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.
October 16, 2025
Approximately 5 minutes
Singapore Medical Device Labeling: HSA Compliance and AMDD Harmonization
Singapore Medical Device Labeling: HSA Compliance and AMDD Harmonization
Medical device and In Vitro Diagnostic (IVD) labeling in Singapore is governed by the Health Sciences Authority (HSA), primarily through GN-23: Guidance on Labelling for Medical Devices. The requirements are largely harmonized with the ASEAN Medical Devices Directive (AMDD) principles.
General Labeling Requirements
- Language: All product labeling, including the main label and Instructions for Use (IFU), must be in English.
- Principle: The label must be of a reasonable size for the device type and contain sufficient information for the user to safely identify and use the product.
- Instructions for Use (IFU): IFUs are generally required, but may be omitted for certain low-risk devices. Additional information that cannot fit on the device label must be included in the IFU or inside the packaging.
Required Label Content for All Devices (MD and IVD)
The label for both general medical devices and IVDs must include the following key pieces of information:
- Product Owner Details: Name, address, and telephone number of the product owner/manufacturer.
- Trade/Brand Name: The commercial name of the device.
- Identification Details: Information clearly identifying the specific device.
- Batch/Lot Number: For traceability purposes.
- Expiration Date: If applicable to the device or its components.
- Sterilization Status: Indication of whether the product is Sterile or Non-Sterile.
- Warnings/Precautions: Warnings regarding potential malfunctions, precautions, and proper disposal methods.
- Specific Requirements: Any additional requirements based on device characteristics (e.g., single-use only, implantable device, radiation-emitting, custom-made).
Specific Requirements for IVD Devices
In addition to the general requirements, IVD products must adhere to extra mandatory information related to their diagnostic function, including:
- Intended Purposes: Specific details on the analyte, whether the test is qualitative or quantitative, and the clinical application.
- Test Principle: The scientific or methodological basis of the assay.
- Assay Procedure: Clear instructions, including calculation steps and interpretation guidelines.
- Performance Characteristics: Data on the test's performance, such as sensitivity and specificity.
- Specimen Type: The type of sample required (e.g., blood, urine, tissue).
- Collection Conditions: Instructions on the conditions for specimen collection.
- Reference Intervals: The established normal ranges or cut-off values.
- Reagent Description and Limitations: A description of the reagents used and any known limitations of the test or study design.
Compliance with these precise labeling rules is part of the HSA's product review process, ensuring market safety.
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 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.