CDSCO Registration For Software as Medical Device (SaMD)

If you want to develop or import software for medical purposes, you must get a CDSCO Registration for software as medical device(SaMD). Ensuring the quality of the software used in medical devices is essential because if any failure occurs in medical device software, it can have fatal consequences for patients. All software used for one or more medical purposes without being a part of a hardware medical device is regulated under MD Rules, 2017.

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What Is Software as a Medical Device (SaMD)?

Software as a Medical Device (SaMD) is software for one or more medical purposes that perform medical purposes without being a part of a hardware medical device. SaMD is a medical device that includes in-vitro diagnostic (IVD) medical devices. SaMD can run on general (non-medical) computing platforms, like smartphones, tablets, and computers.

Licensing Authorities For Software as Medical Device (SaMD)

The licensing authority for Class C and Class D Software as Medical Device (SaMD) is the Central Drugs Standard Control Organization (CDSCO), and for Class A and Class B Software as Medical Device (SaMD) is the State Licensing Authority in India.

List Of CDSCO Registration For Software as Medical Device (SaMD)

If you are willing to check which software requires CDSCO registration for software as medical device, then you must check the mentioned list. In this list, you will get to know about the categories of medical device classes and software that falls under them. Through this compiled list, you will get to know about which software you must apply for the CDSCO registration In India. The list fo software as follows:

Class A Software as Medical Devices For CDSCO License

In the list of Class A software, the medical devices are as follows:

Continuous Glucose Monitor Retrospective Data Analysis Software
Ataxiagraph With Interpretive Software

Class B Software as Medical Device For CDSCO Certificate

Check the below-mentioned list through which you can simply apply for the CDSCO registration for Software as medical devices that fall under the class B category. The software as follows:

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
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 or diagnosis Software For Fracture
X-ray angiographic Imaging-Based Coronary Vascular Simulation Software Device
Automated Radiological Image Processing Software
Image Acquisition and 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 use with mammography- combined diagnostic X-ray system

Class C Software As Medical Devices For CDSCO Registration

Explore the Class C Medical device Software to apply for CDSCO registration to enter the medical market without facing any kind of custom barriers. The list of products as follows:

Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
Coronary Vascular Physiologic Simulation Software
Angiographic Coronary Vascular Physiologic Simulation Software
Orthodontic Software
Dental Abutment Design Software For Dental Laboratory
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
Normalizing Quantitative Electroencephalograph Software
Index- Generating Electroencepha holograph Software
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
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 for peritoneal dialysis treatment
Software for radiation planning
Software for radiotherapy QAQC planniAeshmeetang
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)
Ventilator, software

If you are dealing in any other item related to the medical industry, then you must go with expert guidance. They will determine the product first and tell you which category your product falls. Afterwards, you can seamlessly apply for the CDSCO license registration to import and manufacture medical devices.

Licensing Requirements For (SaMD) CDSCO Registration Of Software as Medical Device

As you are willing to apply for the medical device registration as a software, you must go through the license requirement details. Because the license varies according to the category. For each category, you have to apply for a particular license that is mentioned below:

Class A And Class B SaMD – Get the MD 5 License from the State Licensing Authority.
Class C And Class D SaMD – Obtain the MD 9 License from the Central Drugs Standard Control Organization (CDSCO)
Importing SaMD into India -Obtain the MD 15 Import Registration from the CDSCO

Which Form Required For Registration & Import Of Software as Medical Device?

For the application of the CDSCO registration of software in the medical industry, you have to fill form as per the CDSCO guidelines. The form required for are:

Form MD 5 for Medical Device Class A and Class B Medical device software (License from the State Licensing Authority)
Form MD 9 CDSCO license for MD Class C and Class D Medical equipment software
Form MD 15 Import License from the CDSCO for Import

Procedure To Apply CDSCO Registration For Software as Medical Device Online

To understand the process of applying for the license, follow the mentioned steps. If you have any difficulty with the above steps, you can directly connect with our expert. They will explain each step and make your procedure easier. The steps for the application are as follows:

Step 1: You must enrol on CDSCO’s SUGAM Portal in your organisation.

Step 2: Fill out the respective forms of applications and submit them via the CDSCO’s online SUGAM Portal.

Step 3: Upload all the required documents and then make payment.

Step 4: The CDSCO Team will scrutinize your application. If it meets all the requirements of CDSCO, it will proceed to a quality management system compliance audit.

Step 5: The Team will conduct an audit at your manufacturing premises. You must submit an NC closure report if the team identifies any Non-Conformance (NC).

Step 6: Once all the requirements are met, CDSCO will grant the manufacturing license

Documents Required for CDSCO Registration Of Software as Medical Device (SaMD)

To obtain the CDSCO registration of software as medical device you must attach the following documents as per the guidelines. Further you you find any addition document that is related to your product then we recommend you to consult with the professional first:

Organization identity proof
Sale Deed or Rent Deed of the Premises
Plant or Site Master File
Building Layout with Dimension
ISO 13485 Certificate and Previous Audit Reports
Competent Technical Staff for Manufacturing and Testing of Devices
Device Master File
Test License, if any
Compliance with the environmental requirements
Certificate of Analysis

How Much Does CDSCO License For Software Cost?

Its a tricky question for the applicant because the fee of the license varies as per the class of the product. For the exact information, you must consult with the Medical device registration consultancy. They will guide you about the prices and other necessary documents also.

On the Other Hand, A manufacturing license costs ₹ 5,000/- approx for Class A or Class B and ₹ 500/- approx for each distinct software. A manufacturing license costs ₹ 50,000/- approx for Class C or Class D and ₹ 1,000/- for each software approximately.

Also Check these Latest Blogs:-

What Is The Validity Of Software CDSCO License As Medical Device?

The manufacturing Licenses of Software as Medical Devices (SaMD) are valid indefinitely; the renewal fee must be paid every 5 years.

Is Software An Active Medical Device?

Software that meets the definition of a medical device is considered an active medical device.

What Is The Software Standard For Medical Devices?

The software standard for medical devices is an IEC 62304.

What Are The Different Types Of Medical Device Software?

Two types of medical device software are different in terms of technology and development Software such as Medical Devices (SaMD) and embedded systems.