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Singapore: Industry consultation for guidance on Change Management Program (CMP) for SaMD

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In brief

The Medical Devices Cluster (MDC) of the Health Sciences Authority (HSA) has released a draft guidance on the Change Management Program (CMP) for Software as a Medical Device (SaMD). CMP is the new optional regulatory pathway that aims to streamline the SaMD regulatory framework and facilitate timely implementation of software changes for registered SaMDs in Singapore.

Further details on the CMP have been released in a consultation paper.

Background

On 26 August 2024, the HSA published a consultation paper setting out the proposed CMP for SaMD for industry consultation.

The HSA recognized that the prevailing regulatory framework may not be suited for the rapidly evolving nature of SaMDs. SaMD product owners face challenges in adhering to regulatory requirements, which consist of ensuring compliance and obtaining regulatory approvals that can impact the timeliness of implementing SaMD changes. Accordingly, the HSA has sought to introduce and adopt a modern regulatory framework that aims to expedite the approval process for certain types of changes.

The CMP is a new optional regulatory pathway incorporated into the HSA’s Premarket Product Registration and Change Notification processes. It streamlines the SaMD Total Product Life Cycle (TPLC)-based regulatory framework to facilitate a timely approval process and improve the effectiveness and safety of SaMD.

This initiative is part of the HSA’s efforts to adopt a modern regulatory framework that embraces agile methodologies and risk-based assessment.

Eligibility and application

To enroll in the CMP, the SaMD product must meet specific eligibility criteria, including adherence to standards for a quality management system (i.e., ISO 13485) and certain life cycle requirements for SaMD (i.e., IEC 62304).

An application for the CMP can be made through a premarket product registration or Change Notification (CN) application for SaMD registered on the Singapore Medical Device Register (SMDR).

Submission Requirements

Key submission requirements include documents demonstrating the following quality assurance processes:

  • Timely review of recognized standards through the SaMD TPLC: Demonstrate that processes are in place to enable timely review or gaps analysis.
  • SaMD versioning and traceability processes: Demonstrate processes throughout the SaMD TPLC to enable identification and post-market traceability/follow-up in the event of software changes and/or field safety corrective actions.
  • Cybersecurity and data safety management: Ensure accreditation of international safety standards or risk analysis, surveillance, timely detection and management of cybersecurity-related threats.
  • Safety issues management, including adverse events and FSCA reporting: Demonstrate proactivity and efficiency in responding to safety-related issues.
  • Risk management of third-party and open-source software: This includes monitoring potential hazards and risks, implementing risk control measures, etc.
  • Post-market data analysis and change management: Establish processes to consistently improve the SaMD and ensure potential safety risks are identified and mitigated.

Pre-specified changes

The CMP also introduces the concept of pre-specified changes, which are upcoming anticipated changes that can be implemented without undergoing a new CN application, provided they meet certain criteria and are documented in the initial submission.

This allows for a more efficient regulatory review process.

However, changes resulting in an alteration of SaMDs’ intended use, indication for use and method of use, and changes to device particulars published on the SMDR are excluded from making pre-specified changes.

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The industry consultation is ongoing until 21 October 2024.

The HSA has been taking an active stance in respect of the governance of SaMDs. Our previous alert sets out the HSA’s updates to its SaMD regulatory framework in 2022, which shows the rapidly evolving landscape of SaMDs in Singapore.

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Andy Leck is the head of the Intellectual Property and Technology (IPTech) Practice Group and a member of the Dispute Resolution Practice Group in Singapore. He is a core member of Baker McKenzie's regional IP practice and also leads the Myanmar IP Practice Group. Andy is recognised by reputable global industry and legal publications as a leader in his field. He was named on "The A-List: Singapore's Top 100 lawyers" by Asia Business Law Journal 2018. In addition, Chambers Asia Pacific notes that Andy is "a well-known IP practitioner who is highlighted for his record of handling major trade mark litigation, as well as commercial exploitation of IP rights in the media and technology sectors. He's been in the industry for a long time and has always been held in high regard. He is known to be very fair and is someone you would like to be in the trenches with you during negotiations." Furthermore, Asian Legal Business acknowledges Andy as a leading practitioner in his field and notes that he “always gives good, quick advice, [is] client-focused and has strong technical knowledge for his areas of practice.” Andy was appointed by the Intellectual Property Office of Singapore (IPOS) as an IP Adjudicator to hear disputes at IPOS for a two-year term from April 2021. He has been an appointed member of the Singapore Copyright Tribunal since May 2010 and a mediator with the WIPO Arbitration and Mediation Center. He is also appointed as a Notary Public & Commissioner for Oaths in Singapore. He previously served on the International Trademark Association’s Board of Directors and was a member of the executive committee.

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Ren Jun Lim is a principal with Baker McKenzie Wong & Leow. He represents local and international clients in both contentious and non-contentious intellectual property matters. He also advises on a full range of healthcare, as well as consumer goods-related legal and regulatory issues. Ren Jun co-leads Baker McKenzie Wong & Leow's Healthcare as well as Consumer Goods & Retail industry groups. He sits on the Law Society of Singapore IP Committee and on the Executive Committee of the Association of Information Security Professionals. He is also a member of the Vaccines Working Group, Singapore Association of Pharmaceutical Industries, a member of the International Trademark Association, as well as a member of the Regulatory Affairs Professionals Association. Ren Jun is ranked in the Silver tier for Individuals: Enforcement and Litigation and Individuals: Prosecution and Strategy, and a recommended lawyer for Individuals: Transactions by WTR 1000, 2020. He is also listed in Asia IP's Best 50 IP Expert, 2020, recognised as a Rising Star by Managing IP: IP Stars, 2019 and one of Singapore's 70 most influential lawyers aged 40 and under by Singapore Business Review, 2016. Ren Jun was acknowledged by WTR 1000 as a "trademark connoisseur who boasts supplementary knowledge of regulatory issues in the consumer products industry." He was also commended by clients for being "very responsive to enquiries and with a keen eye for detail, he is extremely hands-on. His meticulous and in-depth approach to strategising is key to the excellent outcomes we enjoy."

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