Overview
The Medical Device Branch (MDB) is the controlling agency (CA) for the import of medical devices in Singapore through TradeNet®.
With effect from 1 June 2011, TradeNet® Control will be activated for Class C and D medical devices.
From 1 January 2012, TradeNet® Control will be activated for Class A and B medical devices, and therefore effectively all classes of medical devices (Class A, B, C and D) will have import controls through TradeNet® .
For information on how to perform TradeNet® declarations for medical devices, please refer to the Industry briefing slides.
Industry Briefing on TradeNet® Controls for Medical Devices
Presentation slides from Industry briefings can be downloaded from the below link.
Medical Device Branch Circular
With the implementation of control for the import of medical devices, this circular provides traders and industry useful information on the requirements and the procedures to facilitate the process of Import Permit applications via TradeNet®.
Note: The circular is also posted on the Singapore Customs' website as of 18 May 2011. This circular shall be superseded by the circular dated 25 November 2011 in line with the full implementation of the Health Products (Medical Device) Regulations 2010.
[UPDATES] From 01 January 2012 onwards, HSA will implement TradeNet® controls for all medical devices (Class A, B, C and D) including Class A medical devices that are exempted from product registration. Useful information on the requirements and procedures is provided in the circular dated 25 November 2011 below.
Note: The circular is also posted on the Singapore Customs' website as of 25 November 2011.
List of HS Code controlled by Medical Device Branch
Please refer to the following document for the list of AHTN 2007 HS Codes controlled by Medical Device Branch. This list shall be superseded by the list of AHTN 2012 HS Codes with effect from 01 January 2012.
[UPDATES] From 01 January 2012 onwards, HSA will implement the HS Codes as per the ASEAN Harmonized Tariff Nomenclature (AHTN) 2012 for use with the TradeNet® version 4.1 system. Please refer to the following document for the list of AHTN 2012 HS codes controlled by Medical Device Branch.
TradeNet® Declaration Procedures for Medical Devices on Singapore Medical Device Register (SMDR), Transition List and GN-22
HS Codes that are controlled solely by Medical Device Branch
The MDB Circular provides procedures to facilitate Import Permit declarations via TradeNet® for medical devices that use HS codes controlled solely by Medical Device Branch.
To obtain these HS codes and their relevant HSA Product codes, please refer to the following:
Singapore Medical Device Register (SMDR)
HS Codes that are Jointly Controlled by Medical Device Branch & other Controlling Agency (CAs)
This document provides the procedure to facilitate Import Permit applications via TradeNet® for medical devices listed on the Singapore Medical Device Register (SMDR) and Transition List which use HS Codes that are Jointly Controlled by MDB and other controlling Agency (CAs).
Please click here to refer to the document.
Useful Links
For enquires related to HS codes, please click here or contact Singapore Customs at 6355 2000.
For more information on the regulatory requirements of medical devices for Clinical Trials purposes, please click here.
For the guidances and application forms for Authorisation routes, refurbished medical devices and custom made medical devices, please click here.
Contact Information
