Singapore Medical Device Grouping

Singapore’s HSA allows manufacturers to group their products in a variety of ways to allow for a simplification of the application process, which in turn, is more cost effective and time saving for the manufacturer. To be grouped together, the products will need to adhere to the specific rules to belong to certain categories. The different grouping categories are as follows:

1. Single
2. System
3. Family
4. Group
5. IVD Analyzers
6. IVD Test Kit
7. IVD Cluster
8. Hearing Aids
9. Dental Grouping Terms (DGT)
10. Immunohistochemistry (IHC) IVD Reagents
11. Fluorescence in situ hybridization (FISH) probes IVD
12. In-Vitro Fertilization (IVF) Media

Applications can be submitted as one of the following:

Single: A single medical device that can range in package sizes and/or number of units.

System: Medical devices with a common product owner that are intended to be used in combination for an intended purpose. Required to be sold under a single system name. Other medical devices and/or accessories from a different product owner may be included if compatible.

Family: Medical devices with a common product owner, intended purpose, risk classification, design, and manufacturing process. Permissible variants for both general and specific products apply. Grouping can be amended with a Change Notification if new models have the same brand name as an already registered medical device (same criteria must be met). If there is a different brand name, a new product registration must be submitted.

Group: Two or more medical devices grouped and labelled as a single packaged unit for the same intended purpose. Requirements include information about sterility, shelf life, compatibility evidence, quality management systems (QMS), and clear labeling of the intended purpose.

IVD Analyzers: Analyzers with a common product owner, propriety name, and risk classification determined by the same methodology can be grouped as a Family. The following permissible variants apply:

• Throughput
• User Interface (UI) variation
• Printing function
• Wireless capability
• Software
• Sample volume
• Onboard stability
• Calibration frequency

IVD analyzers can also be grouped with their corresponding IVD test kits as a System. Grouping can also include lower risk/same risk accessories and can be amended with a Change Notification if new models are to be added over time (same criteria must be met).

IVD Test Kit: Reagents or articles with a common product owner and a combined intended purpose. Can be sold as a single test kit or used with an IVD test kit. IVD test kits can also be grouped with their corresponding IVD analyzers as a System.

IVD Cluster: Class B IVD reagents or articles with a common product owner, test methodology, and IVD Cluster category.

Singapore’s HSA also has additional guidance for specific product type exceptions.

Hearing Aids

Class B hearing aids with a common product owner can be grouped by the following:

• Design: Behind the ear (BTE) or in the ear (ITE)
• Sound amplification: Analog or Digital
• Communication technology: Wireless or Non-wireless

Hearing Aids grouping can also include lower risk/same risk accessories and can be amended with a Change Notification if new models are to be added over time (same criteria must be met).

Dental Grouping Terms (DGT)

Class B dental devices with a common product owner. The intended purpose has at least one descriptor found in the Dental Grouping Terms. The DGT can also include lower risk accessories and can be amended with a Change Notification if new models are to be added over time (same criteria must be met).

Immunohistochemistry (IHC) IVD Reagents

Either all Class B or all Class C reagents and accessories with a common product owner. Risk is based on IHC methodology. Excludes reagents meant to be used with flow cytometry. Grouping can be amended with a Change Notification if new models are to be added over time (same criteria must be met).

Fluorescence in situ hybridization (FISH) probes IVD

Either all Class B or all Class C reagents and accessories with a common product owner. Risk is based on FISH methodology. FISH probes grouping can be amended with a Change Notification if new models are to be added over time (same criteria must be met).

In-Vitro Fertilization (IVF) Media

IVF Media with a common product owner that are intended to be used in combination for an IVF procedure. IVF media device grouping can be amended with a Change Notification if new models are to be added over time (same criteria must be met).

The HSA has an online tool to help determine the best group for your product.

Contact Asia Actual for more information about Singapore grouping requirements.