Software as a Medical Device (SaMD) Registration

As the digital health field continues to evolve, it becomes paramount to understand and comply with the regulations for ensuring a successful market entry as well as product safety and efficacy. Successfully navigating the Regulatory landscape for SaMD registration and meeting medical device software requirements demands expertise and strict adherence to specific guidelines.

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Software as a Medical Device (SaMD) Registration Overview

Software as Medical Device (SaMD), also called Medical Device Software (MDSW) is the latest booming topic in the healthcare segment. The global SaMD market is estimated to be valued at US $86.5 billion by 2027, at a CAGR of 21.9% from 2020 to 2027. This growth is triggered by various factors of SaMD compliance such as, adoption of Internet of Things (IoT), digital healthcare platforms and adoption of software for continuous monitoring of physiological parameters by healthcare providers for remote assistance. This has been further accelerated due to the COVID pandemic, which has necessitated remote healthcare services and in turn created the need for a streamlined process of Software as a Medical Device (SaMD) registrations. There are three types of software related to Medical Devices based on Software as a medical device (SaMD) classificationsuch as:

  • Software in a Medical Device (SiMD)
  • Software as Medical Devices (SaMD)
  • Software used in manufacturing/maintenance of a medical device

Global Regulatory Scenario:

With respect to SaMDs, various types are being used for various applications such as, screening and diagnosis, monitoring and alerting, disease management, etc. The Health agencies of developed or highly regulated countries such as the EU, the US, Canada, and Australia have defined regulations around SaMDs and some of them have already developed guidance documents while others are in the process. Some semi-regulated and non-regulated markets consider such software as medical devices but do not have differentiated and specific guidelines  for Software as a Medical Device (SaMD) classification. They follow the internationally accepted harmonized guidelines for evaluation and approval of the software. Below listed are some of the prominent guidelines available on SaMDs:

  • IMDRF guidance for classification, QMS, cybersecurity assessment, clinical evaluation
  • EU MDR has detailed information on this device category
  • MDCG guidance on qualification and classification of SaMD, CER / PER requirements for SaMD
  • US FDA guidance on cybersecurity, clinical evaluation and registration requirements for different types of software such as, decision systems, PACS, mobile applications, etc.
  • Health Canada guidance document on definition and classification
  • TGA’s new regulations for Software-based Medical Devices, which would be effective from August 2020

The registration of SaMD in other global markets shall be handled in a case by case approach and requires close interaction with the respective health agency for approval. The general pathway followed for registration of SaMD includes:

  • Determining whether a given software qualifies as a SaMD
  • Classification of the devices based on the risk involved
  • Identify applicable standards and data requirements by the concerned Health Agency
  • Generate data as required by the respective Agency
  • Compilation of technical file as per country requirement
  • Submission and query resolution till approval 
  • Post-approval life cycle management

Software as a Medical Device (SaMD) Registration Services

Software as a Medical Device (SaMD) Registration

  • Regulatory Intelligence Services
  • Regulatory Due Diligence / Strategy Reports 
  • Qualification and Classification of SaMD
  • Identification of Applicable Standards
  • Gap Analysis of Source Documents
  • SaMD Registration
  • Quality Management System (QMS) Compliance
  • Consultation Services for Cybersecurity Assessment 
  • Consultation Services on Clinical Evaluation Studies
  • Compilation of Clinical Evaluation Reports (CERs) / Product Evaluation Reports (PERs) Etc.
  • Post-approval Change Management