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Health Sciences Authority

Consultation schemes

You can seek innovation support during a medical device's development or pre-submission phase to speed up a patient's safe and effective access to it.

Last updated 23 April 2026

What is it

Under the Pre-market Consultation (PMC) Scheme, you can consult us on regulatory requirements during the medical device development, or seek feedback on your device dossier before submission to us. This may expedite device registration and facilitate early access of medical devices.

The PMC Scheme will also help you adhere to regulatory requirements in Singapore, regardless of where your product is being developed, and can be classified into the following two categories below:

1. Development Consultation

This is a channel for medical device developers and researchers to seek regulatory requirements advice during a medical device's development phase.

The Development Consultation phase includes the following stages in the medical device life cycle:

  • Concept feasibility

  • Invention and prototyping

  • Design validation (pre-clinical)

  • Clinical consultation

2. Pre-submission Consultation

A channel for stakeholders to seek feedback on their device dossier before registration application submission to us. This is to ensure supporting documents are complete and appropriate.

Consultations at a glance

Consultations at a glance

Consultation Category

Development Consultation

Pre-submission Consultation

Scope

To seek regulatory advice during development, which may include:

  • Device claims

  • Safety/performance studies, e.g. sterility and biocompatibility

  • Risk management

  • Clinical trials

To seek feedback on how complete and appropriate the device dossier is

Target stakeholders

Medical device developers, researchers

Stakeholders submitting medical devices for local registration

Stage of Medical Device Lifecycle

During device development ideation

Before registration application submission

Number of products to be discussed (per consultation)

A single device or a group of devices to be used together as a system

Limited to one single product registration application

Duration (per consultation)

Up to 2 hours

Up to 1 hour

The consultations under PMC scheme are applicable for products that are “medical devices”. Since Class A medical devices are not subject to evaluation and registration, pre-submission consultation would not be applicable for these medical devices. Stakeholders may apply for development consultation for Class A medical devices. Please ensure that your product is a medical device and that you have chosen the appropriate consultation scheme when applying. There will be no refund for all fees paid. 

Fees and turnaround time

Refer to medical device fees and turnaround time for more information.

Process & Timeline

Step 1: Book appointment online

When: 30 days before and up to five months in advance. For example, on 1 August 2025, you will be able to book appointments from 1 September 2025 till 31 December 2025.

How to book: Access our online booking form on SHARE.

Step 2: Documents submission

When to submit: At the point of appointment booking. Note that all documents are required to be submitted at least 30 days before the appointment date. 

What to submit:

For Device Development: Please upload the supporting information/ documents on SHARE in relation to the questions to be discussed. 

For Pre-Submission Consultation: Please upload the documents compiled for pre-market product registration in SHARE. Documentary requirements for pre-market product registration can be found in the following guidance documents: 

  • GN-15: Guidance on Medical Device Product Registration

  • GN-17: Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT

  • GN-18: Guidance on Preparation of a Product Registration Submission for In-Vitro Diagnostic (IVD) Medical Devices using the ASEAN CSDT

The guidance documents are available at: https://www.hsa.gov.sg/medical-devices/tools-and-resources/guidance-documents/

Step 3: Request for information

We will review the documents submitted and may ask for more information via e-mail before the appointment. If you fail to provide the information requested by the required time, your appointment may be rescheduled or cancelled.

Note:

  • Incomplete or insufficient information may result in the appointment being rescheduled or cancelled. Fees paid are not refundable.

  • You may change or cancel the appointment by e-mail.

  • Only one rescheduling is allowed per booking reference, which is subject to availability at the point of processing.

  • Our advice will be based on your questions/issues indicated in the consultation application and product information provided prior to the consultation.   Any new information or data presented during the consultation and related issues may not be addressed as the new data and its implication on device validation or development pathway will need to be assessed thoroughly.

  • If changes are made to the development plans or new device data/information are generated after the meeting, please note that the advice provided during the consultation may no longer be applicable.

  • A maximum of 5 attendees is recommended for the consultation. 

  • The consultation is not a scientific evaluation of the medical device and does not guarantee approval or clearance for pre-market registration. 

E-mail us for more information on PMC.