The Health Sciences Authority (HSA) Singapore has initiated a new optional regulatory pathway – Change Management Program (CMP), specifically for SaMD that is incorporated into HSA’s Premarket Product Registration and Change Notification (CN) processes. CMP’s eligibility requires mandatory and valid conformance to latest standards of ISO 13485 and IEC 62304 throughout SaMD total product lifecycle (TPLC).
The purpose is to help product owners of SaMD manage and strike a balance between regulatory compliance and rapid iterations of their SaMD. The HSA is currently soliciting industry comments for this new guidance which they shared the draft last August 26, 2024.
The draft guidance emphasizes:
- timely implementation of software changes in accordance with SaMD TPLC-based regulatory framework.
- introduction of new concept – Pre-specified changes e.g. features’ improvement, bug fixes and others, whereby upcoming anticipated changes of SaMD (approved by HSA) could be implemented without the need for CN submission. Please also note exclusion criteria.
- that a similar, subsequent version of SaMD, could leverage on previously approved CMP documentation to expedite market access.
In addition, the following topics covered in this document:
- Eligibility criteria to enroll into CMP
- Application process
- Submission requirements
- Post-CMP approval
- Change Notification
- Leveraging on approved CMP
- Turn-Around-Time (TAT) and fees
The CMP and product registration/CN application will be reviewed concurrently. Regulatory outcome for product registration/CN and CMP will be determined independently (i.e. CMP regulatory decision does not affect the outcome of the product registration/CN).
The following are the details in which the stakeholders can share their comments:
Feedback period: 26 August 2024 to 21 October 2024
Feedback form: Consultation feedback form – Guidance on CMP for SaMD
Feedback method: Please email your feedback to HSA_MD_INFO@hsa.gov.sg by 21 October 2024 and with “Feedback on Guidance on CMP for SaMD” in the email subject header.
For more information, refer to the following link: Consultation on Guidance on Change Management Program (CMP) for SaMD.
If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.