New HSA Rule in Singapore: Incomplete Registration Applications Will Be Rejected from 2027

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In September 2026, Singapore’s Health Sciences Authority (HSA) introduced a Premarket Submission Checklist for medical device registration applications submitted via the SHARE system.

The HSA says the checklist does not add new requirements but consolidates existing requirements from guidance documents GN-15, GN-17 and GN-18. The real change is enforcement: after the grace period, incomplete applications will be rejected outright and application fees will not be refunded.

1. Key Dates

Key dates for the HSA checklist

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2. What Does the Checklist Check?

The checklist has 13 sections, corresponding one-to-one to the folders in the SHARE system. The HSA highlights the following 6 types of common problems:

6 types of common problems highlighted by the HSA

Note that this check takes place at the completeness screening stage, separate from technical evaluation. If a section is not sufficiently detailed, it can still be improved when responding to queries later; but if an entire section is missing, the application will be rejected.

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3. GN-15 Updated at the Same Time

  • Annex 4: the labeling declaration and the adverse event/field safety corrective action (AE/FSCA) declaration are merged into a single document signed by the product owner on company letterhead. The labeling part applies to the abridged, expedited and immediate routes; the AE/FSCA part applies to all routes.
  • Annex 2 configuration list: a new implant labeling tab requires the file names for each model and accessory to be mapped to the labels, reference agency approvals, biocompatibility, sterilization, shelf life and bench test reports.
  • Software devices: the exact software version supplied in Singapore must be stated.

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4. Why It Matters

Singapore is often companies’ first stop in Southeast Asia, and HSA approval is relied on by several ASEAN countries’ reliance routes, such as the verification route of Malaysia’s MDA. If a Singapore application is rejected, you not only lose the application fee but may also delay market launch in several other markets.

In addition, many companies adapt their Singapore dossiers from documents prepared for other markets. Because the checklist checks folder by folder, omissions and misplaced documents are more easily detected.

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5. EVERBIZ’s Recommendations

  1. Use the grace period to pre-check upcoming applications against the checklist
  2. Switch to the new Annex 4 template immediately for applications submitted now
  3. Check Annex 2 against the SHARE uploads file by file; for implants, complete the new labeling tab
  4. If any folder in Section 8 is empty, attach a brief explanation rather than leaving it blank
  5. Use Section 13 only for files that genuinely cannot be classified elsewhere
  6. For software products, confirm in advance the software version supplied in Singapore

About EVERBIZ

If you need medical device registration in Singapore or Southeast Asia, contact EVERBIZ – we can help you complete a pre-review of your dossier before full enforcement in 2027.

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