Cybersecurity Labelling Scheme for Medical Devices (Level 2)
The Cybersecurity Labelling Scheme for Medical Devices (CLS(MD)) is a joint initiative by the Cyber Security Agency of Singapore (CSA), Ministry of Health (MOH), Health Sciences Authority (HSA), and Synapxe as part of efforts to improve medical device cybersecurity.
- Validity
- Up to 3 years
- Processing time
- 2 days
- Issuing authority
- CYBER SECURITY AGENCY OF SINGAPORE (CSA)
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Who needs the Cybersecurity Labelling Scheme for Medical Devices (Level 2)
This licence applies to Singapore businesses registered under the following SSIC industry codes:
- Voluntary / supplementaryGroup 325 — MANUFACTURE OF MEDICAL AND DENTAL INSTRUMENTS AND SUPPLIES
Includes: 32501 Manufacture of medical research and clinical diagnostic instruments and supplies, 32502 Manufacture of medical disposables and surgical supplies, 32503 Manufacture of implantables and artificial limbs, 32504 Manufacture of ophthalmic goods
- Voluntary / supplementary62013 — Development of software for cybersecurity
Required documents and prerequisites
Items the applicant typically needs ready before submitting:
- Declaration of Conformity
- To declare that the device met with the relevant cybersecurity level security provision.
- Supporting Evidence Document
- To provide evidence that demonstrates the product's compliance with requirements.
- Download application templates here.
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