Ministry of Health

Ministry of Health of Singapore

Regulatory Authority

Health Sciences Authority (HSA)

Medical Device Regulation

Health Products (Medical Devices) Regulations 2010

GN-15 Guidance on Medical Device Product Registration (Jan 2022)

Official Language

English, Mandarin, Malay and Tamil

Classification

Class A, B, C, and D

Registration Process

• 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.

Documents Required

• Application Form
• Registration Dossier
• Declaration of Conformity to the Essential Principles
• Payment Receipt
• QMS certificates
• Clinical Studies Report
• Other Regulatory Approvals
• Postmarket vigilance plans

Applicable QMS

ISO 13485

Registration Timeline

• Class A – 1 Month
• Class B – 2-6 months
• Class C – 4-8 months
• Class D – 6-12 months

Authorized Representative

A license holder or Registrant

License Validity

Unlimited validity

Special Notes

Documentation and labelling must be provided in English.