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Medical Device Registration Online in India

Q: What is the difference between a Device Master File (DMF) and a Plant Master File (PMF)?

The Device Master File (DMF) contains all technical details about the medical device, such as design, materials, and safety data. The Plant Master File (PMF) describes the manufacturing site, including equipment, quality controls, and processes. Both are needed for registration to prove device safety and manufacturing quality.

Q: Can I have more than one Indian Authorized Agent for the same device?

No, you cannot appoint more than one Indian Authorized Agent (IAA) for the same medical device. CDSCO requires only one authorized agent to represent a foreign manufacturer in India. This helps avoid confusion and ensures clear communication with regulators.

Q: What is a "predicate device" and why is it important?

A predicate device is an already approved medical device similar to yours. It is important because CDSCO may use it to compare safety and performance. Showing your device is as safe as a predicate device can simplify approval and reduce the need for clinical trials.

Q: Do I need to conduct clinical trials in India for my device?

Not always. If your device is approved in countries recognized by CDSCO and has a strong predicate device in India, clinical trials may not be required. However, if CDSCO needs more evidence, they may ask for local clinical trials or data review by an expert panel.

Q: Is a BIS certification also required for my medical device?

BIS certification is only required for certain medical devices that fall under the Bureau of Indian Standards’ scope. Most medical devices need CDSCO registration, but if your device is covered by BIS standards, you must get BIS certification as well.

Q: How do I register software as a medical device (SaMD)?

Software used for medical purposes is treated as a medical device if it meets CDSCO’s definition. You must classify the software based on risk and follow the same registration process as hardware devices. Prepare technical documents, safety data, and comply with quality standards.

Q: My application was rejected. What are my options?

If your application is rejected, you can appeal the decision or submit additional data to address CDSCO’s concerns. You may also reapply after correcting errors. It’s important to carefully review the rejection reasons and respond promptly to improve chances of approval.

Q: Can I apply for multiple devices in one application?

No. CDSCO regulations require a separate application for each individual medical device or device family to ensure a thorough and accurate review.

Q: How long is a medical device registration valid?

A medical device registration or license is valid for five years from the date of issue. You must apply for renewal before expiry to continue legally manufacturing or importing the device.

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Frequently Asked Questions (FAQs)

Do I need a license for a Class A medical device?

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Yes, you need a license for Class A medical devices in India. These are low-risk products but still require registration and a manufacturing or import license from CDSCO or the State Licensing Authority. Selling without a license is illegal and can lead to penalties.

What is the difference between a Device Master File (DMF) and a Plant Master File (PMF)?

Can I have more than one Indian Authorized Agent for the same device?

What is a "predicate device" and why is it important?

Do I need to conduct clinical trials in India for my device?

Is a BIS certification also required for my medical device?

How do I register software as a medical device (SaMD)?

My application was rejected. What are my options?

Can I apply for multiple devices in one application?

How long is a medical device registration valid?

What languages are accepted for registration documents?

Are there any fees for registration renewal?

Can I sell my device immediately after registration?

What if my device classification changes during review?

Is ISO 13485 certification mandatory for registration?

Why Choose RegisterKaro for the Medical Device Registration Service?

RegisterKaro offers a streamlined approach to medical device registration, ensuring full compliance.

Expert Guidance from Start to Finish: Our team provides in-depth knowledge of the CDSCO guidelines, ensuring that each step of the registration process is handled efficiently and accurately.
Error-Free Documentation and Submission: All required documentation is meticulously prepared and reviewed, reducing the chances of errors that could delay approval.
Direct Liaison with CDSCO for Faster Query Resolution: We communicate directly with CDSCO on your behalf. This helps resolve queries quickly.
Transparent Pricing and Clear Timelines: No hidden fees or unexpected costs. You will receive a clear breakdown of the pricing structure along with a timeline, so you always know what to expect.

Why Choose RegisterKaro for the Medical Device Registration Service?

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