Introduction to Software as Medical Device Category
Software as a Medical Device (SaMD) refers to software intended to be used for medical purposes, often without being part of a physical medical device. While offering benefits like accessibility and improved patient outcomes, SaMD also poses challenges related to privacy, ongoing validation, and compliance. Its lifecycle involves development, testing, approval, launch, and post-market surveillance.
IEC 62304 is the internationally accepted guide for developing safe and effective Medical Device Software. This standard intricately guides developers through essential phases such as development, risk management, verification, validation, configuration control, and maintenance.
Looking For Software as Medical Device Registration Consultation?
Let’s have a word about your project
Read A Guide to SaMD.
Examples of SaMD: SaMD encompasses a wide range of applications, from mobile apps to complex algorithms. Some examples include:
- Mobile apps that track and monitor blood glucose levels in diabetes patients.
- Software that analyzes medical images (such as X-rays or MRIs) to aid in diagnosis.
- Algorithms that process electrocardiogram (ECG) data to detect irregular heart rhythms.
- Apps that offer cognitive behavioral therapy for mental health conditions.
Information About an Update on Compulsory Registration for Class C and D Medical Devices
The Central Drugs Standard Control Organization (CDSCO) has introduced changes to the regulatory Sr. No. framework for Class C and Class D (non-notified) medical devices. Instead of mandatory registration, these devices will now adhere to a licensing system outlined in GSR 102(E) dated 11.02.2020. This transition is effective from October 1, 2023.
Manufacturers and importers intending to obtain licenses for these classes of devices must adhere to the Medical Devices Rules (MDR) 2017. They are required to submit applications through CDSCO’s online portal along with the requisite documentation and fees. For detailed information.
Please refer to the official circular provided.
Read our blog Global Regulations for Software as Medical Device for more details.
List of Class C Software as Medical Device
Take a look at a couple of Class C Software as Medical Device below –
Sr. No. | Device Name | Risk Class |
1. | Coronary Vascular Physiologic Simulation Software | C |
2. | Angiographic Coronary Vascular Physiologic Simulation Software | C |
3. | Diabetic Retinopathy Detection Device | C |
4. | Software For Visualization of Vascular Anatomy and Intravascular Devices | C |
5. | Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer | C |
Take a moment to review the full spectrum of Class C Software as Medical Device outlined here.
Need More Clarity on Licensing Regime of Class C and Class D Software as Medical Device?
Documents Required for CDSCO Manufacturing License of Class C and D Software as Medical Device
Obtaining a CDSCO manufacturing license involves a comprehensive dedication to adherence, encompassing precise facility requirements, systematic procedures, and thorough record-keeping. This steadfast strategy ensures the development of medical devices that consistently meet stringent standards for both quality and safety.
Documents Required for CDSCO Import License of Class C and D Software as Medical Device
Acquiring a CDSCO import license requires obtaining Approval and Free Sale Certificates from well-known international regulatory authorities such as the USA, EU, Japan, Australia, and Canada. These certificates validate adherence to global quality standards and unrestricted market acceptance, underscoring their crucial role in ensuring safety and import excellence.
How Operon Strategist Will Consult You in CDSCO Registration for Software as Medical Device
If you’re seeking to navigate the intricate process of Software as a Medical Device (SaMD) CDSCO licensing, consider collaborating with Operon Strategist. Our expertise of 12 years in the field can guide you through each step, ensuring your SaMD meets all regulatory requirements. From early development stages to post-market surveillance activities, Operon Strategist can provide valuable insights and support. Contact us now!
