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- CDSCO License for Medical Devices for manufacturing, importing, or selling medical devices in India.
- Medical devices are regulated under the Medical Device Rules, 2017.
- Devices are classified into Class A, B, C, and D based on risk level.
- Approval is issued by CDSCO or State Licensing Authority, depending on device class
- Proper documentation and compliance can speed up the approval process.
Introduction | CDSCO License for Medical Devices
If you want to manufacture, import, or sell medical devices in India, getting a CDSCO certificate is compulsory. The Central Drugs Standard Control Organization (CDSCO) regulates medical devices to ensure they are safe, effective, and meet quality standards.
India’s medical device assistance is growing fleetly. With this growth, the government has made regulations stricter to cover cases and insure product quality. That’s why understanding the CDSCO instrument process is veritably important for manufacturers, importers, and distributors.
In this companion, we will explain everything in simple and easy language — what a CDSCO instrument is, why it’s needed, the complete step- by- step process, needed documents, and how a professional adviser like an Diligence Certification can help you.
What is a CDSCO License for Medical Devices?
CDSCO License for Medical Devices Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority under the Ministry of Health & Family Welfare, Government of India.
CDSCO controls the approval of:
- Medical devices
- Drugs
- Cosmetics
- Clinical trials
Under the Medical Device Rules, 2017, all notified medical devices must be registered and approved before being sold in India.
Key Points About CDSCO Certificate
- It’s a government blessing license.
- It ensures the product meets quality and safety norms.
- It’s obligatory for both Indian manufacturers and foreign importers.
- Different classes of bias bear different situations of blessing.
- Without CDSCO blessing, dealing with medical bias is illegal in India.
Classification of Medical Devices in India
Medical devices are divided into four classes based on risk level:
| Class | Risk Level | Example |
| Class A | Low Risk | Surgical dressings, thermometers |
| Class B | Low-Moderate Risk | BP monitor, suction equipment |
| Class C | Moderate-High Risk | Ventilators |
| Class D | High Risk | Heart valves, implantable devices |
Higher risk devices require more documentation and stricter evaluation.
Why is CDSCO License for Medical Devices Required?
CDSCO certification is not just a legal requirement — it protects public health and builds trust.
Key Reasons Why CDSCO Certificate is Important
- Legal Compliance Selling unrecorded medical bias can affect in heavy penalties and product seizure.
- Case Safety Ensures bias meets quality and safety norms.
- Market Access You can not sell or import bias without blessing.
- Business Credibility Government blessing increases trust among hospitals and distributors.
- Export openings numerous countries prefer suppliers with strong nonsupervisory compliance.
Step-by-Step Process to CDSCO License for Medical Devices
Step 1: Determine Device Classification
First, identify whether your product falls under Class A, B, C, or D.
Classification depends on:
- Intended use
- Risk involved
- Duration of contact with the body
Correct classification is very important because it decides the approval pathway.
Step 2: Appoint Authorized Indian Agent (For Foreign Manufacturers)
If you are a foreign manufacturer, you must appoint an Authorized Indian Agent who will handle communication with CDSCO.
Step 3: Register on CDSCO Online Portal
Applications are submitted online through the CDSCO SUGAM portal.
You need:
- Company details
- Manufacturing site details
- Device details
- Technical documents
Step 4: Prepare Required Documents
Documentation is the most important part of the process.
Common documents required:
- Device Master File (DMF)
- Plant Master File (PMF)
- ISO 13485 Certificate
- Free Sale Certificate (for import)
- CE certificate (if available)
- Test reports
- Undertaking & declarations
- Power of Attorney (for importers)
Incomplete documents can delay approval.
Step 5: Submission of Application
Applications are submitted in different forms depending on device class:
- Class A & B – State Licensing Authority
- Class C & D – CDSCO Head Office
After submission, government fees must be paid.
Step 6: Technical Review
Authorities review:
- Safety data
- Clinical evaluation (if required)
- Manufacturing quality system
- Risk analysis
For higher-risk devices (Class C & D), expert committee review may be required.
Step 7: Inspection (If Required)
For manufacturing licenses, inspection of the manufacturing facility may be conducted to verify compliance with ISO 13485 and Medical Device Rules.
Step 8: Grant of CDSCO Certificate
If everything is satisfactory, the authority grants:
- Manufacturing License OR
- Import License
Now you can legally sell your medical device in India.
Timeline for CDSCO Medical Device Approval
Approximate timelines:
- Class A & B: 3–6 months
- Class C & D: 6–9 months
Timelines may vary depending on documentation quality and authority workload.
Common Mistakes to Avoid
- Wrong device classification
- Incomplete documentation
- Missing ISO 13485 certification
- Incorrect labeling details
- Not responding to queries on time
Avoiding these mistakes can save months of delay.
Why Choose Diligence Certification for CDSCO Registration?
Getting a CDSCO blessing can be complex and specialized. That’s why numerous companies choose professional advisers like Diligence Certifications.
Benefits of Choosing Diligence Certification
- Expert Guidance Endured nonsupervisory professionals handle your case.
- Correct Bracket Support Prevents operation rejection.
- Complete Documentation Preparation DMF & PMF prepared professionally.
- Faster blessing Process Proper form reduces detainments.
- End- to- End Support From operation to license blessing.
- Affordable and Transparent freights No retired charges.
- Post-Approval Compliance Support Help with renewals and updates.
Cost of CDSCO Medical Device Registration
The cost depends on:
- Device class
- Whether manufacturing or import
- Number of devices
- Government fees
- Consultant charges
For exact cost estimation, professional consultation is recommended.
Conclusion
Getting a CDSCO instrument for medical bias in India is an obligatory and important process. It ensures your product meets safety and quality norms while allowing you to fairly vend in the Indian request.
Although the process may feel complicated, understanding the way makes it easier
- Identify bracket
- Prepare documents
- Submit operation
- Respond to queries
- Get blessing
Working with experts like a Diligence Certification can make the entire process briskly and more dependable, If you want a smooth and hassle-free experience.
With proper planning and correct attestation, you can successfully gain your CDSCO instrument and grow your medical device business in India.
Frequently Asked Questions (FAQs)
Is CDSCO registration mandatory for all medical devices?
Yes, all notified medical devices require CDSCO approval before sale in India.
How long does it take to get CDSCO certificate?
It usually takes 3–9 months depending on device class.
What is the validity of CDSCO medical device license?
The license is generally valid perpetually, subject to retention fee payment.
Is ISO 13485 mandatory for CDSCO approval?
Yes, ISO 13485 certification is required for manufacturing medical devices.
Can a foreign company apply directly for CDSCO registration?
No, foreign companies must appoint an Authorized Indian Agent.
What happens if I sell devices without CDSCO approval?
You may face penalties, product seizure, and legal action.
What is the difference between Class A and Class D devices?
Class A is low risk, while Class D is high risk and requires strict evaluation.
Can CDSCO reject my application?
Yes, if documentation is incomplete or incorrect.
Do I need clinical data for all devices?
Not for all, but high-risk devices may require clinical evaluation.
Can a consultant speed up CDSCO approval?
A professional consultant can reduce errors and help avoid delays.
