|
The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on Medical Devices Software, under the Medical Devices Rules (MDR), 2017, to bring in specific regulatory requirements for medical device software and to align the requirements with globally harmonised practices. The guidance document is expected to bring in more clarity on the regulatory aspects for medical devices software.
"This guidance documents provides scope, definition, classification, standards, requirements of technical documents and quality management system applicable for medical device software. The applicants may refer this document while submission of application for grant of licence to manufacture or import medical device software for sale & distribution in the country," said Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI) while releasing the draft.
The regulator sought all concerned stakeholders to provide their comments for consideration within 30 days from the date of publication of the document, by filling an online form shared along with the draft document.
The document is to provide guidance to Indian manufacturers and importers for the submission of application to the licensing authority for obtaining license or permission for manufacturing or import of medical device software (including in vitro diagnostic (IVD) medical device software) under the MDR, 2017.
This is applicable to both Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD), which are defined by the regulator in the guidance document. The guideline should not be misconstrued as a new regulatory control on medical devices software including IVD device software, it added.
It defines active medical device, clinical evidence in relation to IVD and medical devices, clinical investigation, clinical performance evaluation, intended use of the medical device, investigational medical device, medical device and new IVD medical device, and predicate device.
The document suggests that applications for grant of Test licence for medical device software shall be submitted in the National Single Window System (NSWS) portal, while applications for grant of registration, or permission, or license (other than Test license) for medical device software shall be submitted in the online system for medical devices (MD online portal).
Welcoming the draft guidance document, the Association of Indian Medical Device Industry (AiMeD) said that t is a progressive step to strengthen India's digital health ecosystem.
"We propose hosting a webinar to educate stakeholders and invite feedback, with the aim of aligning India's framework with IMDRF and other global best practices. This will ensure patient safety while enabling Indian innovations to thrive internationally," said Rajiv Nath, forum coordinator, AiMeD.
Welcoming the draft guidance document, the Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies, has said that it is a proactive step framing a comprehensive regulatory framework for Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD), including artificial intelligence (AI), machine learning (ML), and cloud-based medical applications.
“This draft guidance reflects CDSCO’s commitment to keeping pace with the fast-evolving landscape of digital health technologies. By providing clarity on definitions, classification, and quality management requirements, it creates a foundation for safe, innovative, and globally competitive MedTech software solutions from India,” said Pavan Choudary, chairman, MTaI.
MTaI also highlighted that while the guidance is a welcome step, the final version should streamline compliance requirements for low-risk SaMDs to ensure regulatory proportionality and ease of implementation.
It should align technical and quality standards with global best practices, including those developed by IMDRF, US FDA, and the EU MDR framework, and provide greater clarity on clinical evaluation protocols and algorithm change management, particularly for AI/ML-based medical devices.
“We look forward to continuing our engagement with the regulator to ensure that the final framework remains innovation-friendly, risk-proportionate, and harmonized with global best practices,” added Choudary.
|