Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
EPSI GLOBAL PTE. LTD.
Singapore (HQ), Kuala Lumpur, Malaysia, Jakarta, Indonesia, Bangkok, Thailand, Hanoi, Vietnam, Manila, Philippines, Shanghai, China
We provide end-to-end regulatory solutions covering all classes of medical devices and IVDs in major APAC markets, especially the ASEAN region (Singapore, Malaysia, Indonesia, Thailand, Vietnam, Philippines) and major Northeast Asian markets (China, Korea, Japan). Services include classification, registration, local authorized representation, quality management system (QMS) implementation/auditing (ISO 13485/local GMP), and post-market surveillance. Their local presence minimizes market entry risks and time-to-market.
August 16, 2025
Approximately 5 minutes
Mandatory Medical Device Labeling Requirements in Malaysia: Language, Content, and MDA Guidance
Mandatory Medical Device Labeling Requirements in Malaysia: Language, Content, and MDA Guidance
Medical device labeling in Malaysia is strictly regulated by the Medical Device Authority (MDA) through its official Guidance Document. Adherence to these requirements is mandatory before a product can be imported and placed on the market. The labeling must be appropriate for the device, containing enough information for the user to safely identify and use the product.
Language Requirements
- Standard Requirement: All product labels must be in English.
- Home Use Products: Devices intended for home use require the Instructions For Use (IFU) and related materials to be available in both English and Bahasa Malaysia.
- IFU Necessity: Paper versions of all labeling must accompany the product. Note that low and moderate-risk devices may not require an IFU.
General Mandatory Label Content
The following information, at minimum, must be included on the label or packaging:
- Identification: Name, model, batch, serial number, and date of manufacturing/expiry.
- Registration Status: The Malaysian medical device registration number. The MDA encourages the use of QR codes for the registration number.
- Responsible Parties:
- Manufacturer Name, Address, Tel. No., and Web address.
- Name and Address of the Authorized Representative (AR).
- Product License Number.
- Product Details: Description, intended use, undesirable side effects, limitations, warnings, and precautions.
- Post-Market Information: Post-market servicing, decommissioning, and disposal information.
Note: Labels must not claim promotion or endorsement by the Ministry of Health (MoH) or the MDA.
Special Labeling Cases
- IVD Specific Requirements: In Vitro Diagnostic (IVD) products must adhere to general guidelines plus additional, specific requirements, including intended purposes (analyte type, qualitative vs. quantitative), test principle, assay procedure, traceability information, reference intervals, and performance characteristics.
- Export-Only Exemption: Medical devices intended solely for export are exempted from the Malaysian labeling requirements, provided the device is:
- Labeled as “export only.”
- Compliant with the labeling requirements of the destination country.
- Not intended to be placed on the Malaysian market.
Related Articles
Approximately 5 minutes
Medical Device Registration in Malaysia: MDA Requirements, ASEAN Alignment, and Reliance Pathways
Medical device registration in Malaysia is mandatory, managed by the **Medical Device Authority (MDA)**, and requires a local **Malaysia Authorized Holder (MAH)** to submit via the **MEDCAST** system. Classification follows **AMDD/GHTF** (Classes A-D), with faster review times (6-8 weeks for Class A; 3-6 months for others) and provisional registration granted under the **Fast Track System** based on **Reference Country** approvals.
Approximately 5 minutes
IVD Product Registration in Malaysia: MDA Oversight, Fast Track, and ISO 13485 Mandate
In Vitro Diagnostic (IVD) product registration in Malaysia is managed by the **Medical Device Authority (MDA)** and requires a local **Authorized Representative** to submit via the **MEDCAST** system. **Class A** devices (non-measuring, non-sterile) are exempt. Other classes are eligible for a **Fast Track Provisional Registration** (up to 5 years) based on **Reference Country** approval, while all must document quality compliance with **ISO 13485**.
Approximately 5 minutes
Medical Device Classification in Malaysia: Risk-Based System and AMDD Alignment
Malaysia’s Medical Device Authority (MDA) classifies devices into risk categories **A, B, C, and D** (low to high), plus a separate **Combination Device** class, based on the **ASEAN Medical Devices Directive (AMDD)**. Classification is determined by factors like intended use, duration of contact, invasiveness, and local vs. systemic effects, with more documentation required as risk increases.
Approximately 5 minutes
Medical Device Grouping in Malaysia: Streamlining Registration via the ASEAN MDD Framework
The Malaysian Medical Device Authority (MDA) allows manufacturers to streamline registration through **Grouping**, which is harmonized with the **ASEAN MDD**. All groupings (Single, Family, System, Set, IVD Test Kit, IVD Cluster) must adhere to three core rules: **one generic proprietary name, one manufacturer, and one common intended purpose**. The Family grouping allows for multiple 'Permissible Variants' like size, color, and certain design differences under a single application.
Approximately 5 minutes
Maintaining Medical Device Registration in Malaysia: The Change Notification (CN) Process
In Malaysia, maintaining a medical device license requires the license holder to report all changes via the **Change Notification (CN)** process through the **MedC@st 2.0** portal. Changes are categorized into three types: **Category 1** (requires new registration for major changes), **Category 2** (requires MDA endorsement for moderate changes), and **Category 3** (minor administrative changes that can be implemented immediately with notification).
Approximately 5 minutes
Post-Market Surveillance and Adverse Event Reporting in Malaysia: MDA Vigilance Requirements
The MDA mandates Post-Market Surveillance (PMS) for medical devices in Malaysia, requiring manufacturers to report Adverse Events (AEs) within strict timelines: **48 hours** for public health threats, **10 days** for death/serious deterioration, and **30 days** for potential serious injury recurrence. The **Malaysia Authorized Representative** is responsible for communicating all post-market vigilance to the MDA.