything else, we verify that your product qualifies as a cosmetic under Malaysian regulations. Our team cross-checks your ingredient list against the ASEAN prohibited substances list (Annex II) and restricted substances list (Annex III) to confirm your formulation is compliant. Your product must not make any therapeutic or medicinal claims, and all restricted ingredients must fall within allowable limits and conditions.

The table below highlights some commonly flagged restricted substances and recent updates that foreign brands should be aware of:

Note that the above is not an exhaustive list. The ASEAN prohibited and restricted substance annexes are updated periodically following ASEAN Cosmetic Committee meetings, which take place twice a year. We verify your formulation against the latest version of these annexes before proceeding.

If your product contains ingredients that do not yet appear in the NPRA database, prior approval from the NPRA is required before the product can be notified. This can add weeks to the overall timeline, so we flag these early to keep your timeline on track.

2. Prepare the Cosmetic Notification Documents

After verifying the cosmetic product classification, we compile the complete set of documents required for submission. Here are the documents needed for cosmetic product notification:

• Product particulars (product name, type, intended use, and product presentation)
• Name and address of the manufacturer(s) and assembler(s), if any
• CNH details (name, address, valid contact number, and email)
• Details of the person representing the CNH, including a valid contact number
• The full product ingredient list, with percentages declared for any restricted ingredients
• A Letter of Authorization (LOA) from the product owner, authorizing Emerhub as CNH
• A Letter of Declaration or Contract Manufacturing agreement, where applicable
• For foreign manufacturers, a GMP certificate or equivalent document endorsed by an authorized body in the country of manufacture

All documents submitted to the NPRA must be in Bahasa Malaysia or English. Translated versions from other languages must be endorsed or authorized by the relevant party. As your local representative, we review all documentation for completeness and accuracy before submission to avoid delays or rejections.

3. Application Submission for NPRA Screening

Once everything is in order, we submit the notification through the QUEST 3+ system. This includes inputting all product and company details, uploading the required documents, and confirming the submission.

The NPRA then screens the notification before it takes effect. 

NPRA checks cover the following:

• Formulation against the ASEAN prohibited and restricted substance annexes
• Whether the product name and presentation carry any therapeutic or medicinal claims
• The completeness of the manufacturer and CNH details
• The GMP documentation (if products are imported)

4. Issuance of Cosmetic Product Notification Note

After the NPRA confirms the submission, the Notification Note is issued, usually within one to three working days. This is your official authorization to manufacture, import, sell, and wholesale the product in Malaysia. It carries the product's NOT number (for example, NOT230100001K), the unique identifier for every notified cosmetic in the country 

Unlike pharmaceutical products, you won’t have to display the NOT number on cosmetic labels. However, consumers and regulators can verify your product's notification status at any time through the QUEST 3+ product search. Some brands choose to include the NOT number on their packaging voluntarily to build consumer confidence.

Each notification is valid for two years, and the renewal has to be filed no later than one month before expiry. 

As your cosmetic product holder, we track the expiry dates across your product range and file the renewals before the window closes, so a lapsed notification never takes a product off the market.

After Notification: Your Ongoing Obligations

After approval, you have three primary ongoing obligations: reporting changes to the product, handling adverse events and recalls, and keeping the formulation compliant as the rules evolve.

Changes to the Product

Any change to a notified product's particulars must go to the NPRA, and the treatment depends on the change. Smaller updates are handled as amendments to the existing notification, and the NOT number stays the same. Bigger changes, such as a reformulation, need a new notification and a new NOT number. 

We advise on which side a planned change falls before you commit to it.

Adverse Events and Recalls

The CNH is responsible for recording and reporting undesirable effects linked to the product, and for running a recall of any defective or unsafe product. No recall should happen without first consulting the NPRA.

Keeping the formulation compliant

The ingredient rules keep moving after your product is notified. The ASEAN annexes are revised twice a year, and substances that were permitted can become restricted or prohibited, as 4-MBC and Miconazole recently were. 

A product whose formulation falls out of line with the current annexes breaches its notification, even though nothing about the product itself changed. When that happens, the NPRA's Director of Pharmaceutical Services can cancel the notification at any time and order the recall and disposal of the affected stock. 

Malaysia publishes a running list of cancelled notifications, and prohibited substances are the most common reason on it. Therefore, the formulation needs to be rechecked against each annex update, and reformulated within the grace period where a change affects it.

Halal Certification for Cosmetics in Malaysia

Halal certification for cosmetics in Malaysia is voluntary. The NPRA does not require it as part of the notification process. However, given that over 63% of Malaysia's population identifies as Muslim, halal certification can give your brand a meaningful competitive edge.

If you choose to pursue halal certification, your products must be approved by the Department of Islamic Development Malaysia (JAKIM) or an Islamic body recognized by JAKIM. The certification covers ingredients, sourcing, manufacturing processes, storage, packaging, and logistics. All components must be free from haram (prohibited) substances, and the production facility must prevent cross-contamination with non-halal materials.

Only products that have been certified by JAKIM or a JAKIM-recognized body can display the Halal logo on their packaging. Using the logo without valid certification is a regulatory violation.

Emerhub can help you assess the feasibility of halal certification for your product line and manage the application process alongside your cosmetic product registration in Malaysia.

How to Import Cosmetic Products into Malaysia

Imported cosmetics follow the same notification pathway as locally manufactured ones. Your product must be notified to the NPRA before it can clear customs. A MITI-approved permit is not required, as cosmetic products fall outside the scope of the Customs (Prohibition of Imports) Order.

Once the NPRA confirms your notification and payment, the system generates a Notification Note along with a NOT number for your product. This serves as your authorization to import. 

Register Your Cosmetic Products in Malaysia with Emerhub

Emerhub supports foreign cosmetic brands entering Malaysia through the full notification process. As your local authorized representative, we start by confirming your product classification and screening your formulation against the latest ASEAN ingredient annexes. From there, we prepare and review your notification documents before submitting them through the QUEST 3+ system.

Our support continues after your product reaches the market. We track notification expiry dates and handle renewals ahead of schedule to prevent any gaps in authorization. We also manage post-notification amendments and keep your Product Information File current as your formulation, suppliers, or manufacturing details change.

Ready to enter the Malaysian cosmetics market? Fill out the form below to book a free consultation with our team in Malaysia.