Calendar

Medical Device Regulatory Timelines
The Health Products Act 2007 came into operation on 1st Nov 2007.

30 April 2010 — Last day for submitting Class C and Class D Medical Device for inclusion onto H.S.A.’s Transition List. (Note: Submitted dossier will be subjected to screening and evaluation).

From 10 August 2010 — Companies without Importer Licence will not be allowed to import medical devices. Companies without Wholesaler Licence will not be allowed to supply medical devices. (Note: To be eligible to apply for Importer or Wholesaler Licence, a company must have a valid GDPMDS certificate.)

From 10 August 2010 — Companies that manufactures finished medical devices is required to obtain a manufacturer's licence from HSA. (Note: To be eligible to apply for Manufacturer's License, a company must have a valid ISO 13485 certificate.)

From 10 August 2010 — Companies are prohibited from supplying unregistered Class C or Class D medical devices unless their product is listed on the SMDR or is on the Transition List.

31 August 2011 — Last day for submitting Class A and Class B Medical Device for inclusion onto H.S.A.’s Transition List. (Note: Submitted dossier will be subjected to screening and evaluation).

From 01 January 2012 — Companies are prohibited from supplying unregistered medical devices of all classes unless they are authorised by H.S.A or listed on the Transition List.

From 09 November 2020 — Singapore Standard SS620:2016 will be the standard use for certification and it will replace H.S.A. Technical Specification TS-01. There are some minor changes between SS620:2016 and TS-01.

Present — Certified to SS620:2016 or certified to ISO 13485:2016 with certificate scope covering Import, Distribution, Storage (if applicable) of the medical device types you intend to import and wholesale.

* The above information is subject to change, please check with H.S.A. for the latest updates.

Medical Device Regulatory Timelines
The Health Products Act 2007 came into operation on 1st Nov 2007.
30 April 2010 — Last day for submitting Class C and Class D Medical Device for inclusion onto H.S.A.’s Transition List. (Note: Submitted dossier will be subjected to screening and evaluation).
From 10 August 2010 — Companies without Importer Licence will not be allowed to import medical devices. Companies without Wholesaler Licence will not be allowed to supply medical devices. (Note: To be eligible to apply for Importer or Wholesaler Licence, a company must have a valid GDPMDS certificate.)
From 10 August 2010 — Companies that manufactures finished medical devices is required to obtain a manufacturer's licence from HSA. (Note: To be eligible to apply for Manufacturer's License, a company must have a valid ISO 13485 certificate.)
From 10 August 2010 — Companies are prohibited from supplying unregistered Class C or Class D medical devices unless their product is listed on the SMDR or is on the Transition List.
31 August 2011 — Last day for submitting Class A and Class B Medical Device for inclusion onto H.S.A.’s Transition List. (Note: Submitted dossier will be subjected to screening and evaluation).
From 01 January 2012 — Companies are prohibited from supplying unregistered medical devices of all classes unless they are authorised by H.S.A or listed on the Transition List.
From 09 November 2020 — Singapore Standard SS620:2016 will be the standard use for certification and it will replace H.S.A. Technical Specification TS-01. There are some minor changes between SS620:2016 and TS-01.
Present — Certified to SS620:2016 or certified to ISO 13485:2016 with certificate scope covering Import, Distribution, Storage (if applicable) of the medical device types you intend to import and wholesale.
* The above information is subject to change, please check with H.S.A. for the latest updates.