Regulatory Affairs Services in Malaysia

Comprehensive regulatory services solutions in Malaysia for efficient, hassle-free healthcare products registration and approval.

Services We Offer

Register your Product in Malaysia

Registering a product in Malaysia can be a complex process due to the involvement of multiple regulatory requirements. The government of Malaysia is proactively promoting the healthcare industry leading to the increased investment in R&D of pharmaceutical products and hence improving the regulatory requirements.

Malaysia’s product approval process is regulated by the National Pharmaceutical Regulatory Agency (NPRA) under Malaysia’s Ministry of Health (MoH). It is the central authority for the regulation of drugs, biologics, and cosmetics. Medical devices are regulated by the Medical Device Authority (MDA), and the food supplements and nutrition products come under the Food Safety and Quality Division (FSQD) of the MoH. The Department of Veterinary Services (DVS) regulates veterinary products.

Artixio provides smooth product approval solutions that meet the Malaysian-specific regulatory authority requirements. Contact us today to approve your product in Malaysia.

Regulatory Authorities in Malaysia

Each authority has specific guidelines, which determine the product classification, documentation, licensing, and post-market obligations.

Authority	Scope
NPRA (National Pharmaceutical Regulatory Agency)	Regulates pharmaceuticals, biologics, health supplements, and cosmetic products
MDA (Medical Device Authority)	Regulates all classes of medical and in-vitro diagnostic (IVD) devices.
FSQD (Food Safety & Quality Division)	Responsible for the regulation of nutrition, food products, and certain supplements
DVS (Department of Veterinary Services)	Regulates veterinary products

Product Registration and Approval Lifecycle

Product approval timelines and formats vary with the product category. However, the product registration process in Malaysia involves the following general regulatory lifecycle:

Step 1 - Product Classification

Identify the correct product category before submitting the application. This step is necessary to understand the required documentation and to prevent the approval delays. The classification can be done as follows:

Step 2 - Appoint a Local Authorized Representative (LAR)

Foreign companies require a designated Malaysia-based Local Authorized Representative (LAR) to manage the product application. They also hold the marketing authorization and must have a valid import license, where applicable.

Step 3 - Application Submission & Evaluation

Submit the application with detailed documentation including product formulation and ingredients, manufacturing process and GMP certification, clinical data and efficacy studies, labelling and packaging information.

Step 4 - Product Approval and Licensing

Once approved, products receive the product registration number, certificate of notification for cosmetics, Veterinary Product Registration Certificate. The licenses are valid for five years and should be renewed before the expiry.

Step 5 - Post-Marketing Compliance

After the product is launched in the market, companies are responsible to report adverse events related to the product, submit Periodic Safety Update Reports (PSURs), maintain GMP compliance and file the variations in products such as formulation, labeling, or manufacturing site changes.

Artixio provides full lifecycle maintenance, including variation management and renewal tracking.

Why Artixio

Are you launching your product in Malaysia? It involves more than just meeting global standards. Our team at Artixio ensures smooth market entry, sustained product approval success and customized alignment with local authority expectations. Contact our Malaysia regulatory affairs expert today. Let’s get your products approved with confidence and speed.

FAQs

What is Quest3+?

Quest3+ is the NPRA’s online portal to submit and track the pharmaceutical, biologic, and cosmetic product registrations.

What are the language requirements for labeling and documentation?

Labels must be in Bahasa Malaysia and/or English. Regulatory documents may be submitted in English, but certain elements (e.g., patient information) should be localized.

Does Malaysia offer any fast-track or priority review pathways?

Yes, NPRA offers priority review for orphan drugs, pandemic-response products, and medicines addressing unmet medical needs. The eligibility of the products must be pre-approved by the regulatory authority.

Which portals are required for submitting the application?

Submissions are made through the following portals:

Quest3+ for NPRA-regulated products
MeDC@St 2.0 for medical devices
FoSIM for food supplements
Manual submission or e-portal (DVS) for veterinary products.

What are the dossier preparation formats ?

Depending on the product type, follow the below dossier formats for different product categories:

Pharmaceuticals: CTD (Common Technical Document) format
Medical Devices: CSDT (Common Submission Dossier Template)
Cosmetics: ASEAN Cosmetic Directive-compliant PIF (Product Information File) Supplements & Veterinary
Products: Safety, efficacy, and GMP documentation as per FSQD or DVS