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.
June 16, 2025
Approximately 5 minutes
Post-Market Surveillance and Adverse Event Reporting in Malaysia: MDA Vigilance Requirements
Post-Market Surveillance and Adverse Event Reporting in Malaysia: MDA Vigilance Requirements
Post-Market Surveillance (PMS) is a mandatory requirement for all manufacturers selling medical devices in Malaysia. This vigilance system is enforced by the Medical Device Authority (MDA) under the Medical Device Act 2012 and the Medical Device (Duties and Obligations of Establishment) Regulations 2019. Failure to comply with these requirements, which are similar to those in the ASEAN Medical Device Directive (AMDD), can result in product recall or loss of market access.
The Role of the Authorized Representative
The Malaysia Authorized Representative (AR), or license holder, whose details are listed on the product's registration certificate, holds a critical responsibility in the PMS process. The AR is the legally responsible entity for communicating with the MDA on behalf of the foreign manufacturer regarding all post-market vigilance issues, including Adverse Event (AE) reporting and Field Safety Corrective Actions (FSCAs).
Criteria for Reportable Adverse Events (AEs)
An event is considered a reportable Adverse Event (AE) only if three core criteria are met:
- An Adverse Event has occurred.
- The medical device is associated with the Adverse Event.
- The Adverse Event led to one of the following serious outcomes:
- A serious threat to public health.
- Death or serious deterioration in the state of health of a patient, user, or other person.
- No death or serious injury occurred, but the event, if it recurs, might lead to death or serious injury of a patient, user, or other person.
Mandatory Reporting Timelines
All Adverse Events must be reported to the MDA immediately and within the following specific timeframes, calculated from the moment the manufacturer or their AR becomes aware of the event:
| Event Type | Reporting Deadline |
|---|---|
| Serious threat to public health | Not later than 48 hours |
| Death or serious deterioration in state of health | Not later than 10 days |
| Recurrence might lead to death or serious injury | Not later than 30 days |
Post-Market Corrective Actions (FSCAs)
In addition to reporting, manufacturers are obligated to implement Field Safety Corrective Actions (FSCAs) if necessary. The AR is responsible for managing the communication and implementation of these corrective actions in collaboration with the MDA to ensure device safety and compliance in 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
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).