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.
October 16, 2025
Approximately 5 minutes
Medical Device Registration in Malaysia: MDA Requirements, ASEAN Alignment, and Reliance Pathways
Medical Device Registration in Malaysia: MDA Requirements and Pathways
Medical device regulations in Malaysia are governed by the Medical Device Authority (MDA) under the Ministry of Health Malaysia (MoHM), as outlined in the Medical Device Act 2012. Registration with the MDA is mandatory before any medical device can be imported or placed on the market.
Government Authority and License Holder
- Regulator: The Medical Device Authority (MDA) is the government body responsible for administering the regulations.
- License Holder: Registration applications must be submitted via the online MEDCAST system by a licensed, local entity known as the Malaysia Authorized Holder (MAH). The MAH acts as the license holder on behalf of the foreign manufacturer.
- License Transfer: Licenses are transferable between Authorized Representatives (ARs) via an application on the MEDCAST portal, requiring a Termination Letter and a Letter of Authorization from the new AR.
Classification and Registration Routes
Malaysia's classification system aligns closely with the ASEAN Medical Devices Directive (AMDD) and GHTF guidelines, categorizing devices into four risk classes (A, B, C, and D), plus a fifth category for combination devices.
| Device Class | CAB Fees (MR/USD) | MOH Fees (MR/USD) | Review Times |
|---|---|---|---|
| Class A | n/a | MR100 / $21 | 6 to 8 weeks |
| Class B | MR1,300 / $273 | MR1,250 / $263 | 3 to 6 months |
| Class C | MR1,300 / $273 | MR2,500 / $525 | 3 to 6 months |
| Class D | MR1,300 / $273 | MR3,750 / $788 | 3 to 6 months |
Reliance and Provisional Registration
The MDA employs pathways that leverage approvals from other major regulatory jurisdictions:
- Reference Countries: Devices approved in one of the following reference countries are eligible for faster registration pathways: Australia, Canada, European Union, Japan, United States, Singapore, or Thailand.
- Fast Track System (Provisional Registration): For devices with reference country approval, the MDA may issue a provisional registration. This allows the device up to 5 years to submit the required Certificate of Conformity from a local, authorized Conformity Assessment Body (CAB).
- Regional Pilot Programs: Malaysia is actively participating in regional pilots, such as the Singapore–Malaysia Regulatory Reliance Pilot, aimed at accelerating access for eligible Class B, C, and D devices by relying on approvals from partner regulatory agencies.
Required Documentation
A key component of the registration application is the Certificate of Conformity from a local CAB, which verifies that the manufacturer meets the regulatory requirements. The entire submission process for Class B, C, and D devices involves the local CAB for assessment prior to submission to the MDA.
Related Articles
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
Mandatory Medical Device Labeling Requirements in Malaysia: Language, Content, and MDA Guidance
Medical device labeling in Malaysia is regulated by the **MDA's Guidance Document** and must contain key information like the **Malaysian registration number** and the **Authorized Representative's** details. All labels must be in **English**, and products for home use require instructions in both **English and Bahasa Malaysia**. Manufacturers are encouraged to use **QR codes** for registration numbers. Devices for export only are exempted if marked as 'export only'.
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.