CDSCO Medical Device Software Guidelines 2026-Impact on Standalone Software & Software-Based Devices
The Medical Device Software Guidelines, 2026 issued by CDSCO introduce significant regulatory expectations for standalone Medical Device Software (MDSW) and software-based medical devices.
In this webinar, the expert speakers from Arogya Compliance explain the practical implications of the latest guidelines, helping manufacturers, importers, MedTech startups, healthcare technology companies, and regulatory professionals understand how to determine whether software qualifies as a medical device, assess regulatory applicability, and prepare for compliance under the Medical Devices Rules.
Topics Covered
Issues faced by importers and manufacturers
What has changed from the Draft Guidelines 2026
Medical Device Software (MDSW) and Standalone MDSW
Intended Use and Medical Purpose
Types of Medical Device Software
Software that is not considered MDSW
General Wellness Software – When does it become MDSW?
Risk-based classification of Medical Device Software
Actual Manufacturer vs. Legal Manufacturer
Regulatory pathway for Medical Device Software
Test Licence requirements (Shelf Life, Quality Standards & Raw Material Testing)
Post-Market Surveillance (PMS)
Labelling requirements
Cybersecurity requirements
Data Protection requirements
Impact of the Guidelines on businesses
Software invoicing and Software Bill of Materials (SBOM)
Penalties for non-compliance
Who Should Watch?
Medical Device Manufacturers
Software as a Medical Device (SaMD) Developers
MedTech Startups
Importers and Authorized Representatives
Regulatory Affairs Professionals
Quality Assurance Professionals
Legal and Compliance Professionals
Healthcare Technology Companies
Consultants and Regulatory Advisors
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