Starting a business in the medical device sector in India is a smart decision. The demand for quality medical equipment is growing fast. But before you start selling or importing any medical device in India, you must get approval from CDSCO. This process is called CDSCO Registration in India.
CDSCO stands for Central Drugs Standard Control Organization. It is the national authority that regulates medical devices, drugs, and cosmetics in India. If you are planning to sell, import, or manufacture a medical device in India, you need approval from CDSCO.
Now the big question is – how long does the CDSCO approval take for medical devices? Let’s understand the complete process in simple words.
What is CDSCO Registration in India?
CDSCO Registration in India is the official approval process for medical devices, drugs, and cosmetics. The goal is to make sure that these products are safe and work properly. Whether you are a manufacturer in India or an importer from another country, you need to get permission from the CDSCO before you can start business in India.
What is Medical Device Registration in India?
Medical Device Registration in India is part of the CDSCO process. It applies to products like surgical gloves, X-ray machines, MRI scanners, contact lenses, and even digital thermometers. Earlier, only a few devices were regulated. But now, CDSCO has added many more devices to its list.
There are different categories of medical devices based on the risk level:
Class A – Low risk (e.g., thermometers)
Class B – Low to moderate risk (e.g., blood pressure monitors)
Class C – Moderate to high risk (e.g., infusion pumps)
Class D – High risk (e.g., heart stents)
The time for approval depends on the class of the device.
Steps to Get Medical Device Registration in India
To understand how long it takes, you first need to know the steps involved:
1. Determine the Device Class
First, you must know which class your device belongs to (A, B, C, or D). This step is important because the process and timeline vary depending on the risk category.
2. Appoint an Authorized Indian Agent
If you are a foreign company, you must appoint an authorized agent in India who will act on your behalf during the registration process.
3. Prepare and Submit the Application
You will need to submit Form MD-14 (for importers) or MD-3 (for manufacturers). Along with this form, you must include documents like:
Technical details of the device
ISO 13485 certificate
Free Sale Certificate (for imports)
Device master file
Manufacturing site master file
4. CDSCO Review and Clarification
CDSCO will review your documents. Sometimes they may ask for clarification or extra documents. This can add a few weeks to the timeline.
5. Grant of Registration
If everything is correct, CDSCO will issue a license in Form MD-15 (for importers) or MD-5 (for manufacturers).
How Long Does It Take?
Now let’s talk about the expected timeline for CDSCO approval:
✅ For Class A and Class B Devices (Low-risk)
These are handled by the State Licensing Authorities (SLA). The time is usually:
30 to 60 days if all documents are correct.
✅ For Class C and Class D Devices (High-risk)
These are handled directly by CDSCO. The time taken is longer:
4 to 6 months, depending on the complexity and document quality.
✅ For Imported Devices
Importing medical devices takes more time because:
More documents are needed.
CDSCO checks the Free Sale Certificate and country of origin details.
In such cases, approval may take:
6 to 9 months
Tips to Speed Up the Process
Submit Correct Documents: One of the biggest delays happens because of missing or wrong documents. Double-check everything before submission.
Hire a Professional Consultant: If you're not sure about the process, hire someone who knows CDSCO rules well. This can save time and avoid rejections.
Respond Quickly to Queries: If CDSCO asks for clarification, respond quickly with complete answers.
What About Cosmetic License Registration and Drug License Registration?
CDSCO doesn’t just handle medical devices. It also approves cosmetics and drugs. These licenses are also important if you're entering the health and wellness business.
✅ Cosmetic License Registration
If you're importing or manufacturing cosmetics like skincare or hair care products, you need a Cosmetic License for manufacturing. This takes:
Around 2 to 3 months if all documents are in order.
✅ Drug License Registration
If you're dealing with medicines, vaccines, or related items, you need a Drug License Registration. This is a more detailed process and may take:
3 to 6 months, depending on the product type.
Both licenses require approval from CDSCO and sometimes the state drug authorities as well.
Conclusion
CDSCO Registration in India is a must for selling medical devices, drugs, or cosmetics in the country. The timeline depends on the type and class of your product. For Medical Device Registration in India, it can take anywhere from 30 days to 9 months, depending on the complexity and quality of the documents.
If you're also looking into Cosmetic License Registration or Drug License Registration, the time will vary, but it’s always best to start early and prepare well.
Getting approval from CDSCO may seem like a long road, but with the right support and planning, it can be a smooth journey. Whether you're a manufacturer or importer, being compliant with CDSCO rules ensures that your products are safe, trusted, and ready for the Indian market.
Need help with CDSCO, Cosmetic, or Drug License Registration?
Get in touch with our CorpBiz expert team to simplify your approval process and get your product to market faster!
