The meeting is about providing guidance on the regulations and requirements for Medical Device Software in India, as outlined in a draft guidance document by the Central Drugs Standard Control Organization (CDSCO).
Draft Guidance Document on Medical Device Software
This document outlines the regulatory framework for Medical Device Software under the Medical Devices Rules, 2017, and invites stakeholder comments.
- The draft guidance document aims to clarify regulatory aspects for Medical Device Software.
- It includes definitions, classifications, standards, and requirements for technical documents and Quality Management Systems (QMS).
- Stakeholders are encouraged to provide feedback via a Google form within 30 days of publication.
Purpose of the Guidance Document
The guidance aims to assist manufacturers and importers in obtaining licenses for Medical Device Software.
- It provides a framework for submitting applications to the Licensing Authority (LA).
- The document applies to software that meets the definition of a “Medical Device” as per MDR-2017.
Scope of the Guidance Document
The guidance applies to software categorized as either Software in a Medical Device (SiMD) or Software as a Medical Device (SaMD).
- It clarifies that not all healthcare software qualifies as a medical device.
- SaMD and SiMD are collectively referred to as “Medical Device Software” in the document.
Submission Process for Applications
Details on how to submit applications for Medical Device Software licenses are provided.
- Applications for test licenses must be submitted via the National Single Window System (NSWS) portal.
- Other applications for registration or licenses should be submitted through the Medical Devices online portal.
Key Definitions Related to Medical Device Software
The document defines critical terms relevant to Medical Device Software.
- Definitions include “Active medical device,” “Clinical evidence,” “Intended use,” and “Medical Device.”
- These definitions are essential for understanding the regulatory framework.
Types of Medical Device Software
The document categorizes Medical Device Software into two main types: SiMD and SaMD.
- SiMD refers to software that is part of a medical device, while SaMD operates independently.
- Examples of each type are provided to illustrate their applications.
Risk-Based Classification of Medical Device Software
Medical Device Software is classified based on risk levels as per MDR-2017.
- The classification includes four risk categories: Class A (low risk), Class B (low moderate risk), Class C (moderate high risk), and Class D (high risk).
- The classification is based on the intended use and applicable parameters.
Applicable Standards for Medical Device Software
The document outlines the standards that Medical Device Software must conform to.
- Compliance with Bureau of Indian Standards or international standards like ISO and IEC is required.
- Specific standards mentioned include ISO 13485 for Quality Management Systems and ISO 14971 for risk management.
Quality Management System (QMS) Requirements
The guidance emphasizes the importance of a Quality Management System for Medical Device Software.
- A QMS is essential for ensuring compliance with regulatory requirements.
- The document provides a framework for implementing a QMS tailored to Medical Device Software.
Quality Management System for Medical Device Software
The establishment of a Quality Management System (QMS) is essential for manufacturers of medical device software to ensure compliance with regulatory requirements.
- Indigenous manufacturers must maintain procedures and records demonstrating QMS conformance.
- An undertaking of compliance with QMS requirements is required for manufacturing license applications.
- Overseas manufacturers must ensure their facilities comply with QMS and submit a notarized QMS certificate for import license applications.
Regulatory Pathway for Medical Device Software
The regulatory pathway outlines the steps necessary for marketing medical device software in the country.
- Flow charts illustrate the regulatory processes for both general medical device software and in vitro diagnostic (IVD) software.
- Manufacturers must follow specific licensing authorities and procedures as per the Medical Device Rules (MDR-2017).
Licensing Authorities for Medical Device Software
Licensing authorities are responsible for granting licenses for the manufacturing or import of medical device software.
- Different classes of medical devices (A, B, C, D) have varying licensing requirements.
- Class A devices are exempt from licensing but must be registered online.
- The Central Licensing Authority (CLA) and State Licensing Authority (SLA) oversee licensing processes.
Documents Required for Test License Applications
A comprehensive list of documents is necessary for obtaining a test license for clinical investigations or evaluations of medical device software.
- Applicants must submit online applications along with required documents and fees.
- Specific checklists for documentation are provided in the guidelines.
Clinical Investigation and Performance Evaluation Requirements
Clinical investigations for investigational medical devices and performance evaluations for new IVDs must adhere to strict regulatory guidelines.
- Permission from the CLA is mandatory before conducting clinical investigations.
- Applications must include detailed documentation and fees as specified in the MDR-2017.
Permission for Manufacturing and Importing Investigational Devices
Manufacturers must obtain permission before importing or manufacturing investigational medical devices or new IVDs.
- Applications must be submitted through the MD Online portal with requisite documents and fees.
- Clinical data generated during investigations must be included in the application.
Post-Marketing Regulatory Requirements
Manufacturers must comply with post-marketing requirements to ensure ongoing safety and effectiveness of medical device software.
- License holders must fulfill conditions of their licenses and notify authorities of any adverse events.
- Post-marketing surveillance (PMS) is essential for monitoring device performance and addressing non-conformities.
Document Checklists for License Applications
Detailed checklists outline the necessary documentation for various types of license applications.
- Each checklist specifies required forms, supporting documents, and justifications for non-applicability.
- The checklists ensure that all regulatory requirements are met for the approval process.
Checklist for Class A and B IVD Medical Devices
This checklist outlines the requirements for obtaining a manufacturing license for Class A and B in vitro diagnostic medical devices under the Medical Devices Rules, 2017.
- Covering letter and constitution details of the manufacturer are required.
- A site or plant master file must be submitted as per Appendix I of the Fourth Schedule.
- A device master file must be included as specified in Appendix III.
- An essential principles checklist demonstrating conformity to safety and performance is necessary.
- An undertaking confirming compliance with the Fifth Schedule of MDR 2017 must be signed by the manufacturer.
- Regulatory certificates, including inspection reports and quality management system certificates, are required.
- Specific evaluation reports and performance evaluation reports are needed for Class B devices.
- Stability study reports and product inserts must be provided.
- Fees challan and legal form are mandatory.
Checklist for Class C and D Medical Devices
This checklist details the requirements for obtaining a manufacturing license for Class C and D medical devices under the Medical Devices Rules, 2017.
- A covering letter and application form must be submitted.
- The constitution of the firm and site ownership documents are required.
- A comprehensive plant master file must be provided, including details on personnel, equipment, and quality assurance.
- Quality management system requirements must be documented, including an undertaking of compliance with the Fifth Schedule.
- A device master file must be submitted, including risk analysis and validation data.
- Approval from the Department of Animal Husbandry is necessary for veterinary devices.
- Additional documents may be required based on specific device characteristics.
Checklist for Class C and D IVD Medical Devices
This checklist specifies the requirements for obtaining a manufacturing license for Class C and D in vitro diagnostic medical devices under the Medical Devices Rules, 2017.
- A covering letter and constitution details of the manufacturer are required.
- A site or plant master file must be submitted, detailing layout and key personnel.
- Quality management system documentation is necessary, including an undertaking of compliance.
- Regulatory certificates, including inspection reports and quality management system certificates, must be provided.
- A device master file must be included, detailing device specifications and essential principles checklist.
- Stability study reports and clinical evidence are required for the application.
- A fee challan and legal form must be submitted.
Checklist for Import License for Medical Devices
This checklist outlines the requirements for obtaining an import license for medical devices under the Medical Devices Rules, 2017.
- A covering letter and application form must be submitted.
- A power of attorney from the authorized agent is required, authenticated in India.
- Copies of wholesale or manufacturing licenses of the authorized agent must be included.
- Regulatory certificates, including free sale certificates from the country of origin, are necessary.
- Quality certificates for the manufacturing site must be provided.
- A plant master file and device master file must be submitted, detailing device specifications and compliance.
- Additional documents may be required based on specific device characteristics.
Checklist for Import License for IVD Medical Devices
This checklist specifies the requirements for obtaining an import license for in vitro diagnostic medical devices under the Medical Devices Rules, 2017.
- A covering letter and power of attorney must be submitted, authenticated in India.
- A self-attested copy of the wholesale or manufacturing license is required.
- Regulatory certificates, including free sale certificates from the country of origin, must be provided.
- Quality management system certificates for manufacturing sites are necessary.
- A site or plant master file and device master file must be included, detailing device specifications and compliance.
- Stability study reports and clinical evidence are required for the application.
- A fee challan and legal form must be submitted.
How Titans Medical Consulting Can Help
At Titans Medical Consulting, we specialize in guiding manufacturers and importers through every stage of the medical device software regulatory process in India — from determining classification and preparing technical documentation to ensuring QMS compliance and successful license submissions through CDSCO portals.
Our expert regulatory team ensures your SaMD or SiMD meets all applicable standards and documentation requirements under MDR-2017, helping you achieve faster market access with full compliance confidence.
If you’re developing or importing medical device software, Titans Medical Consulting can be your trusted partner for end-to-end regulatory support.