Health Sciences Authority - Guideline on Application for Import of Clinical Trial Test Materials (CTM for Medical Devices)

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Guideline on Application for Import of Clinical Trial Test Materials (CTM for Medical Devices)

Application Guide

Import of unregistered medical devices into Singapore for use in clinical trials requires the approval of the Health Sciences Authority. Application for approval of the import of unregistered medical devices for both investigational and non-investigational purpose in a clinical trial is to be made using the Application Form for CTM (Medical Devices):

Application Form for CTM (Medical Devices) - Jan 2012

File Size: (432 Kb)

The CTM (Medical Devices) form is to be completed and submitted by the sponsor to:

Clinical Trials Branch (CTM-MD)
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way #11-01 Helios
Singapore 138667

One CTM form is to be submitted for each clinical trial. That is, it is protocol specific.

The trial title, protocol number, principal investigator(s) and trial institution(s) are to be stated in Section A.

The particulars of the local sponsor are to be stated in Section B, which is to be signed by the person (local sponsor applicant) responsible for the CTM (Medical Devices) Application.

The investigational device name, identifier, description and intended purpose, product owner and manufacturer information and estimated total quantity of the unregistered medical devices (general and in vitro diagnostic (IVD) medical devices) to be imported for the whole trial are to be stated in Section D and E respectively. For non-investigational devices, information on device name, identifier, product owner and estimated total quantity are required to be stated in Section F.

In addition, with effect from 1 June 2011, imports of Class C and D medical devices are subjected to TradeNet® Control. Applicants are required to provide HS Code in the application form and the Product Code will be issued by HSA upon approval.

For enquiry on HS codes, please contact Singapore Customs at 6355 2000 or visit their website.

It is the responsibility of the sponsor to obtain HSA approval and forward the approved CTM (Medical Device) form to the importer.

The approved CTM (Medical Devices) for the import of unregistered medical devices for clinical trial purpose, is valid for 6 months from the date of approval. If a subsequent CTM (Medical Devices) import approval is required, a request should be made using a new form.

Enquiries related to CTM (Medical Devices) application can be made to:

Clinical Trials Branch
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way #11-01 Helios
Singapore 138667

Tel No. 6866-3446

Last updated on 31 Jan 2012 16:51:22