Medical Devices Regulatory Initiative
The priority review of medical devices aims to give companies the option of faster registration and market entry.
There are two routes available. Please refer to the information leaflet below for more information.
DOWNLOAD INFORMATION LEAFLET
[ File Type: PDF | Size: 1.11 MB]
More information on the Turn-around-time (TAT) and fees for the Priority Review Scheme can be found in the table below:
|Not under Priority Review
|Not under Priority Review
|PRIORITY REVIEW SCHEME|
|Route 1||Route 2|
|Class B FULL||160||120||3,500||4,100||5,300|
|Class C FULL||220||165||5,700||6,600||8,600|
|Class D FULL||310||235||11,400||13,200||17,100|
APPLYING FOR PRIORITY REVIEW SCHEME
Please opt-in for the scheme under 'Priority Review Scheme' section while submitting your product registration in MEDICS.
You may refer to the guidance documents on the submission requirements for Full Evaluation Route.
Note: For Priority Review Scheme Route 1, justification to substantiate that the device fulfill criteria 2 should be provided together with the dossier in MEDICS.
FOR MORE INFORMATION
Information Leaflet (Download)
For enquiries, email us at HSA_MD_Tech@hsa.gov.sg
The Pre-market Consultation Scheme (PMC) consists of two categories of consultation, ie Development Consultation and Pre-submission Consultation.
This scheme supports innovation and device development by enabling stakeholders to consult HSA on regulatory requirements during the early phases of device development. This may expedite device registration and speed up patients' access to safe and effective medical devices in Singapore. Depending on the product development stage, companies can engage HSA at the different stages depicted below:
More information on the respective consultation categories can be found in the table below:
|Medical Device Development Consultation||Medical Device Pre-submission Consultation|
|Scope of consultation||Regulatory pathway for medical device, including device technology, intended purpose, validation data, clinical trials, risk management||Completeness of the submission dossier and appropriateness of the supporting documents/reports|
|Target Stakeholders||Medical device developers, researchers||Stakeholders submitting medical devices for local registration|
|Stage of MD lifecycle||Any phase of medical device development||Before pre-market registration of the medical device|
|Fees||$500 per device per consultation
(up to 2 hours per consultation)
|$200 per device application per consultation
(up to 1 hour per consultation)
Schedule an appointment
Please schedule an appointment here and send us the completed form (and supporting documents) at least 30 days prior to your scheduled appointment:
- Medical Device Development Consultation Form
[Type: PDF | Size: 127KB]
- Medica Device Pre-submission Consultation Form
[Type: PDF | Size: 184KB]
To view your scheduled appointment(s), please click here.
Change or Cancel Your appointment
To change or cancel your appointment, please click here to send in your request via email.
Need help? Please refer to the application guide.
- Rescheduling of appointment can only be performed once, and is subject to availability of slot(s) at point of processing.
- All fees paid are non-refundable.