SAR Registration Support Initiative window and fee-waiver pathway

记录详情

数值

Inaugural submissions are open until 31 December 2026; recurring annual windows run from 1 October to 31 December; eligible companies are notified of fee-waiver eligibility by April of the following year and must submit registration within one year

单位

application schedule and registration deadline

数值类型

observation

适用人群

Medical-device companies and healthcare practitioners handling eligible unregistered devices previously accessed through Singapore's Special Access Route

分母口径

Devices must satisfy HSA Criteria A or Criteria B; fee waiver applies to eligible evaluation fees, not an automatic registration approval

统计期间

HSA page updated 26 August 2026; first window through 31 December 2026

检索日期

2026-09-10

发布日期

2026-08-26

地理范围

sg.geo.country.singapore

备注

Private healthcare institution and clinic endorsement requests begin through the Academy of Medicine, Singapore, from 1 October 2026. HSA's public DHCPL page provides an abstract and directs eligible healthcare professionals to the MOH Alert System in the Health Professionals Portal for full details.

日期表示本记录的统计期间与适用范围。核验日期并不代表规则目前已经生效。

资料来源

• https://www.hsa.gov.sg/medical-devices/registration-of-medical-devices/special-access-routes/registration-support-initiative-to-encourage-registration-of-unregistered-medical-devices-accessed-through-sar/ 访问日期 2026-09-10