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:
- The Drug Controller General of India (DCGI);
- The CDSCO (Central Drug Standards Control Organisation);
- 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:
Low Moderate Risk
Type of Medical Devices in India
- 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.
- 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 Apply?
An Authorised Indian Agent must be appointed for the same. This agent must have a license to manufacture (for sale or distribution) or Wholesale License (sale or distribution) as per the CDSCO guidelines. The agent will make an application to get the grant of Medical Device Import.
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:
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-15.
Procedure for CDSCO Medical Device Import License
Step 1: Application for the CDSCO Medical Device Import License in India concerning the premises & devices manufactured by the Manufacturer and meant for import into India are required to be made by the Importer or Manufacturer or their agent in India, in Form MD-14.
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:
- Company name, address, and contact number of the applicant;
- Address & name of Foreign Manufacturer (Manufacturing Premises);
- Copy of the Plant Master File;
- Name & address of the Importer;
- Name & address of the local authorised representative;
- Local Manufacturer, if any processing is being completed in the country.
- Product’s Information:
- Brand or Proprietary name;
- Device category;
- Method of use and intended use;
- Brief description of the device;
- Brief description of the manufacturing method & specification of the materials used;
- Variations in style, size, or shape of the device, if applicable;
- Recommended storage conditions;
- Warnings, contraindications, precautions for potential adverse events and alternative therapy, wherever applicable;
- Summary indications of any reported problems;
- Quantitative & qualitative particulars of the constituents;
- Details of standards to which the device conforms along with the copy of the standard;
- List of accessories & other devices or equipment to be used in combination with the device. Other description information, comprising accessories packaged with the product;
- Packaging description comprising pack sizes;
- Labelling details conforming to Drugs & Cosmetics Rules, 1945;
- Promotional Literature & Physician manual in English;
- Medical speciality in which the device is used.
- Regulatory Status:
- Product approval from any other regulatory agency (separate evidence for the approval from each category):
- EU medical device directive (CE Certificate);
- Approval in any other country;
- US FDA Approval or Clearance;
- Japan or Australia, or Canada approval.
- List of nations where the device is being sold.
- Copy of EN or ISO Certification, if any, for the manufacturing facility.
- 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):
- Shelf life of the device;
- Device Master File;
- Functionality Test protocol & report, if applicable;
- Stability data /statement of established stability of material used as applicable;
- Flow chart or manufacturing process;
- Risk Assessment as per ISO 14971;
- Quality Assurance procedures or Process Controls;
- Sterilisation process & Verification or Validation;
- Device GMP Certificate;
- Material or Component used;
- Final product testing/design inputs & outputs verification, if applicable;
- Biocompatibility & Toxicological data, wherever applicable.
- Devices Containing Medicinal Product:
- Clinical data & published articles, if any;
- 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;
- 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;
- Batch Release Certificate for products or items incorporating any medicinal substances of animal origin;
- 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:
- Handling of complaints;
- Procedures for distribution of records;
- Procedure for product recall;
- Adverse incident reporting.
Step 6: After the completion of all the above steps the Medical Import License shall be issued in Form MD-15 by the concerned Department;
Validity of Medical Device Import License
The permission to import medical device is issued as Form MD-15 remains in perpetuity i.e., permanently as long as the payment of license retention fee is done from time to time. The License retention should be paid each time before completion of the period of 5 years from the date of issue of the import license unless it is suspended or cancelled by the Central Licensing Authority (CLA).
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, it is required.
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.