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Fourth Revision Of GN-35: Guidance On Special Access Routes (SAR)

The Health Sciences Authority (HSA) of Singapore published the 4th Revision of GN-35: Guidance on Special Access Routes (SAR) in January 2023. The major highlighted change of this revised regulation is regarding the stipulated turnaround-time (TAT) of 28 working days for Special Access Route (SAR) application review for specific categories of unregistered Class D medical devices. These devices, for local clinical use, demand the regulatory oversight of both HSA as well as Ministry of Health (MOH).

Specific categories of Class D unregistered medical devices refer to the following:

  1. New technologies and state-of-the-art medical devices for clinical use on patients, including novel indications for existing medical devices or technologies.
  2. Unregistered implants that can fail post-surgery and give rise to long term complications.

This update supplements a related-major-amendment (Rev 2) made in April 2022, which you can read about here.

Click here to see the fourth revision of GN-35: Guidance on Special Access Routes (SAR).

If you have any queries regarding the announcement, please get in touch or click the button below.

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