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.
March 16, 2025
Approximately 5 minutes
Medical Device Registration in Singapore: HSA's Multi-Route Reliance System
Medical Device Registration in Singapore: HSA's Multi-Route Reliance System
The Health Sciences Authority (HSA) is the regulatory body responsible for medical device registration and licensing in Singapore. Applications are submitted through the SHARE system (Singapore Health Product Access and Regulatory E-System), and approved devices are listed on the Singapore Medical Device Register (SMDR).
License Holder and Compliance Requirements
- Local Registrant: A local entity, known as the Registrant, is mandatory to submit the application and hold the license on behalf of the foreign manufacturer. This entity must also be registered with ACRA.
- Quality System: Must be documented with evidence of quality system conformity, typically an ISO 13485 certificate, or an audit report from the US FDA or Japanese PMDA.
- Post-Market: Registration is valid as long as annual listing fees (Class B: S$39, Class C: S$67, Class D: S$134) are paid and vigilance obligations are met.
- Documentation: Submissions use the ASEAN Common Submission Dossier Template (CSDT) format.
Device Classification and Registration Routes
HSA follows Global Harmonization Task Force (GHTF) guidelines, classifying devices into four risk classes (A-D). Class A devices do not require pre-market registration but must be listed annually. Registration routes for Class B, C, and D devices depend on prior approval in Reference Countries (US, EU, UK, Canada, Australia, Japan).
Registration Pathways, Timelines, and Fees (Effective July 1, 2024)
| Class | Pathway | Reference Country Approval | Review Time | Fee (S$) |
|---|---|---|---|---|
| B | Immediate | 2 | Immediate | S$1,000 |
| B | Abridged | 1 | 100 days | S$2,010 |
| B | Full | None | 160 days | S$3,900 |
| C | Immediate | 2 (SaMD only) | Immediate | S$3,340 |
| C | Expedited | 2 | 120 days | S$3,340 |
| C | Abridged | 1 | 160 days | S$3,900 |
| C | Full | None | 220 days | S$6,250 |
| D | Expedited | 2 | 180 days | S$5,930 |
| D | Abridged | 1 | 220 days | S$6,250 |
| D | Full | None | 310 days | S$12,000 |
Note: The Immediate route applies to Class B and certain Class C Software as a Medical Device (SaMD) with established profiles. The Expedited route requires two reference country approvals and includes a targeted technical review, while the Abridged route leverages the assessment of one reference country.
Related Articles
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 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.