Software as a Medical Device (SaMDs) are now playing critical roles in patient care, diagnostics, and treatment decisions. Unlike general health apps, SaMD directly influences clinical outcomes, making oversight essential to ensure safety, efficacy, and reliability. In India, CDSCO regulates all SaMDs entering the Indian market. CDSCO regulations establish clear classification, licensing, and documentation requirements that help prevent risks, such as inaccurate diagnoses and cybersecurity breaches. By enforcing compliance with international standards, like ISO 13485, CDSCO safeguards public health. Additionally, it helps build trust among healthcare providers and patients. Multiple licenses are in place for SaMD. Hence, the CDSCO SaMD license application process can be confusing. In this blog, we have presented in details the different CDSCO licensing pathways for SaMD. This blog will help you choose the correct CDSCO SaMD license for your product.
CDSCO SaMD classification system
To understand the different CDSCO licensing pathways for SaMD, you need to first understand the CDSCO SaMD classification system. CDSCO has classified medical devices into four classes based on the associated risk level. This classification system has been developed to simplify the CDSCO medical device license application process. The CDSCO medical device class will determine the CDSCO license required and the application process. CDSCO has developed a similar risk-based classification system for SaMDs. The CDSCO SaMD class will determine the CDSCO license required. We have presented the CDSCO SaMD classification system.
- CDSCO Class A SaMD: CDSCO Class A SaMDs are low risk medical devices. The Class A software does not directly interfere with patient data. It is a software that retrospectively analyses pre-recorded clinical data of patients. Examples: Continuous glucose monitor retrospective data analysis software. Ataxiagraph with interpretive software
- CDSCO Class B SaMD: CDSCO Class B SaMDs are low to moderate risk SaMDs. The Class B software generates real time patient information based on patient’s parameters. Examples: Software for pulmonary exercise stress monitoring system, Software for ECG recorder with real-time analysis, Software for visual evoked response stimulator, Software for auditory evoked response stimulator, Analyzing software for hemodynamics or cardiac function, Supporting software for root canal treatment
- CDSCO Class C SaMD: CDSCO Class C SaMDs are moderate to high-risk devices. The Class C software can be used to diagnose diseases and analyse patient’s physiological and physical activity. Insulin pump therapy adjustment calculator for healthcare professionals, 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, Coronary vascular physiologic simulation software
- CDSCO Class D SaMD: CDSCO Class D SaMDs are high risk devices. CDSCO has not yet classified any software as high risk.
Different CDSCO licensing pathways for SaMD
Different classes of SaMD require different CDSCO licenses. We have listed the different types of licenses required to manufacture SaMD. Additionally, we have mentioned the CDSCO license required to import SaMD into India.
CDSCO license for manufacturing SaMD in India
- CDSCO MD 5 license: To manufacture Class A and Class B SaMDs in India, CDSCO MD 5 license must be secured from the state licensing authority. The application for CDSCO MD5 license has to be filed on Form MD 3. The license to manufacture Class A and Class B SaMDs will be granted on MD5 license.
- CDSCO MD 9 license: To manufacture Class C and Class D SaMDs in India, CDSCO MD 9 license must be secured from the central licensing authority. The application for CDSCO MD9 license has to be filed on Form MD 7. The license to manufacture Class C and Class D SaMDs will be granted on MD9 license.
CDSCO license for importing SaMD into India
- CDSCO MD 15: To import SaMDs into India, CDSCO MD 15 has to be secured from the Central Drugs Standard Control Organization. The application for CDSCO MD15 license has to be filed on Form MD 14. The license to import SaMDs will be granted on MD15 license.
Validity of CDSCO license for SaMD in India
The CDSCO license for SaMD remains valid indefinitely. However, a license retention fee has to be paid every 5 years to maintain the license validity.
Documents required for securing CDSCO license for SaMD in India
An overview of the documents required for securing CDSCO license for SaMD in India.
- Covering letter
- Organization identity proof, such as memorandum of association, list of directors or partners, UDYAM Aadhar, or PAN card.
- Sale deed/rent deed of the premises proving the legal ownership of the medical device manufacturing facility.
- Facility layout with dimension. A detailed drawing of the medical device manufacturing facility with the dimensions of each room and the location of all equipment.
- ISO 13485 certificate
- Plant master file containing information about the layout of the facility.
- Device master file contains detailed information about the software, including its design, manufacturing process, testing procedures, and validation
- Documents demonstrating compliance with the environmental requirements
- Certificate of analysis demonstrating the software meets the required quality standards
- Test license for the SaMD, if required
- Details and qualification of technical staff who will manufacture and test the medical devices
- Free sale certificate for CDSCO SaMD import license
We have provided an overview of the documents required for securing CDSCO SaMD license in India. Feel free to get in touch for a detailed list of documents required for CDSCO SaMD license application. Additionally, we will help prepare and compile the documents per CDSCO guidelines. Our document preparation service will ensure all the documents are prepared per the CDSCO requirements.
How to apply for CDSCO licensing pathways for SaMD?
- First step is to check whether the software qualifies as a medical device
- Check the CDSCO class for the SaMD, as this will determine the application form and requirements.
- Login or create an account on CDSCO’s SUGAM Portal.
- Fill in the respective application forms
- Compile and upload the necessary supporting documents. Additionally, pay the required fees.
- The application will be reviewed and the documents will be verified by the regulatory authorities. Furthermore, the regulatory authorities may conduct an audit.
- Once the regulatory officials are satisfied, the application will be approved. Then, the CDSCO license for manufacturing or importing the SaMD mentioned in the license will be granted.
Pharmadocx Consultants team will help you easily navigate through the different CDSCO licensing pathways for SaMD
In this blog, we have detailed the different CDSCO licensing pathways for SaMD to help you understand which CDSCO SaMD license is applicable for your product. CDSCO SaMD license application process can be a tricky task. The process requires knowledge of the CDSCO regulatory guidelines. CDSCO SaMD license application process is cumbersome requiring extensive document preparation and CDSCO query response, if needed. Feel free to contact us at [email protected] or call/Whatsapp on 9996859227 for a smooth CDSCO SaMD license application journey. We have extensive expertise and knowledge of the CDSCO medical device license application process. We will be more than happy to help you easily obtain CDSCO license for Software as a Medical Device in India. Our holistic support covers everything from document preparation to application submission. Additionally, we provide CDSCO query response support. Moreover, our support does not end with license application. We provide continuous compliance support as well.
