9289379709 7838392800

CDSCO Medical Device Import License

Medical Device Import License in India is managed by the CDSCO, under the Directorate General of Health Services in the Ministry of Health & Family Welfare. To get a Medical Device Import License without any hassle, contact Corpbiz.

  • We will help you in the application process
  • Help you in complete documentation
  • Delivering Medical Device Import License
  • End to end support
Watch Video   Schedule Free Consultation

Get Started

50,000+

Happy Customers

300+

Professionals

250+

Partners

Among Asia Top 100 Consulting Firm

50,000 + Clients

50,000 + Clients

Lowest Fees

Lowest Fees

300+ CA/CS

300+ CA/CS

4.9 Customer Rating

4.9 Customer Rating

An Overview of CDSCO Medical Device Import License in India

Medical device importation in India is vital for every Manufacturer. To import into India, manufacturers have to fulfil all the standards of quality & efficacy to enter the Indian market. In India, the Distribution, Sale, Manufacture, and Import of Cosmetics, Drugs, Medical Devices, and IVDs are regulated under the provisions of the Drug & Cosmetics Act, 1940 and Rules, 1945. In the case of importation of Medical Devices into India, then it is necessary to obtain Medical Device Import License under CDSCO; then, only you can import the medical devices into India.

The Central Government supervises regulatory control over these articles imported into India through CDSCO, which is overlooked by the DCGI. The sale, manufacture, and distribution of Medical Devices are primarily regulated by the State Drug Control Authorities appointed by the State Governments. The primary objective of obtaining a Medical Device Import License in India is to ensure the availability of secure, potent & quality medical devices based on scientific excellence & best possible regulatory practices.

Which Regulatory Bodies are primarily responsible for Medical Device Import License in India?

Following are the primary regulatory bodies that are accountable for CDSCO Medical Device Import License in India:

  1. The Drug Controller General of India (DCGI);
  2. The CDSCO (Central Drug Standards Control Organisation);
  3. In India, the import, manufacturing, sale & distribution of different medical devices are regulated or controlled under India’s Drugs & Cosmetic Acts and Rules.

Risk Classification of Indian Medical Device

You can check different categories of Indian Medical Devices from the table given below:

Device Class

Risk

A

Low Risk

B

Low Moderate Risk

C

Moderate-High Risk

D

High Risk

Type of Medical Devices in India

  1. Non-Notified Medical Devices: Non-Notified Medical Devices are not included in the list of Notified Medical Devices, but these types of medical devices shall be listed on the official portal of CDSCO. To market these devices, foreign Manufacturers shall have an IAA based in India.
  2. Notified Medical Devices: These devices are the list of medical devices regulated under Medical Devices Rules, 2017 by the CDSCO. The notified devices manufactured in India shall obtain Manufacturing License from the CDSCO and the devices manufactured in foreign countries shall obtain Medical Device Import License. The listing of newly notified devices in India requires the manufacturers to submit basic details like manufacturing site details, Manufacturer, device details, FSC (Free Sales Certificate) or CFS (Certificate of Free Sales) and undertaking by the applicant.

Who can Import Medical Devices into India?

Any person or enterprise or firm, etc., having a Wholesale License and/or Manufacturing License issued under Drugs & Cosmetics Act, 1940 & Rules, 1945 can be the applicant for Registration and Import of medical devices into India.

What are the conditions to be satisfied for the grant of a Medical Device Import License?

According to Rule 25A of the DCR, before issuing the Medical Device Import License, the Licensing Authority shall have regard to:

  • Whether the premises or units or sites where the imported substances will be stocked are furnished with proper storage accommodation for preserving or keeping the properties of the drug to which the import license applies;
  • Details of the trade, occupation, or business ordinarily carried out by the applicant.

Note:  Licensing Authority, on being satisfied that the conditions of the Medical Device Import License have been complied with, issues an Import License in Form-10.

Requirements for Import of Medical Devices in India

For the import of various medical devices in India, Import License in Form-10 and Registration Certificate in Form 21 are required as per the Drugs and Cosmetic Act & Rules. For the import of medical devices, the manufacturing products and site (medical devices) are required to be registered with Indian Drug Regulatory, i.e., the Central Drugs Standards Control Organisation (CDSCO).

Procedure for CDSCO Medical Device Import License

Step 1: Application for the CDSCO Medical Device Import License in India concerning the premises and devices manufactured by the Manufacturer & meant for import into India are required to be made by the Importer or Manufacturer or their agent in India, in Form-40 and a manner as prescribed under Rule 24A of the Drugs & Cosmetics Rules. The application for the Medical Device Import License in India addressed to the Drugs Controller General of India shall be deposited at CDSCO.

Step 2: A fee shall be paid along with the application as the CDSCO Medical Device Import License fee for the premises or units where the devices aimed to be imported are being manufactured by the Manufacturer.

Step 3: Also, a fee shall be paid for the Single Device Registration in India (which may comprise a variation in shapes or sizes without any changes in the method of use or material) and an extra fee for each additional device shall be paid.

Step 4: The fee shall be paid via a challan as prescribed under the said rules;

Step 5: The information and undertakings required to be provided under Schedule DI and DII may be changed to suit the requirements of devices in place of normal pharmacological products. The information shall include the following details:

  • Details of the Applicant:
  1. Company name, address, and contact number of the applicant;
  2. Address & name of Foreign Manufacturer (Manufacturing Premises);
  3. Copy of the Plant Master File;
  4. Name & address of the Importer;
  5. Name & address of the local authorised representative;
  6. Local Manufacturer, if any processing is being completed in the country.
  • Product’s Information:
  1. Brand or Proprietary name;
  2. Device category;
  3. Method of use and intended use;
  4. Brief description of the device;
  5. Brief description of the manufacturing method & specification of the materials used;
  6. Variations in style, size, or shape of the device, if applicable;
  7. Recommended storage conditions;
  8. Warnings, contraindications, precautions for potential adverse events and alternative therapy, wherever applicable;
  9. Summary indications of any reported problems;
  10. Quantitative & qualitative particulars of the constituents;
  11. Details of standards to which the device conforms along with the copy of the standard;
  12. List of accessories & other devices or equipment to be used in combination with the device. Other description information, comprising accessories packaged with the product;
  13. Packaging description comprising pack sizes;
  14. Labelling details conforming to Drugs & Cosmetics Rules, 1945;
  15. Promotional Literature & Physician manual in English;
  16. Medical speciality in which the device is used.
  • Regulatory Status:
  1. Product approval from any other regulatory agency (separate evidence for the approval from each category):
  2. EU medical device directive (CE Certificate);
  3. Approval in any other country;
  • US FDA Approval or Clearance;
  1. Japan or Australia, or Canada approval.
  2. List of nations where the device is being sold.
  3. Copy of EN or ISO Certification, if any, for the manufacturing facility.
  4. List of countries where the device is withdrawn from sale with reasons, if any.
  • Master File (Information on Good Manufacturing Practices employed by the Manufacturer to make sure the device quality):
  1. Shelf life of the device;
  2. Device Master File;
  3. Functionality Test protocol & report, if applicable;
  4. Stability data /statement of established stability of material used as applicable;
  5. Flow chart or manufacturing process;
  6. Risk Assessment as per ISO 14971;
  7. Quality Assurance procedures or Process Controls;
  8. Sterilisation process & Verification or Validation;
  9. Device GMP Certificate;
  10. Material or Component used;
  11. Final product testing/design inputs & outputs verification, if applicable;
  12. Biocompatibility & Toxicological data, wherever applicable.
  • Devices Containing Medicinal Product:
  1. Clinical data & published articles, if any;
  2. For devices not authorised for marketing in the country, the applicant shall submit reports of clinical trials, sales details, a certificate of satisfactory use from the medical specialists about the use of the device and product complaints' details, if any;
  3. If the device incorporates a medical product, which is liable to act upon the body with action ancillary to that of the device, safety of the data, quality & usefulness of the medicinal substance used;
  4. Batch Release Certificate for products or items incorporating any medicinal substances of animal origin;
  5. Data on compatibility with medicinal items or products if the device aimed to deliver medicinal products.

(Medical devices with prior consent from any of the recognised regulatory authorities will be subjected to an abridged examination and only a summary of all the studies & details described above is to be submitted).

  • Post-Market Surveillance:
  1. Handling of complaints;
  2. Procedures for distribution of records;
  3. Procedure for product recall;
  4. Adverse incident reporting.
  • The undertaking of conformity concerning product standards, safety & effectiveness necessities and quality systems in the country of origin.

Step 6: The Registration Certificate shall be issued in Form-41 of the said rules;

Step 7: The application for Medical Device Import License shall be made in Form 8 along with a fee in the form and manner prescribed under the Drugs & Cosmetics Rules.

How Corpbiz Will Help You?

Medical Device Import License in India under CDSCO requires lots of requirements & documentation. New applicants may find it difficult to fulfil such requirements & documentation. Hence, in such a case, it is strongly recommended to contact Coprbiz, who will guide you on each step of the licensing procedure. At Corpbiz, we simplify the process for our respected clients by addressing all the legalities on their behalf.

Frequently Asked Questions

CDSCO, DGHS, Ministry of Health & Family Welfare, and Medical & Diagnostics Division.

No, registration is not required for the import of such devices in India but, some devices are regulated under the Drugs & Cosmetic Act and Rules; hence registration & import license is required for import into India.

No, however, if needed, the applicant shall be accountable for paying the fee for expenditure as may be required for inspection or visit the site.

Yes, you can apply for both Registration Certificate and Import License together.

This License is valid for 3 years till the Registration Certificate is valid.

If the application is complete in all aspects and information is in a proper manner, then the licensing authority may within 3 months from the receipt date of an application.

Yes, the Importer shall inform the Licensing Authority immediately in writing and shall submit a new application as per the Rules.

Application for Import License should be submitted along with the application for Re-Registration provided Importer & Indian agent remain same or minimum of three months before the expiry of the Import License.

Why Corpbiz

50,000+ Clients Worldwide

50,000+ Clients Worldwide

 

4.9 Customer Rating

4.9 Customer Rating

 

300+ Team CA/CS/Lawyers

300+ Team CA/CS/Lawyers

 

Fill Up Application Form

Make Online Payment

Executive will Process Application

Get Confirmation on Mail

Our Network Partners

Transform your Business. Subscribe our Newsletter.