Conditions of supply of medical devices on Transition List
Supply of medical devices on the Transition List (T-List) is permitted, subject to the fulfillment of the following conditions:
The Registrant shall inform Health Sciences Authority of any product-related problems and adverse events arising from the use of the device on the T-List that have been reported to the Registrant or the product owner in accordance with the provisions specified in the Health Products Act and Health Products (Medical Devices) Regulations.
The Registrant shall not issue any advertisement or document that contains any statement to the effect, whether directly or indirectly, that the use of a medical device on the T-List is being promoted or endorsed by the Health Sciences Authority.
The intended use and indications for use of the medical device must be clearly stated in your product presentation and/or advertisement, inclusive of brochures, pamphlet and others.
The product presentation and/or advertisement, inclusive of brochures, pamphlet and others shall not contain any claims related to the following scheduled diseases and conditions: blindness, cancer, cataract, drug addiction, deafness, diabetes, epilepsy or fits, hypertension, insanity, kidney disease, leprosy, menstrual disorders, paralysis, tuberculosis, sexual function, infertility, impotency, frigidity and conception and pregnancy.
For professional-use only medical devices, the supply of the device is restricted to the qualified practitioner and shall not be advertised to the general public.
In relation to the Transition List for supplementary applications, the cancellation of the parent device listing would invalidate the supplementary application.
 |
Transition List
Additional Notes:
For more information on the T-List, please refer to these
slides.For the full list of model numbers on the T-List, please refer to the list of configurations that was submitted to HSA during product registration by the Registrant. You may obtain this list from the Registrant.
TradeNet® Declaration Procedures for Medical Devices that are listed on the Transition list
HS Codes that are controlled solely by Medical Device Branch
This document provides the procedure to facilitate Import Permit applications via TradeNet® for medical devices listed on the Transition List which use HS Codes that are controlled solely by MDB. Please refer to MDB Circular.
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 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.
Class C and D Medical Device Transition List
Class B Medical Device Transition List (Product Registration Applications)
From 1 Jan 2012, only class B devices that are registered or listed on the Transition List can be imported and supplied in Singapore.
Applications that have been declared by the Registrant to meet the Transition List criteria are published on the Class B Transition List.
Remaining applications are placed on the "Draft List for Class B Product Registration Applications".
Please verify and declare that the products on the draft list are eligible to be on the Transition List. In January 2012, the Class B Transition List will be updated every Friday for the declarations that were received in the previous week.
Class A Medical Device Transition List (Product Registration Applications)
From 1 Jan 2012, only class A devices that are registered, listed on the Transition List or exempted from product registration can be imported and supplied in Singapore. The Transition List is prepared in phases:
- Applications submitted before December 2011, that have been declared to meet the Transition List criteria, are published on the Class A Transition List.
2. Applications submitted before October 2011 are placed on the “Class A Product Registration Applications Draft List No. 2 (dated 28 October 2011)”.
Please verify and declare that the products on the draft list are eligible to be on the Transition List.
3. Applications submitted from 1 October to 30 November 2011 and other applications not on Draft List No.1 and No.2 will be placed on the “Draft List for Class A Product Registration Applications Draft List No.3 (14 Dec 2011)”.
Please verify and declare that the products on the draft list are eligible to be on the Transition List.
Class A and B Change Notification Transition List
Change Notification applications to class A and B SMDR Listings will qualify for Transition List if they are received by 30 Nov 2011.
NOTE: The Change Notification Transition List is strictly for Class A and B devices submitted in the change notification applications listed. Changes pertaining to Class C and D devices in the change notification applications do not qualify to be on the Transition List.
