End-to-end support for CDSCO MD-15 import licence — documentation, SUGAM filing, queries and post-approval compliance.
The medical device import license registration under CDSCO in India is very necessary for manufacturers. To enter the Indian market, manufacturers have to fulfil the standards of quality and efficiency to import into India. You are only allowed to import medical devices when you have a medical device importer license under CDSCO.
In India, products such as cosmetics, drugs, medical devices and IVDs are regulated under the provisions of the Drugs and Cosmetics Act, 1940. So it is necessary to obtain a medical device importer registration under CDSCO for the manufacturing, distribution, sale and import of these commodities.
- MD-14Application of Import License
- MD-15Import License Issued by CDSCO
- MD-42Sales & Distribution License
What is CDSCO?
The full form of CDSCO is the Central Drugs Standard Control Organisation. CDSCO is the national authority responsible for the approval and regulation of pharmaceuticals, medical devices and cosmetics in India. Its aim is to confirm that the products available in the market are safe to use — whether they come from a manufacturer, seller, distributor or importer.
CDSCO is the regulatory body that issues every licence required to regulate medical devices in India.
Read NowWhat is a Medical Device Import License?
The CDSCO medical device import license is an authorisation certificate issued by the Central Drugs Standard Control Organisation as per the Medical Devices Rules, 2017. It is the primary requirement before starting the import of medical devices in India. All medical devices imported into India must follow the medical device regulations set by CDSCO — the import license grants legal approval and confirms that the products meet the required standards of quality and safety.
Role of medical device regulation
CDSCO makes every effort to ensure that only safe and effective medical devices enter the market. The list of approvals is very large — it covers everything from diagnostic equipment and surgical instruments to medical software.
Significance of the CDSCO Import License
Importer registration is necessary for everyone who wants to bring medical products into the Indian market. Its main benefits are:
- Ensure Quality & SafetyProducts reaching the market are safe and reliable, which reduces the risk of unsafe devices for patients and healthcare providers.
- Regulatory ComplianceThe certificate shows that the importer follows the framework set by CDSCO, and works as evidence during any regulatory check.
- Monitoring & TraceabilityThrough importer registration, CDSCO can track which devices enter the market, so buyers know the product is approved.
Types of Medical Devices in India
- Notified medical devices — devices regulated under the Medical Devices Rules, 2017. If they are made in India the manufacturer needs a manufacturing licence; if they are made outside India, an import licence is required.
- Non-notified medical devices — devices listed on the CDSCO portal. To sell and market these, a foreign manufacturer must have an authorised Indian agent.
Risk Classification of Medical Devices
Every device falls into one of four risk classes, and the class decides the documents and the fees.
- Class ALow Risk
- Class BModerate Risk
- Class CAverage Risk
- Class DHigh Risk
ELT Corporate experts simplify the process of obtaining your medical device importer license under CDSCO — from document preparation to final approval.
Who Can Apply?
- Wholesaler & DistributorA medical device wholesaler can apply for the importer licence under CDSCO.
- Medical Device ManufacturerA manufacturer can apply for sale and distribution, but must hold a manufacturing licence.
- Authorised Indian AgentUnder the CDSCO rules, an authorised Indian agent can apply for the import licence.
Process of MD-15 Import Registration
- Fill & submit the applicationForm MD-42 (wholesale licence) or Form 20B & 21B to the State Licensing Authority
- Apply for the import licenseAfter the wholesale licence is approved, apply on the SUGAM portal
- Application reviewedThe regulatory authority reviews the submitted application
- Inspection (if required)Inspection of the foreign manufacturing site by CDSCO or a notified body
- Approval & issuanceOn successful review, CDSCO issues the import licence in Form MD-15
Information Required in the Application
- Applicant & manufacturer details — company and manufacturer names, addresses, contacts, importer and local representative information
- Product details — device name, category, description, intended use, materials, specifications, storage conditions, labelling, accessories and packaging
- Regulatory status — approvals such as EU (CE) and US FDA, ISO/EN certifications and withdrawal records, if any
- Master file — shelf life, testing, manufacturing process, risk assessment, GMP certificate, biocompatibility and toxicology where applicable
- Devices with medicinal products — clinical trials, sales data, endorsements and batch release certificates
- Post-market surveillance — complaint handling, distribution records, recalls and adverse event reporting
Government Fee for the Import License
| Licence | Fees |
|---|---|
| Class A medical device (other than IVD) | One site $1,000 · each distinct device $50 |
| Class B medical device (other than IVD) | One site $2,000 · each distinct device $1,000 |
| Class A or B in vitro diagnostic device | One site $1,000 · each distinct device $10 |
| Class C or D medical device (other than IVD) | One site $3,000 · each distinct device $1,500 |
| Class C or D in vitro diagnostic device | One site $3,000 · each distinct device $500 |
Documents Required
- Notarised Free Sale Certificate from the country of origin or an approved country (USA, EU, etc.)
- Latest inspection or audit report (last 3 years)
- Notarised ISO 13485 certificate
- Notarised CE certificates — quality assurance, design and declaration of conformity
- Plant Master File (Appendix I) and Device Master File (Appendix II)
- Label with importer details, lot number, quantity and manufacturing date
- Notarised overseas manufacturing site registration
- Selling and distribution licence
- Proof of the government fee for importer registration
- For renewal: old licence and fee challan
Validity & Timeline
The CDSCO import licence is valid for 5 years from the date of issue for Class A, B, C and D devices. After expiry the importer has to renew it — for renewal all documents are not needed, only the old import licence and the fee challan.
The usual timeline for a medical device import license is 6 to 9 months. It varies with the complexity of each step. If any omission is found in the application or documents, the licence gets delayed — so make sure the application carries complete information.
As per the final notification by CDSCO, a Class A non-sterile and non-measuring medical device no longer needs registration under MD-15. It can proceed with a voluntary registration number, which the ELT Corporate team can help you obtain.
Why Choose Us
ELT Corporate is a trusted name in medical device regulatory consulting. We offer complete assistance to importers looking for a medical device import license in India. With ELT you get:
- Expert, personalised and timely approvals
- Licences handled strictly as per regulatory norms
- Devices reaching the end user safely, without legal and penal risks
- Smooth access for innovative medical devices from overseas
- Timely and on-demand services
- 1900+Clients Served
- 10+ YearsRegulatory Experience
- 5 YearsLicence Validity
- 6-9 MonthsUsual Timeline
Frequently Asked Questions
It is the import licence issued by CDSCO under the Medical Devices Rules, 2017, which allows a medical device to be imported into India.
No. Import of notified medical devices without a valid CDSCO import licence is not allowed.
A foreign manufacturer cannot hold the licence directly — an authorised Indian agent holding a valid wholesale or manufacturing licence applies on their behalf.
It is the file (Appendix II) that carries the device details — design, materials, testing, shelf life, risk assessment and manufacturing process.
Also called the Plant Master File (Appendix I), it describes the manufacturing site, its quality system, equipment and processes.
A certificate from the country of origin stating that the device is freely sold there. A notarised copy is required with the application.
Apply for renewal with the old import licence and the fee challan — the full document set is not needed again.
It depends on the device class and the number of sites and devices — see the fee table above.
Note: this page is for general information and is not legal advice. Requirements can differ case to case — talk to our team about your device.
From documentation to final approval, our regulatory team handles the entire process for you.