If you are planning to enter the Indian healthcare market with your medical device approval, many manufacturers are confused about whether US FDA approval is sufficient or CDSCO approval is mandatory. It is important to understand what regulatory approvals you will need. This guide will help you understand the differences, regulatory requirements, and why CDSCO registration is necessary to enter the Indian market.
What is CDSCO?
The CDSCO (Central Drugs Standard Control Organization) regulatory process is mandatory if you want to sell or distribute a medical device approval in India. CDSCO works under the Ministry of Health and Family Welfare and is responsible for
- CDSCO guarantees import and manufacturing licenses.
- CSDCO ensures device safety and quality.
- CDSCO keeps track of how the product performs in the real world after it is sold on the market.
What is the FDA?
The FDA is a federal agency under the U.S. Department of Health and Human Services. It stands for the U.S. Food and Drug Administration.
What are the Roles of the FDA?
The FDA is responsible for protecting public health and also regulating safety, quality, and effectiveness in the United States.
- Food
- Human and veterinary drugs
- Vaccines and biologics
- Medical Devices
- Cosmetics
- Dietary supplements
- Tobacco products
Why FDA Matters for Your Medical Device Approval?
The FDA only for the United States market for regulates medical devices approval. Its approval makes sure devices meet U.S. safety and Performance standards.
- Approving new drugs and medical devices
- Inspecting manufacturing safety
- Issuing recalls if a product is Unsafe
- Setting labelling and packaging standards
Why FDA Approval Matters?
You must get FDA approval if you’re planning to sell a drug or medical device in the U.S. They make sure the product is
- Safe to use
- Effective to use the reason it was made
- Manufactured under quality standards
CDSCO vs FDA – Which One Do You Need For India?
If you’re entering the Indian Market, you need to obtain regulatory approval from the CDSCO because it is mandatory in India. FDA approval is essential for selling medical devices in the United States.
| S.No. | Feature | CDSCO | FDA |
|---|---|---|---|
| 1. | Required for | Selling medical devices in India | It helps speed up the CDSCO approval process |
| 2. | Approval Mandatory? | Yes, for all notified devices | Not mandatory |
| 3. | Regulatory Portal | Sugam Portal | It does not operate a regulatory portal for India. |
| 4. | Risk Classification | Class A, B, C, D (based on risk) | The FDA risk classification system is used only for the U.S. market. |
| 5. | Foreign Manufacturer Requirement | Must appoint an Authorized Indian Agent | It is not required in India |
| 6. | Use of Approval in Other Countries | Recognized Only in India | Recognized only in the U.S |
| 7. | Approval Timeline | Varies by class | Only relevant in the U.S market |
Why CDSCO Approval Matters In India?
CDSCO has set guidelines for Medical device approval in India. These are current guidelines:
The registration process involves:
- Appointing an Authorized Indian Agent (for foreign manufacturers)
- Submitting a Device Master File (DMF)
- Applying through the CDSCO online portal (Sugam)
- Getting a Registration Certificate and/or Import License
Skipping this process can lead to:
- Customs rejections
- Legal penalties
- Business losses
Why FDA Approval Doesn’t Replace CDSCO Compliance in India?
If you’re a global manufacturer, FDA approval is an important step in the regulatory process. It proves that your medical device has met high safety and quality standards in the U.S. market. But if you’re now focused on India, FDA approval by itself does not fulfill Indian regulatory requirements. Even if you already have FDA approval, you still have to follow CDSCO’s full process. Some of your FDA documents can help with test results or safety studies. But they do not accelerate or bypass the CDSCO process.
Think of it this way: FDA approval is helpful, but CDSCO still wants to review your device based on Indian regulatory standards. The rules, risk classification (Class A to D), and approval workflows under CDSCO are designed to match the local healthcare infrastructure, population needs, and quality expectations. If your product is already trusted abroad, CDSCO approval can result in customs clearance issues, fines, or blocked sales. If you want to sell your device in India legally and successfully. So, while FDA approval can give your application a strong foundation.
How Can ELT Corporate Will Help You?
We provide complete assistance for CDSCO approval, from device classification & regulatory strategy, authorized Indian agent service, technical documentation preparation, Sugam portal application, and post-market compliance & renewals.
If you’re not sure where to start, we can simplify the process and ensure compliance in the form of professional support.
Want Help Registering Your Medical Device in India?
Visit medicaldeviceregistration.com
Mobile: 9891998002
Gmail: Info@medicaldeviceregistration.com
We simplify CDSCO registration for global manufacturers.
IS Approval Valid for Selling Medical Devices in India?
No, FDA approval is valid only for the U.S. market. If you want to sell your medical device in India, you must obtain CDSCO approval, regardless of your FDA status.
Do I Need Both CDSCO and FDA Approval?
Only if you’re selling in both India and the U.S., each country has its own regulatory system. For India, CDSCO approval is mandatory. For the U.S., FDA approval is required.
What is the Sugam Portal in CDSCO Registration?
Sugam is the official online portal to manage applications, licenses, and communications for medical device approvals used by the CDSCO.
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