Malaysia Product Registration & Certification
Important Notes
- NPRA Mandatory Registration & Notification: All pharmaceuticals, medical devices, cosmetics, health supplements, and traditional medicines are regulated by NPRA. Drugs and some high-risk devices require registration; cosmetics and some low-risk devices require notification.
- Granular Regulation of Health Supplements & Traditional Medicines: Vitamins, herbs, etc., are clearly classified as Health Supplements or Traditional Medicines with distinct frameworks. Health Supplements are strictly governed by positive lists for ingredients, dosages, and claims.
- Local Company as Product Registration Holder: A foreign manufacturer must appoint a locally registered Malaysian company as the Product Registration Holder, assuming all legal and regulatory liabilities.
- Malay/English Bilingual Labeling Requirement: Product labels must contain information in both Malay and English, with strict adherence to NPRA guidelines.
- Halal Certification as a Market Access Threshold: For food, pharmaceuticals, and cosmetics, halal certification from JAKIM is critical, often mandatory for mainstream market and government-linked channels.
- Adoption of ASEAN Common Technical Dossier: Malaysia actively implements ASEAN harmonization schemes, accepting the ACTD for pharmaceuticals, cosmetics, and traditional medicines.
Malaysia Specific Requirements
- One of Southeast Asia’s Most Mature & Regulated Mid-to-High-End Markets: A well-developed regulatory system aligned with international standards, serving educated consumers who value quality and brand reputation.
- Global Hub & Standard-Setter for Halal Industry: Possesses the world’s most authoritative halal certification system, integrated throughout the supply chain, making it a strategic hub for the global halal market.
- Official Integration & Modernization of Traditional & Complementary Medicine: Rich traditions are regulated by NPRA to ensure standardization and safety.
- Efficiently Complementary Public & Private Healthcare Systems: Universal public coverage provides basic care, while a robust private sector drives demand for innovation and premium services.
- Key Driver of ASEAN Pharmaceutical Harmonization: Malaysia plays a leadership role in ASEAN harmonization for pharmaceuticals and traditional medicines, making its policies indicative of regional trends.
Medical Devices Registration
Regulatory Requirements
- Medical Device Registration Certificate
- Classification Management by Risk Level (Class A, B, C, D)
- Technical Documentation and Compliance Evidence
- Quality Management System Certificate
- English/Malay Labeling
- Compliance with ASEAN Medical Device Directive
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- MDA Review Submission
- Local Authorized Representative Appointment
- Registration Certificate Acquisition
Registration Timeline
7-15 months
Official Fees
MYR 5,000 - 100,000
Service Fees
$14,000 - $42,000
Regulatory System Overview
MDA
Malaysian Medical Device Authority
Responsible for medical device registration approval, quality supervision, and market regulation, operating under the Malaysian Ministry of Health as a specialized regulatory authority
NPRA
National Pharmaceutical Regulatory Agency
Responsible for registration approval and market regulation of cosmetics, pharmaceuticals, and health products
MOH
Ministry of Health Malaysia
Responsible for developing national health policies and regulatory frameworks, overseeing operations of specialized regulatory agencies
Medical Devices Registration Process
Product Classification Determination
Determine risk level according to Malaysian medical device classification rules
Technical Documentation Preparation
Prepare English technical documentation, compliance evidence, etc.
Local Authorized Representative
Appoint Authorized Representative (AB) within Malaysia
MDA Application
Submit medical device registration application to MDA
Conformity Assessment
Pass MDA conformity assessment and review
Cosmetics Registration
Regulatory Requirements
- Cosmetic Notification
- Product Information File
- Safety Assessment Report
- Good Manufacturing Practice
- English/Malay Labeling Requirements
Main Process
- Safety Assessment Completion
- Product Information File Preparation
- NPRA Notification Submission
- Labeling Review Preparation
- Market Access Completion
Registration Timeline
3-6 months
Official Fees
MYR 2,000 - 20,000
Service Fees
$7,000 - $18,000
Regulatory System Overview
MDA
Malaysian Medical Device Authority
Responsible for medical device registration approval, quality supervision, and market regulation, operating under the Malaysian Ministry of Health as a specialized regulatory authority
NPRA
National Pharmaceutical Regulatory Agency
Responsible for registration approval and market regulation of cosmetics, pharmaceuticals, and health products
MOH
Ministry of Health Malaysia
Responsible for developing national health policies and regulatory frameworks, overseeing operations of specialized regulatory agencies
Cosmetics Registration Process
Safety Assessment
Complete product safety assessment report by safety assessor
Product Information File
Prepare complete product information file
NPRA Notification
Submit cosmetic notification to National Pharmaceutical Regulatory Agency
Labeling Compliance
Ensure labeling meets bilingual requirements
Product Listing
Complete product listing in NPRA system
Health Products Registration
Regulatory Requirements
- Traditional Medicine Registration
- Product Notification or License
- Ingredient Safety and Quality Evidence
- English/Malay Labeling Requirements
- Good Manufacturing Practice
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- NPRA Registration Submission
- Labeling Review Preparation
- Market Access Completion
Registration Timeline
6-12 months
Official Fees
MYR 3,000 - 50,000
Service Fees
$9,000 - $25,000
Regulatory System Overview
MDA
Malaysian Medical Device Authority
Responsible for medical device registration approval, quality supervision, and market regulation, operating under the Malaysian Ministry of Health as a specialized regulatory authority
NPRA
National Pharmaceutical Regulatory Agency
Responsible for registration approval and market regulation of cosmetics, pharmaceuticals, and health products
MOH
Ministry of Health Malaysia
Responsible for developing national health policies and regulatory frameworks, overseeing operations of specialized regulatory agencies
Health Products Registration Process
Product Classification Determination
Determine if product falls under traditional medicine or health products
Technical Documentation Preparation
Prepare ingredient analysis, safety evidence, and other documents
NPRA Application
Submit traditional medicine registration application to NPRA
Labeling Review
Ensure labeling complies with Malaysian bilingual requirements
Product Classification
Complete product classification registration based on risk level