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 |
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: 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.