Software as a Medical Device (SaMD) is increasingly
important in healthcare innovation, standalone software that performs medical
purposes such as diagnosis, monitoring, prediction, or treatment without
requiring a physical hardware medical device. In India, SaMD falls under the
regulatory framework of the Central Drugs Standard Control Organisation (CDSCO)
as defined by the Medical Devices Rules, 2017.
One of the key aspects of medical device approval, including
SaMD in India, involves identifying a predicate device for regulatory
submissions. However, novel SaMD products frequently face challenges in
predicate device identification, leading to regulatory delays and uncertainty.
This blog explores why these challenges arise and how innovators should
approach them under the CDSCO regulatory regime.
What Does “Predicate Device” Mean under CDSCO?
Under the Medical Devices Rules, 2017, a predicate device is
defined as a device that:
Was approved for manufacture, sale, or import in India by
the Central Licensing Authority, and
Has similar intended use, material of construction, and design characteristics
as the device being proposed for licensing.
In simple terms, a predicate device in India is a previously
licensed device in the Indian market that matches the new device’s purpose and
design, and serves as a reference point to support regulatory approval
applications.
Why Predicate Devices Matter for SaMD
For traditional medical devices, predicate devices give
regulators confidence that a new product performs as safely and effectively as
an existing one. This concept helps streamline:
- Regulatory
review processes
- Evaluation
of performance evidence
- Risk
assessments
However, for Software as a Medical Device (SaMD) where the
product is purely software, identifying such predicates is significantly more
complex due to rapid innovation and diverse software capabilities.
Key Challenges in Predicate Device Identification for
SaMD
1. Limited Number of Similar Past Approvals
Many SaMD products (especially those using advanced AI/ML
models or unique diagnostic logic) may not have existing licensed counterparts
in the Indian market. Since a predicate device must already be approved in
India, this makes it difficult to find a matching reference.
When no predicate exists, regulators may treat the software
as novel or first of its kind, potentially triggering additional requirements
such as local clinical data or SEC (Subject Expert Committee) review to
demonstrate safety and performance.
2. Defining Equivalence for Software Functions
Unlike traditional devices with physical components, SaMD
functionality is based on algorithms, data processing, and clinical logic.
Establishing similarity in intended use and design characteristics for digital
products becomes subjective because:
- Software
behavior can evolve over time via updates
- Similar
clinical purpose doesn’t always equate to similar algorithmic design
- Software
may have multiple modules or outputs that don’t map easily to a single
predicate device
This makes preparing predicate comparisons more challenging
and increases the risk of regulatory queries or delays.
3. Evolving Indian Regulatory Guidance on Software
While the Medical Devices Rules, 2017, apply to SaMD, India
has historically lacked detailed, software-specific guidance though CDSCO
recently released a Draft Guidance on Medical Device Software to clarify
regulatory expectations for Software in a Medical Device (SiMD) and SaMD. This
draft aims to:
- Clarify
risk classification for software
- Define
documentation expectations
- Align
Indian practices with global standards
However, since this guidance is still in draft form and open
for stakeholder input, practical interpretations of predicate device
requirements for SaMD continue to evolve.
4. Increased Documentation Requirements
For SaMD predicate comparisons, manufacturers must often
provide:
- Detailed
descriptions of software functions
- Evidence
of similarity in clinical usage
- Technical
specifications including algorithm design
- Performance
validation reports
This level of documentation is more extensive than
traditional hardware device comparisons and requires careful legal and
technical argumentation.
Impacts of Predicate Challenges
When appropriate predicates are not identified:
·
Regulatory submissions may be delayed
·
Additional clinical evaluations may be required
·
SEC expert reviews could extend timelines
·
Approval might hinge on more conservative
assessments of safety and performance
These challenges can impact time-to-market and development
costs for innovative SaMD products in India.
Best Practices to Navigate Predicate Challenges
To improve chances of regulatory success:
·
Conduct thorough analysis to identify any
candidate predicate devices in the Indian database that match intended use and
functional characteristics.
·
Prepare comprehensive technical dossiers that
explain similarities and justify differences.
·
Engage with CDSCO early (e.g., via
pre-submission queries) to clarify expectations.
·
Stay updated on the evolving draft guidance on
medical device software as it shapes SaMD regulation in India.
Conclusion
Identifying a suitable predicate device for novel SaMD
products under India’s CDSCO regime is both critical and challenging. Because
SaMD often incorporates advanced digital logic and has fewer historical
approvals in India, developers must be prepared for detailed technical
comparisons, possible clinical evidence requirements, and evolving regulatory
expectations. Navigating these complexities with a clear strategy is key to a
successful SaMD launch in the Indian market.
Facing predicate challenges for novel SaMD under CDSCO?
Titans Medical Consulting helps streamline approvals and post-approval change
management for smoother global market access.
Sources:
- Central
Drugs Standard Control Organization (CDSCO) Medical Devices Rules, 2017
Ministry of Health & Family Welfare, Government of India - CDSCO
Draft Guidance on Medical Device Software (SiMD & SaMD)
Directorate General of Health Services, MoHFW - CDSCO
Online System for Medical Devices (SUGAM Portal)
Government of India - CDSCO
Device Classification & Risk-Based Framework
MoHFW, Government of India - Gazette
of India Notifications on Medical Devices Regulation
Ministry of Health & Family Welfare