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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.
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