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.
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.
CMIC Holdings Co., Ltd.
Tokyo, Japan (HQ), Osaka, Japan, Beijing, China, Seoul, South Korea, Taipei, Taiwan, Singapore, New York, USA, London, UK, Frankfurt, Germany, Sydney, Australia
We operate globally, specializing in accelerating the development, manufacturing, and commercialization of drugs and medical devices. Their expertise spans Phase I to IV clinical trials, regulatory affairs, quality assurance, and manufacturing, with a strong focus on the Japanese and Asian markets. Key services include clinical operations (CRO), manufacturing (CDMO/CMO), site management (SMO), and comprehensive health analysis and solutions.
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
Singapore Post-Market Surveillance: Mandatory Adverse Event Reporting to HSA
Singapore Post-Market Surveillance: Mandatory Adverse Event Reporting to HSA
Post-market surveillance (PMS) and vigilance reporting in Singapore are mandatory for all medical devices and are governed by the Health Products Act and the Health Products (Medical Devices) Regulation 2010. The system, managed by the Health Sciences Authority (HSA), focuses on prompt and thorough reporting of Adverse Events (AEs).
Adverse Event (AE) Reporting Requirements
The local Registrant or Distributor is primarily responsible for submitting AE reports to the HSA. However, the manufacturer is responsible for ensuring all necessary data is available, as the reporting timeline starts as soon as any personnel (manufacturer or distributor) are notified of the event. HSA's guidance for AE reporting is found in GN-05-R2.1.
An event is considered a reportable Adverse Event if all three criteria are met:
- An Adverse Event has occurred.
- The medical device is demonstrably associated with the AE.
- The AE led to one of the following serious outcomes:
- Death of a patient, user, or other person.
- Serious deterioration in the state of health of a patient, user, or other person.
- A serious threat to public health.
- No death or serious injury, but the event, if it recurs, might lead to death or serious injury.
Note: HSA generally does not require reports for AEs occurring outside of Singapore unless the event's recurrence could lead to death or serious injury.
Mandatory Reporting Timelines
The urgency of reporting an AE to the HSA is dictated by the severity of the outcome, with all reports expected to be submitted immediately upon confirmation.
| Severity of Adverse Event | Mandatory Reporting Deadline |
|---|---|
| Serious Threat to Public Health (e.g., contamination, widespread failure) | Not later than 48 hours from confirmation |
| Led to Death or Serious Deterioration in Health | Not later than 10 days from confirmation |
| Potential Serious Deterioration upon Recurrence (No death/serious injury yet, but recurrence might) | Not later than 30 days from confirmation |
A final, comprehensive report for the event should typically be submitted within 30 days of the initial report, regardless of the initial submission timeline.
Field Safety Corrective Actions (FSCA)
If a manufacturer initiates a Field Safety Corrective Action (e.g., product recall, modification, or notice) anywhere in the world due to a medical device safety issue, they must notify the HSA about this action, even if the device has not experienced the reported AE in Singapore. This ensures the HSA can assess the risk to Singaporean users.
Effective PMS is critical for maintaining the device registration and the Dealer's License in Singapore.
Related Articles
Approximately 5 minutes
Medical Device Registration in Singapore: HSA's Multi-Route Reliance System
Singapore's HSA regulates medical device registration using a risk-based classification (Class A-D) and four reliance pathways: Immediate, Expedited, Abridged, and Full. Registration requires a local **Registrant** and is facilitated by approvals in **Reference Countries** to streamline the process and reduce review timelines from 310 days (Full) to immediate.
Approximately 5 minutes
IVD Device Registration in Singapore: HSA's Risk-Based Reliance Pathways
The HSA regulates IVD devices in Singapore based on GHTF risk classification (A-D). Registration leverages approvals from **Reference Countries** to determine the pathway (Immediate, Expedited, Abridged, or Full), thereby significantly reducing review times, which can range from **0 working days** (Immediate) to **310 working days** (Full for Class D). All applications must be submitted by a local **Registrant**.
Approximately 5 minutes
Medical Device Classification in Singapore: A Risk-Based GHTF Approach
Singapore’s Health Sciences Authority (HSA) classifies medical devices (MD) and IVDs into four risk classes (**Class A, B, C, D**) following **GHTF guidance**. Risk is determined by factors like intended use, invasiveness, and duration of contact. Higher-risk devices require more stringent registration. Special rules apply to **Software as a Medical Device (SaMD)** and devices for telehealth or aesthetic purposes.
Approximately 5 minutes
Medical Device Grouping for Registration in Singapore: HSA's Cost-Saving Pathways
Singapore's HSA permits medical device and IVD manufacturers to consolidate multiple products into a single registration application through various grouping mechanisms, such as **Family**, **System**, and **Group**. This approach reduces costs and processing time, provided the devices share criteria like intended purpose, risk class, and design. Specific rules exist for IVD analyzers, test kits, and dental devices.
Approximately 5 minutes
Singapore's GDPMDS: The Mandatory QMS for Medical Device Distribution
The **Good Distribution Practice for Medical Devices (GDPMDS)**, formalized under SS 620:2016, is a mandatory Quality Management System (QMS) standard in Singapore. It is enforced by the **HSA** and required for all companies involved in the **importation and wholesale** of medical devices and IVDs. GDPMDS certification is the foundational step for obtaining a Medical Device Dealer's License.
Approximately 5 minutes
Singapore Medical Device Labeling: HSA Compliance and AMDD Harmonization
Singapore's HSA mandates medical device and IVD labeling be in **English** and align with the **ASEAN Medical Devices Directive (AMDD)**, detailed in **GN-23**. The label must contain information for safe identification and use, including product owner details, batch/lot number, and sterilization status. IVDs have additional requirements covering intended purpose, performance characteristics, and specimen type.
Approximately 5 minutes
Singapore Medical Device License Maintenance: Annual Fees and Change Notifications
Maintaining a medical device registration in Singapore requires payment of an **Annual Retention Fee** and mandatory reporting of all changes via **Registration Modification (Change Notifications)** to the HSA. Changes are categorized as Administrative, Review, or Technical, with processing times ranging from **30 to 90 days** depending on the device class and the nature of the change. Major changes, such as a change in intended use, require a **new product registration**.
Approximately 5 minutes
Singapore's SaMD Regulation: Cybersecurity, AI, and Lifecycle Compliance
The HSA regulates all Software as a Medical Device (SaMD), including AI and mobile apps, under a lifecycle approach. Registration requires adhering to the IMDRF risk classification and demonstrating a strong **cybersecurity strategy** (Secure-by-Design, threat modeling). SaMD labeling must include precise **versioning**, and changes, particularly to algorithms or AI features, are subject to rigorous **Change Notification** review.