Medical Device Registration in
Ministry of Health
Ministry of Health of Singapore
Health Sciences Authority (HSA)
Medical Device Regulation
Health Products (Medical Devices) Regulations 2010
GN-15 Guidance on Medical Device Product Registration (Jan 2022)
English, Mandarin, Malay and Tamil
Class A, B, C, and D
- Determine the device classification
- Appoint an Authorized Representative
- Registration is not required for Class A devices. All Class A devices must be listed in the HSA’s Class A Medical Device Register by the local manufacturer or local importer.
- For classes B, C and D, if your device has been approved for sale in one or more reference markets (Australia, Canada, Europe, Japan or the USA), it qualifies for an Immediate, Expedited, or Abridged submission process
- Prepare Submission Dossier using ASEAN Common Submission Dossier Template (CSDT) format or IMDRF Table of Contents (ToC) format. Provide proof of compliance with the reference market’s QMS requirements. Abridged/Expedited submission: Summary data can be submitted for pre-clinical and clinical data. Additional details for Classes B, C, and D may be found in HSA Guidance GN-15.
- Registrant submits application electronically via the Medical Device Information and Communication System (MEDICS). Pay fee.
- Appoint a registered importer to bring your device into Singapore.
- HSA verifies classification, performs a detailed evaluation of your application, grants approval and publishes in the Singapore Medical Device Register (SMDR).
- The manufacturer may now begin marketing your device in Singapore.
- Application Form
- Registration Dossier
- Declaration of Conformity to the Essential Principles
- Payment Receipt
- QMS certificates
- Clinical Studies Report
- Other Regulatory Approvals
- Postmarket vigilance plans
- Class A – 1 Month
- Class B – 2-6 months
- Class C – 4-8 months
- Class D – 6-12 months
A license holder or Registrant
Documentation and labelling must be provided in English.