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 Medical Device License Maintenance: Annual Fees and Change Notifications
Singapore Medical Device License Maintenance: Annual Fees and Change Notifications
For manufacturers to maintain market access and comply with the Health Sciences Authority (HSA) regulations in Singapore, they must adhere to specific requirements for license maintenance, which includes annual fees and mandatory reporting of product or administrative changes.
Annual Retention Fees
Registered medical device listings on the Singapore Medical Device Register (SMDR) do not expire as long as the annual retention fee is paid and the product remains the same.
| Device Class | Annual Listing Fee (SG$) |
|---|---|
| Class B | S$39 |
| Class C | S$67 |
| Class D | S$134 |
HSA Change Notifications (Registration Modification)
Any changes to the product from the time of original registration must be approved by the HSA via a Registration Modification (Change Notification) prior to importing the modified product. HSA's guidance for these changes is detailed in GN-21.
The four types of changes requiring approval are:
- Administrative Changes: Affecting administrative documents and information submitted during registration (e.g., changes to the Registrant's address).
- Review Changes (Class B): Changes affecting the safety, quality, or efficacy of Class B devices, or the addition of new models/changes to indications for use.
- Technical Changes (Class C & D): Changes affecting the safety, quality, or efficacy of Class C and D medical devices.
- Notification Changes: All other changes, including removing device particulars publicly published on the SMDR listing. These can often be bundled together in one application.
Timelines and Fees for Change Notifications
| Device Classification | Change Type | Review Time | Fee (SG$) |
|---|---|---|---|
| Class B | Administrative | 30 days | S$560 |
| Class B | Review | 45 days | S$560 |
| Class C | Administrative | 30 days | S$560 |
| Class C | Technical | 75 days | S$1,890 |
| Class D | Administrative | 30 days | S$560 |
| Class D | Technical | 90 days | S$3,120 |
Note: Changes to Class D devices that contain a registrable drug do not have specified timelines and are estimated on a case-by-case basis by the HSA.
Changes Requiring a New Registration
Certain substantial changes do not qualify for a Change Notification and necessitate the submission of a completely new product registration application:
- Change in Risk Classification of the device.
- Change in Intended Use of the device.
- Change of the Registrable Drug where it plays a secondary role in a combination device.
- Addition of a Model that does not fulfill the Grouping Criteria outlined in the HSA Guidance Notes.
- Addition of Medical Devices with different proprietary names that are not permitted to be grouped under the existing listing.
The Registrant (License Holder) is responsible for ensuring all modifications are properly assessed and approved by the HSA before the changed product is imported. Failure to do so may result in the suspension or cancellation of the device listing.
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 Post-Market Surveillance: Mandatory Adverse Event Reporting to HSA
Singapore's HSA mandates post-market surveillance for all medical devices under the Health Products Act. The local **Registrant/Distributor** is primarily responsible for reporting Adverse Events (AEs) occurring in Singapore, which must be reported within **48 hours (public health threat)** to **30 days (potential serious injury upon recurrence)**, depending on the severity. Manufacturers are responsible for providing all necessary information, with the clock starting immediately upon notification of the event.
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.