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 Import Licenses for devices brought into India. Therefore, all medical devices imported into India must comply with the regulatory standards established by the CDSCO.

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.

What Are The Benefits of Getting a Medical Device Import License in India? 

The various benefits of a Medical Device Import License are:

• Ensure product safety and quality standards as per CDSCO
• Enhance market credibility and Brand Reputation
• Maintain legal compliance
• Avoid fines and any legal consequences
• Provide quality assurance of the product
• Develop new market opportunities
• expand globally

Who Can Apply For Medical Device Import License?

1. Any person who wants to start an import business of medical Device
2. Any Manufacturer or Importer
3. Any authorised person on the behalf of Manufacturer or importer or foreign manufacturer or importer

Documents Required For  Medical Device Import License

The list of various documents required for the seamless process of a Medical Device Import License is:

1. Cover Letter
2. Application Form MD 14 mentions all the details of the applicant and the medical device
3. Notarized copy of ISO 13485 Certificate of Actual Manufacturer (for quality management system)
4. Self-attested copy of valid manufacturing license.
5. Notarized copy of Free Sale Certificate
6. Risk Management Plan
7. Clinical Evaluation Report
8. Labels and IFU (Instructions for Use)
9. Usage Instruction and Warnings
10. Payment Receipt
11. GST Certificate
12. Power of Attorney Certificate
13. Notarized CE Design certificate
14. Undertaking of Authenticity of Information Provided
15. Notarized Quality Assurance Certificate
16. Notarized Declaration of Conformity
17. Schedule D(I) Documentation
18. Device Master File (DMF)
19. Plant Master Report (PMR)
20. Free Sale Certificate (FSC)

Procedure to Apply For Medical Device Import License

The various steps to be followed for the seamless process of import of Medical devices in India are given below. If you find difficulty in understanding the process, can take help from Expertise for easy and effective results. The steps are:

1. Check if the product requires registration as per Medical Device Rule, 2017(Regulated/Non-Regulated)
2. Check the classification of the product based on risk level if it requires registration
3. Visit the CDSCO Online SUGAM Portal and fill out the MD 14 application form for all the classes of medical device
4. Submit all the essential documents along with the application form
5. Make fees payment as per device classification(A,B,C,D)
6. Review and verification of application documents by CDSCO as per Regulatory requirements
7. Sometimes CDSCO ask for site inspection and additional documents if  they are not get satisfied with the already submitted documents
8. Issuance of Import license MD 15 if all criteria are fulfilled

Fees For Medical Device Import License

• Import license for Class A medical device other than in vitro diagnostic medical device

       (a) one site $1000

       (b) each distinct medical device. $50

• Import license for Class B medical device other than in vitro diagnostic medical device

        (a) one site  $2000

        (b) each distinct medical device  $1000

• Import license for Class A or Class B in vitro diagnostic medical device

         (a) one site  $1000

         (b) each distinct in vitro diagnostic medical device $10

• Import license for Class C or Class D medical devices other than in vitro diagnostic medical devices for

         (a) one site $3000

         (b) each distinct medical device  $1500

•  Import license for Class C or Class D in vitro diagnostic medical device

           (a) one site  $3000

          (b) each distinct in vitro diagnostic medical device $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 Import License, the Importer has to renew the 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.

How ELT Assist you For Medical device  Import  License

Our assistance helps clients in getting 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