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.

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

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

Fees and turnaround time

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

Process & Timeline

Step 1: Book appointment online

When: Five months before the consultation. For example, on 1 August 2017, you will be able to book appointments till 31 December 2017.

How to book: Access our online booking form on MEDICS and view scheduled appointments.

Step 2: Documents submission

When to submit: At least 30 days before the consultation. Please submit the documents early to allow us ample time to review them before your consultation.

What to submit:

Information to be provided by replying to the confirmation e-mail, or e-mail us and quote the appointment booking reference number in the subject.

Note:

  • Incomplete 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.

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.

E-mail us for more information on PMC.

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