Singapore: HSA Launches Pilot for Change Management Program (CMP) Targeting SaMD and AI-Driven Innovations (w.e.f 4 December 2024)

Singapore's Health Sciences Authority (HSA) is taking a significant step toward modernizing regulatory frameworks with its pilot for the Change Management Program (CMP), which will be effective on 4 December 2024. This initiative focuses on Software as a Medical Device (SaMD), including cutting-edge machine learning-enabled solutions. By streamlining regulatory processes, the CMP ensures safer, faster access to innovative technologies while maintaining stringent oversight.

What is a Change Management Program (CMP)?

The CMP is an optional regulatory pathway designed for SaMD and integrated into HSA’s Premarket Product Registration and Change Notification (CN) processes. It introduces the innovative concept of pre-specified changes, allowing for predefined, regulatory-compliant modifications to SaMD during its lifecycle.

Change Management Program Enrolment

HSA provides 2 steps to enroll in the program:

Step 1: Upload all required documents on MEDICS when submitting product registration / CN application.

For the CN application, the applicant may select the following change types:

• Class B SaMD: Other Notification Changes (Verified by HSA before submission)

• Class C SaMD: Other Technical (Verified by HSA before submission)

Ensure the email blast distributed on 4 December 2024 is uploaded in the ‘HSA email’ section as a supporting document.

Step 2: Email HSA_MD_Info@hsa.gov.sg to inform HSA of the CMP enrolment with the following information:

• Email subject header: CMP enrolment

• MEDICS job reference number

• Company name

• Submission date

• Device name

This pilot represents an important opportunity for stakeholders to adapt to dynamic AI advancements.

Source: Health Sciences Authority (HSA)