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January 27, 2026
Approximately 5 minutes
Singapore HSA Grouping Framework for IVF Media
Singapore HSA Grouping Framework for IVF Media
1. Purpose of Grouping
HSA permits grouping of IVF media products to streamline the registration process for similar formulations from the same manufacturer. This allows multiple media products with comparable composition and intended use to be submitted in a single application, reducing redundancy while ensuring each proprietary name is distinctly listed on the Singapore Medical Device Register (SMDR). https://www.hsa.gov.sg/medical-devices/registration/grouping/ivf-media
2. Eligibility Criteria
IVF media products can be grouped if they meet all of the following conditions:
- Same product owner / manufacturer
- Same risk classification (typically Class D for IVF media)
- Same intended purpose (supporting human embryo culture, gamete handling, or related assisted reproduction procedures)
- Similar formulation principles (e.g., same base components, buffering system, protein source, and supplementation strategy)
- Comparable safety and performance profile based on risk assessment https://www.hsa.gov.sg/medical-devices/registration/grouping/ivf-media
3. Allowed Variations within a Group
Permitted differences include:
- Minor variations in concentrations of non-critical components (e.g., amino acids, vitamins) that do not alter the overall performance
- Different proprietary or brand names
- Variations in packaging formats or volumes (provided the product-contacting materials remain equivalent)
- Minor changes in labeling or instructions that do not affect clinical use
Significant changes (e.g., different protein sources, addition/removal of key supplements, or altered embryo culture outcomes) disqualify grouping and require separate registration. https://www.hsa.gov.sg/medical-devices/registration/grouping/ivf-media
4. Documentation Requirements
Grouped applications must include:
- A grouping rationale explaining similarities across products and justifying inclusion of variants
- A comparison table detailing differences in composition, packaging, or labeling while demonstrating equivalence in safety and efficacy
- Representative technical documentation covering the common platform (e.g., base formulation, manufacturing process)
- Individual labeling and instructions for use for each proprietary name variant https://www.hsa.gov.sg/medical-devices/registration/grouping/ivf-media
5. Registration and Listing Process
- The grouped IVF media are registered under one application
- Upon approval, each product with a unique proprietary name is listed separately on the SMDR
- All variants share the same registration number but are identified individually by name https://www.hsa.gov.sg/medical-devices/registration/grouping/ivf-media
6. Post-Registration Changes
- Adding new variants with the same proprietary name that meet grouping criteria: submit a Change Notification
- Introducing IVF media with new proprietary names: requires a new product registration application
- Major formulation or performance changes: may necessitate re-registration or separate application https://www.hsa.gov.sg/medical-devices/registration/grouping/ivf-media
7. Benefits and Practical Considerations
Grouping facilitates efficient registration of IVF media families with minor variations, lowering administrative and cost burdens for manufacturers. Manufacturers should consult HSA early for complex formulations or borderline cases to confirm grouping eligibility and avoid delays. https://www.hsa.gov.sg/medical-devices/registration/grouping/ivf-media
This framework supports timely market access for IVF media in Singapore while maintaining strict standards for safety and performance in assisted reproduction. https://www.hsa.gov.sg/medical-devices/registration/grouping/ivf-media
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