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.
November 16, 2025
Approximately 5 minutes
IVD Product Registration in Malaysia: MDA Oversight, Fast Track, and ISO 13485 Mandate
IVD Product Registration in Malaysia: MDA Oversight, Fast Track, and ISO 13485 Mandate
In Vitro Diagnostic (IVD) product registration in Malaysia is overseen by the Medical Device Authority (MDA), which is part of the Ministry of Health Malaysia (MoHM). As stipulated under the Medical Device Act 2012, registration is mandatory for most IVD products before they can be imported and placed on the market.
Key Requirements and Submission
- Regulating Authority: The Medical Device Authority (MDA).
- License Holder: Applications must be submitted via the online MEDCAST system by a licensed, local entity, acting as the Malaysia Authorized Representative.
- Exemption: Class A IVD devices that are non-measuring and non-sterile are exempt from the registration requirement.
Classification and Fees
IVD device classification follows the risk-based model (A, B, C, D) defined in the Medical Device Act, with registration costs varying by class:
| Device Classification | Application Fee (MR) | Processing Fee (MR) |
|---|---|---|
| Class A | MR100 | n/a |
| Class B | MR250 | MR1,000 |
| Class C | MR500 | MR2,000 |
| Class D | MR750 | MR3,000 |
| Combination Device | MR750 | MR5,000 |
Note: Official application processing times are not yet publicly available.
Registration Pathways and Documentation
Malaysia utilizes a system of reliance on foreign approvals to expedite market access:
- Fast Track Provisional Registration: IVD devices (Class B, C, D) that have been approved in a Reference Country (e.g., US, EU, Japan) are eligible for this fast track. This allows the MDA to issue a provisional registration, effectively granting the manufacturer up to 5 years to submit the full documentation, including the locally issued Certificate of Conformity.
- Required Documentation: All submissions must include a Certificate of Conformity from a local, authorized Conformity Assessment Body (CAB).
Quality System Compliance
Quality system conformity assessment documentation is a mandatory part of the IVD registration application:
- Manufacturers must submit proof of quality compliance, typically in the form of a valid ISO 13485 certificate.
- In lieu of ISO 13485, the MDA may also accept an audit report from the US FDA (e.g., Establishment Inspection Report) or the Japanese PMDA.
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
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.