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.
August 16, 2025
Approximately 5 minutes
Medical Device Grouping for Registration in Singapore: HSA's Cost-Saving Pathways
Medical Device Grouping for Registration in Singapore: HSA's Cost-Saving Pathways
The Health Sciences Authority (HSA) in Singapore allows manufacturers to simplify the registration process for multiple related products by utilizing various grouping mechanisms. This strategy is highly encouraged as it significantly reduces costs and time by submitting a single application for multiple models or components.
Core Grouping Categories
The main grouping categories are based on common product attributes, such as ownership, intended use, and manufacturing process:
- 1. Single: Represents a single medical device, which may vary only in package size or unit quantity.
- 2. System: Comprises multiple medical devices from the same product owner that are intended to be used together for a specific intended purpose. The group must be sold under a single system name. Accessories from different owners may be included if compatibility is proven.
- 3. Family: Includes medical devices from the same product owner that share a common intended purpose, risk classification, design, and manufacturing process. This grouping allows for permissible variants (e.g., changes in size, color, or minor features) and is amended via a Change Notification for new models under the same brand name.
- 4. Group: Involves two or more medical devices that are physically packaged and labelled as a single unit for the same intended purpose (e.g., a surgical kit). Requires clear labeling, proof of sterility, shelf life, and compatibility evidence.
Grouping for IVD and Specialty Devices
HSA provides specific grouping rules for In Vitro Diagnostic (IVD) devices and certain specialty products:
| Grouping Type | Device Type & Criteria | Permissible Variants/Inclusions |
|---|---|---|
| IVD Analyzers | Analyzers with a common owner, proprietary name, and risk classification based on the same methodology. | Can be grouped with corresponding IVD test kits as a System. Variants include throughput, software, sample volume, and UI. |
| IVD Test Kit | Reagents or articles from a common owner with a combined intended purpose. | Can be grouped with corresponding IVD analyzers as a System. |
| IVD Cluster | Class B IVD reagents/articles with a common owner, test methodology, and IVD Cluster category. | Lower risk accessories can be included. |
| Hearing Aids | Class B hearing aids with a common owner. | Grouped by design (BTE/ITE), sound amplification (Analog/Digital), and communication technology (Wireless/Non-wireless). |
| Dental Grouping | Class B dental devices with a common owner, where the intended purpose includes at least one descriptor from the Dental Grouping Terms (DGT). | Lower risk accessories can be included. |
Manufacturers must adhere strictly to the criteria for the chosen grouping mechanism. If a new model does not meet the shared criteria of the registered group (e.g., has a different intended purpose or a different brand name), a new product registration is required instead of a Change Notification.
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
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.