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.
December 1, 2025
Approximately 5 minutes
Maintaining Medical Device Registration in Malaysia: The Change Notification (CN) Process
Maintaining Medical Device Registration in Malaysia: The Change Notification (CN) Process
The maintenance of a registered medical device license in Malaysia is governed by the Medical Device Authority (MDA) under the Medical Device Act 2012 (Act 737). Once a device is registered, the local license holder is responsible for ensuring that any changes to the product, its manufacturing, labeling, or supporting documentation are formally reported to the MDA through the Change Notification (CN) process. All CN submissions are made via Malaysia's medical device registration portal, MedC@st 2.0.
Categories of Change Notification (CN)
The MDA classifies changes into three distinct categories, which determine the required submission pathway and timing:
| Category | Description | Submission Requirement |
|---|---|---|
| Category 1 | Major changes that may affect the safety or performance of the device (e.g., changes to intended use, design, or sterilization method). | Requires new registration prior to implementation. |
| Category 2 | Moderate changes that require MDA review (e.g., changes to labeling, material, or non-fundamental design changes). | Requires MDA endorsement before implementation. |
| Category 3 | Minor administrative changes (e.g., software UI tweaks, non-substantive labeling changes, administrative updates). | Requires notification only; can be implemented immediately. |
Change Notification Fees and Timelines
The fees and processing timelines for Category 2 and 3 CN submissions vary based on the change type and the device's risk classification.
Change Notification Fees (RM / USD)
| Medical Device Risk Class | Category 2 Fee (RM) | Category 3 Fee (RM) |
|---|---|---|
| Class A | 50 (~$11) | 30 (~$7) |
| Class B | 500 (~$110) | 30 (~$7) |
| Class C | 1,000 (~$220) | 30 (~$7) |
| Class D | 1,500 (~$330) | 30 (~$7) |
| Device with Medicinal Product | 2,500 (~$550) | 30 (~$7) |
CN Processing Timelines
| Application Type | Timeline |
|---|---|
| Single Submission – Category 2 or 3 | 30 working days |
| Single Submission – Combination (Cat 2 + Cat 3) | 60 working days |
| Multiple Submissions – Any combination (2 and/or 3) | 60 working days |
Understanding the correct change category and submitting accurate documentation is crucial for continued compliance and seamless market access in Malaysia.
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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.
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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**.
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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.
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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
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.