Singapore Regulatory Approval Process for Medical Devices

Download the Chart on the Medical Device Approval Process in SingaporeIn Singapore, medical devices are overseen by the Health Sciences Authority (HSA). Classification of devices is similar to the system in Europe, but there are some differences. Prior approval in a reference market such as Australia, Canada, Europe, Japan, or the United States may significantly reduce the review times of your devices. Download the chart for more details.

The Medical Device Approval Process in Singapore Explained

Step 1
Determine classification of your devices based on guidelines published by the Health Sciences Authority (HSA). Class A products which are non-sterile* do not have any registration requirements, and may skip directly to step 8 for Importation. For Class A sterile devices, and Classes B, C, and D, follow the steps below.

Step 2
Determine the most favorable grouping of products for systems or product families.

Step 3
Appoint a Singapore Registrant to coordinate and submit your device registration application to the HSA.

Step 4
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 United States) your device may qualify for an Abridged, Expedited, or Immediate (Class B only) submission process.

Step 5
For Class A devices (sterile), prepare Submission Dossier according to Class A data requirements found in HSA Guidance GN-15-R5, section 4. For Classes B, C and D, prepare HSA Submission Dossier using ASEAN Common Submission Dossier Template (CSDT) format. Abridged or Expedited submission: Summary data can be submitted for pre-clinical and clinical data. Complete submission: Complete all sections of HSA Submission Dossier. If applicable, include all test results and clinical data.

Step 6
For Class A sterile devices, registrant submits application to HSA using MEDICS. Pay fee. For Classes B, C and D, registrant submits your application electronically via the Medical Device Information and Communication System (MEDICS). Pay fee.

Step 7
For Class A sterile devices, HSA verifies classification and issues approval. For Classes B, C and D, HSA performs evaluation of your application. Upon approval, your Registrant completes the registration process by submitting your approved application for listing on the Singapore Medical Device Register (SMDR).

Step 8
For all devices, appoint an importer registered with the HSA to bring your device into the Singapore market.

Step 9
You may begin marketing your devices, but manufacturers of Class A Sterile, and Classes B, C, and D devices should be aware that while the registrations do not expire they do require an annual retention fee be paid, or registration will be revoked.

NOTE: This is a simplified overview of the process. The HSA may choose to audit your submission and request more documents, which will add time to your approval.

* Class A Non-sterile devices must be imported into Singapore by a licensed importer or wholesaler with nominal reporting responsibilities.

** These alternate submission routes may cut as much as 50 calendar days off the review times. Qualifications vary: Devices with approval in one reference market qualify for Abridged review. Qualifications for Expedited review vary by device class. Class B and C devices require either approval in two reference markets OR one reference market and a three-year track record without safety incidents. Expedited review of Class D devices requires prior approval in two reference markets. Immediate registration is available for Class B devices with approval in two reference markets and sold for three years without any safety issues.

Chart updated 30/09/2014.