CDSCO Registration for Software as Medical Device (SaMD)
The quality of software in medical devices is very important because a failure in medical device software can have fatal consequences for patients. All software that intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device are regulated under Medical Device Rules, 2017.
If you are a developer or importing software to be used for medical purposes, then you must need a CDSCO Medical Device Registration for the software. Below is the The Central Drugs Standard Control Organization (CDSCO) published a list of software as medical device.
Software as a Medical Device (SaMD) Definition: What is SaMD?
Software as a Medical Device (SaMD) is software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. SaMD is a medical device and includes in-vitro diagnostic (IVD) medical devices.
SaMD is capable of running on general purpose (non-medical purpose) computing platforms, such as smartphones, tablets, and computers. SaMD is not necessary for a hardware medical device to achieve its intended medical purpose.
Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device. SaMD may be used in combination with other products, including medical devices, and may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software.
Licensing authorities for Registration for Software as Medical Device (SaMD) in India
The CDSCO is the licensing authority for Class C and Class D Software as Medical Device (SaMD) and the State Licensing Authority is the licensing authority for Class A and Class B for Software as Medical Device (SaMD) in India.
Benefits of CDSCO Medical Device License
A CDSCO medical device license is not just a requirement for manufacturers and suppliers of medical devices. It also offers several benefits to healthcare providers and patients.
- For healthcare providers, a CDSCO license provides assurance that the medical devices they are using are safe and effective. This helps them to provide better quality care to their patients. It also protects them from legal liability in case of any adverse events.
- For patients, a CDSCO license is a guarantee that the medical devices they are receiving are of the highest quality. This helps to reduce the risk of complications and ensures that they have the best possible chance of recovery.
- In addition to these benefits, a CDSCO medical device license also helps to promote transparency and accountability in the healthcare sector. It ensures that all medical devices on the market meet the same high standards of safety and efficacy.
- Overall, a CDSCO medical device license is an important safeguard for both healthcare providers and patients. It helps to ensure that high-quality medical devices are available to everyone in India.
List of “Class A” Software as Medical Device (SaMD)
- Continuous Glucose Monitor Retrospective Data Analysis Software
- Ataxiagraph With Interpretive Software
List of “Class B” Software as Medical Device (SaMD)
- Continuous Glucose Monitor Secondary Display Software
- Insulin Pump Secondary Display Software
- Multivariate Vital Signs Index Software
- Electrocardiograph Software for home use
- Photoplethysmograph Analysis Software for home use
- Diagnostic Software, K- Nearest Neighbor Algorithm, Autoimmune Disease
- Colon Computed Tomography System, Computer Aided Detection Software
- Lung Computed Tomography System, Computer- Aided Detection Software
- Chest X-Ray Computer Aided Detection Software
- Radiological Computer Assisted Detection/diagnosis Software For Fracture
- X-Ray Angiographic Imaging-Based Coronary Vascular Simulation Software Device
- Automated Radiological Image Processing Software
- Image Acquisition and/or Optimization Guided By Artificial Intelligence
- Software for public thoracic and abdominal health screening diagnostic X- ray system
- Software for visual evoked response stimulator
- Software for auditory evoked response stimulator
- Software for pulmonary exercise stress monitoring system
- Software for ECG recorder with real-time analysis
- Software for film-recorded digital radiography
- Software for dye dilution cardiac output calculator
- Software for urodynamic measurement system
- Software for vestibular function caloric stimulator
- Supporting software for external fixators treatment plan
- Diagnostic supporting software for diabetes
- Quantitative calculation software for IGC test
- Analyzing software for hemodynamics or cardiac function
- Supporting software for root canal treatment
- Chairside dental CAD/CAM unit
- Software for using with mammography- combined diagnostic X- ray system
List of “Class C” Software as Medical Device (SaMD)
- Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
- Coronary Vascular Physiologic Simulation Software
- Angiographic Coronary Vascular Physiologic Simulation Software
- Software For Visualization Of Vascular Anatomy And Intravascular Devices
- Orthodontic Software
- Dental Abutment Design Software For Dental Laboratory
- Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
- Normalizing Quantitative Electroencephalograph Software
- Index- Generating Electroencepha lograph Software
- Source Localization Software For Electroencepha lograph Or Magnetoencep halograph
- Automatic Event Detection Software For Polysomnograp h With Electroencepha lograph
- Automatic Event Detection Software For Full-Montage Electroencepha lograph
- Computerized Cognitive Assessment Aid For Concussion
- Computerized Behavioral Therapy Device For Psychiatric Disorders
- Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
- Device, Fertility Diagnostic, Contraceptive, Software Application
- Diabetic Retinopathy Detection Device
- Computer- Assisted Diagnostic Software For Lesions Suspicious For Cancer
- Burn Resuscitation Decision Support Software
- Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
- Software for peritoneal dialysis treatment
- Software for radiation planning
- Software for radiotherapy QAQC planning
- Software for ophthalmic surgery treatment planning
- Software for active implanted device control
- Information collating software for radiotherapy
- Software for gene variants analysis (for cancer genome profiling)
- Supporting software for differential diagnosis with endoscopic imaging
- Ventilator, software
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CDSCO Registration for Software as Medical Device (SaMD) Requirement:
- To register Class A and Class B Software as Medical Device (SaMD) in India, you must obtain the MD 5 License from the State Licensing Authority.
- To register Class C and Class D Software as Medical Device (SaMD) in India, you must obtain the MD 9 License from the Central Drugs Standard Control Organization (CDSCO).
- To import Software as Medical Device (SaMD) into India, you must obtain the MD 15 Import Registration from the CDSCO.
Requirements for Registration and Import of Software as Medical Device (SaMD) in India
License Fee for CDSCO Registration for Software as Medical Device (SaMD) in India
- Class A or Class B: ₹ 5,000/- for license, ₹ 500/- for each distinct software.
- Class C or Class D: ₹ 50,000/- for license, ₹ 1,000/- for each distinct software.
Validity of CDSCO Registration for Software as Medical Device (SaMD) License in India
The CDSCO Registration for Software as Medical Device (SaMD) is valid indefinitely, as long as the retention fee is paid every 5 years.
How to Apply Online for CDSCO Registration for Software as Medical Device (SaMD) in India
- Step 1: Enrol your organization on CDSCO’s SUGAM Portal.
- Step 2: Fill in the respective applications and submit them through CDSCO’s online SUGAM Portal.
- Step 3: Upload the necessary documents and make the required payment.
- Step 4: Your application will be scrutinized by the CDSCO Team. If it meets the requirements, it will proceed to a quality management system compliance audit.
- Step 5: The Team will conduct an audit at your premises. If any Non-Conformance (NC) is identified, you will be required to submit an NC closure report.
- Step 6: Once all the conditions are met, CDSCO will grant the license.
Deadline for Obtaining Registration for Software as Medical Device (SaMD) in India
The deadline for obtaining Registration for Software as Medical Device (SaMD) in India is October 1, 2022 for Class A and Class B software, and September 30, 2023 for Class C and Class D software.
List of Documents for Obtaining CDSCO Registration for Software as Medical Device (SaMD) in India
- Organization identity proof: This could be the Memorandum of Association, List of Directors or Partners, UDYAM Aadhar, or PAN card.
- Sale Deed / Rent Deed of the Premises: This document proves that you have legal ownership of the premises where you will be manufacturing the medical devices.
- Plant or Site Master File: This file contains information about the layout of your manufacturing facility, as well as the equipment and processes you will be using.
- Building Layout with Dimension: This is a detailed drawing of your manufacturing facility, showing the dimensions of each room and the location of all equipment.
- ISO 13485 Certificate and Previous Audit Reports: This certificate shows that your manufacturing facility meets international standards for quality management systems.
- Competent Technical Staff for Manufacturing and Testing of Devices: You must have a team of qualified and experienced staff who can manufacture and test your medical devices.
- Device Master File: This file contains detailed information about each software you will be developing, including its design, manufacturing process, and testing procedures, software validation.
- Test License, if any: If you need a license to test your software, you must obtain it before you can start developing it.
- Compliance with the environmental requirements: You must comply with all applicable environmental regulations, such as those related to cleanrooms for manufacturing the devices.
- Certificate of Analysis: This certificate shows that the software you developed meets the required quality standards.