If are you a part of the medical device industry then you must be aware of its regulatory compliance process as per the CDSCO guidelines. Among the multiple registration or license here you will get to know about Medical Device Import License.
It is a mandatory documentation process that allows you to import medical devices easily. It shows that medical device is safe to use and complies all the regulatory standards.
So, Let’s dive deep to understand the role of import registration of medical device.
ELT Corporate provides expert, end-to-end support in navigating these complex regulations. Our team assists with documentation, and licensing applications, and ensures full compliance with CDSCO guidelines.
What Is a Medical Device Import License?
Medical Device Import License is an authorisation Certificate issued by the Central Drug Standard Control Organisation (CDSCO) per the Medical Device Rule, 2017. It is the primary requirement before starting the Import of Medical Devices in India. All medical devices imported into India must adhere to the medical device regulations set by the CDSCO. Obtaining a CDSCO import license is essential, as it grants legal approval and ensures that the products meet the necessary standards for quality and safety.
Why Do You Need Medical Device Import Registration?
The number of medical device import licenses is increasing because India’s medical devices industry has witnessed remarkable growth over the past decade. India is the 4th largest medical device market in Asia, behind Japan, China, and South Korea, and is ranked among the top 20 markets worldwide.
The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare (MHFW) and Directorate General of Health Services (DCGI), serves as the regulatory authority overseeing the production, distribution, and sale of medical devices in India.
The CDSCO ensures that all medical devices meet stringent safety and quality standards, and is responsible for issuing CDSCO Import Licenses for devices brought into India. Therefore, all medical devices imported into India must comply with the regulatory standards established by the CDSCO.
What Are The Benefits of Medical Device Import License in India?Â
When you obtain the license of import for medical devices in India then you will experience various benefits for businesses as follows:
- Ensure Product Safety and Quality Standards – The Import certification for medical devices ensures consumers about the product safety and quality as per CDSCO standards.
- Enhance Market Credibility and Brand Reputation – This will help organizations and business individuals to boost their brand reputation and market credibility.
- Maintain Legal Compliance – It ensures every consumer and marketer that the medical devices complies all mandatory regulatory standards as per the CDSCO guidelines and rules.
- Avoid Fines and Any Legal Consequences – Through this, you can simply get rid of the fines, penalties and legal consequences.
- Develop New Market Opportunities – When you show that you work as per the legal regulations and rules then this will build new market opportunities to bring business changes. Through this, a business person or organization can expand globally.
Who Can Apply For Medical Device Import License?
The following entities are eligible to apply for the medical device import license in India:
- Importer or Distributors who wish to import medical devices into India.
- Manufacturers (Foreign or Indian) looking to sell their products in India.
- Authorized Indian Representatives (AIRs) of foreign manufacturers.
- Indian Businesses engaged in the medical device trade.
Documents Required For Medical Device Import License
To apply for a Medical Device Import License, the following documents are required:
Company & Manufacturer Details
✔ Cover Letter (specifying the purpose of application)
✔ Application Form MD-14 (with applicant & product details)
✔ GST Certificate (for Indian businesses)
✔ Power of Attorney (PoA) – Notarized & Apostilled
✔ Constitution Documents of the Indian Entity (if applicable)
Regulatory & Compliance Documents
✔ ISO 13485 Certificate (for quality management system compliance)
✔ GMP Certificate (Good Manufacturing Practice Certificate)
✔ Free Sale Certificate (FSC) from the country of origin
✔ Risk Management Plan
✔ Clinical Evaluation Report (CER)
✔ Declaration of Conformity (Notarized)
✔ CE Design Certificate (if applicable)
Product-Specific Documents
✔ Labels and IFU (Instructions for Use)
✔ Usage Instructions and Warnings
✔ Device Master File (DMF)
✔ Plant Master Report (PMR)
✔ Batch Release Certificate
✔ Schedule D(I) Documentation
📌 Note: Additional documents may be required based on device classification (A, B, C, D) and regulatory requirements.
Procedure to Apply For Medical Device Import License
The step by step process to apply for the CDSCO Medical Device Import License in India:
You need to check or consult with the experts to determine if the medical devices falls under the regulated or non-regulated categories. Later you have to identify the risk classification (Class A, B, C, or D) as per CDSCO guidelines.
Create an account on the CDSCO Sugam Portal or if you have it then simply login into it. Submit the MD 14 form with all the required documents.
Based on the classification of medical devices simply pay a government fee or you can consult with the experts if you have any doubts.
CDSCO Officer or department will review the submitted application and documents. If required, the CDSCO department will request those particular documents or conduct an inspection.
Upon successful verification, the CDSCO Department will issue the MD-15 Medical Device Import License. The applicant can legally import medical Devices into India.
Important: If the application is incomplete, CDSCO may reject it or request corrections.
Fees For Medical Device Import License
The CDSCO fees for obtaining an Import License (MD-15) depend on the risk classification of the medical device:
| Medical Device Class | Site Registration Fee | Fee per Medical Device |
|---|---|---|
| Class A (Low Risk) | $1000 | $50 |
| Class B (Moderate Risk) | $2000 | $1000 |
| Class A/B (IVD Devices) | $1000 | $10 |
| Class C (High Risk) | $3000 | $1500 |
| Class D (Highest Risk) | $3000 | $1500 |
| Class C/D (IVD Devices) | $3000 | $500 |
Validity For Medical Device Import License
Medical device Import licence is valid for 5 years (Class A, B, C & D) from the date of issue. After the expiration of the CDSCO Import License, the Importer has to renew the CDSCO Import license. For renewal there is no need for all documents, only an old import licence and fee challan are required.
Timeline For Medical Device Import License
The timeline for a medical device Import License is 6 to 9 months. It varies as per the complexity of each step.
Is an Import License Required for All Medical Devices in India?
Yes, Except for certain Class A medical devices non-sterile/non-measuring, which only required voluntary registration. All other medical devices of other categories require an MD 15 Import License.
Which Regulatory Body Oversees Medical Device Imports in India?
The CDSCO (Central Drugs Standard Control Organization), under the Ministry of Health and Family Welfare (MoHFW) and Directorate General of Health Services (DGHS), regulates the import, manufacture, and sale of medical devices in India.
How ELT Assist You With a Medical Device Import License?
Our assistance helps clients in getting CDSCO Import License Certificates easily for starting the Import business of medical devices in India. Our expertise guides you in completing the Import registration process Review and arrange all the documents as needed for easy approval and provide a Quick service facility.
FAQs
Can I Modify The License To Include Additional Devices?Â
Yes, a license holder can apply for modifications if they wish to import new medical devices. The modification request is processed by CDSCO.
What If I Don’t Renew My License On Time?Â
If your license expires, you will no longer be permitted to import medical devices legally, and you have to pay penalties. It is crucial to renew the license before it lapses.
Can Foreign Companies Apply For a Medical Device Import License in India?
No, Foreign companies cannot apply for the medical device import license. They must appoint an Indian Authorized Representative (IAR) to apply for an Import License (MD-15) on their behalf.
Are Refurbished or Second-Hand Medical Devices Allowed for Import Into India?
No, as per the CDSCO regulations, only new medical devices with valid regulatory approvals can be imported.
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