Class A Medical Device Register

During the HSA Industry Briefing held on 28 February 2018, all Class A Medical Devices (sterile and non-sterile) will have exception from product registration requirement.

(i) For existing Class A sterile medical device listing on Singapore Medical Device Register (SMDR) with importer/local manufacturer

HSA will be performing a mass port over of all Class A device listings that are active on SMDR as of 1st June 2018. These device listings will be ported over to the appointed importers and/or local manufacturers licences, whichever is applicable. All ported over Class A device listings will be shown on the Class A Medical Device Register from 12th June 2018 onwards.

With the above transition, all Class A device listings will be removed from SMDR by 19th June 2018.

(ii) For new Class A sterile and non-sterile medical devices moving forward

Targeting from 1st June 2018 onwards, importers and local manufacturers are required to declare all Class A Medical Devices in the Class A Exemption List prior to import/supply in Singapore. All Class A sterile and non-sterile medical devices will be listed on the Class A Medical Device Register for public view.

• Amendment for Dealer’s license/Submission of update of Class A Medical Device Exemption List

• Submission of Update of Class A Medical Device Exemption List E-guide

There will be no change to the declaration procedure and dealers are responsible to ensure the information declared under the importer/manufacturer licences are accurate and complete. Dealers may proceed to update the Class A Exemption List via the MEDICS e-service at any time point prior to the import of the Class A Exempted Medical Devices.

All updates will be reflected on the Class A Medical Device Register in real time and only entries with ‘ACTIVE’ status will be shown on the Register for public view.

Contact us at info@arqon.com