As per the CDSCO guidelines if you are willing to import any medical device in Indian boundaries then you must have a CDSCO import license. CDSCO is a government regulatory body that helps you to obtain a license related to medical device industry startup. If you are in the medical industry then you must obtain the license.

If you are planning to obtain the license then you must understand the steps of license application. Here you will get to know about the steps that help you to apply for the CDSCO import license.

What Is a CDSCO Import License?

The CDSCO import license is approved by the Central Drugs Standard Control Organization for the import of medical devices from one place to another. This will help you to avoid all unnecessary hindrances from the side of the government. Through this license, you can simply import medical devices. This is necessary for the manufacturers also if they want to import medical devices in India. So to obtain a CDSCO import license you must dive deep for the licensing purpose.

Process To Apply for CDSCO Import License

To obtain a CDSCO import license, we need to follow the steps given below,

Step 1: The CDSCO Medical Device Import License application in India concerning the premises and devices produced by the Manufacturer & meant for import into India must be made by the Manufacturer or Importer or their agent in India, in Form 40. The application to obtain a CDSCO import license for medical devices in India addressed to the Drugs Controller General of India shall be deposited at CDSCO.

Step 2: Make the payment of the fee along with the application as the CDSCO Import License fee for the premises or units where the Manufacturer produces the devices aimed to be imported.

Step 3: Pay a fee for the Single Device Registration in India (which may contain a variation in shapes or sizes without any changes in the method of use or material) and pay an additional fee for each additional device.

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

Step 5: The information and undertakings needed under Schedule DI and DII may be changed to appropriate the requirements of devices in place of everyday pharmacological products. The information shall compose 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 authorized representative;
• Local Manufacturer, if any processing is being finished in the country.

Product’s Information:

• Brand or Proprietary name;
• Device category;
• Method of use and intended use;
• Brief description of the device;
• Brief detail of the manufacturing method & specification of the materials used;
• Variations in size, style, or shape of the device, if applicable;
• Recommended storage conditions;
• Warnings, contraindications, precautions for potential adverse events, and another therapy, wherever applicable;
• Summary indications of any reported issues;
• Quantitative & qualitative specifics of the constituents;
• Standards details to which the device conforms along with the copy of the standard;
• List accessories and other equipment or devices to be used with the device. Other description details containing accessories packaged with the product;
• Packaging description containing pack sizes;
• Labeling informations conforming to Drugs & Cosmetics Rules, 1945;
• Promotional Literature & Physician manual in English;
• The device is used in the medical specialty.

Regulatory Status:

• Product approval from any other regulatory agency (individual evidence for the approval from each category)
• EU medical device directive (CE Certificate);
• Approval in any other country;
• US FDA Approval or Clearance;
• Japan, Australia, or Canada approval.
• List of nations where the device is being sold.
• Copy of ISO Certification or EN, if any, for the manufacturing facility.
• List of countries where the medical device is withdrawn from sale with reasons if any.
• Master File (Details On Good Manufacturing Practices Employed By The Manufacturer to Ensure the Device Quality):
• Shelf life of the device;
• Device Master File;
• Functionality Test protocol & report, if applicable;
• Stability data or statement of established stability of material used as suitable;
• Flow chart or manufacturing process;
• Risk Assessment as per ISO 14971;
• Quality Assurance procedures or Process Controls;
• Sterilization process & Verification or Validation;
• Device GMP Certificate;
• Material or Component used;
• Final product testing or design inputs and outputs verification, if applicable;
• Biocompatibility & Toxicological data, wherever applicable.
• Devices Containing Medicinal Products:
• Clinical data & published articles, if any;
• For medical devices not authorized for marketing in the country, the applicant shall submit reports of sales details, clinical trials, a certificate of satisfactory use from the medical experts about the use of the device, and product complaints’ information, if any;
• If the device contains a medical product, which is liable to act upon the human body with action ancillary to that of the device, the safety of the data, quality, and usefulness of the used medicinal substance;
• Batch Release Certificate for items or products containing any medicinal substances of animal origin;
• If the device aims to deliver medicinal substances, data on compatibility with medicinal products or items is needed.
• Post-Market Surveillance:
• Handling of complaints;
• Procedures for distribution of records;
• Procedure for product recall;
• Adverse incident reporting.
• The undertaking of conformity concerning product standards, effectiveness, safety, and quality systems in the country of origin.

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

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

What is CDSCO Registration for Import License?

We need approval from the Central Drugs Standard Control Organisation to ensure the efficiency and quality of the medical devices the masses use. This process is CDSCO registration.

It is a crucial certificate to obtain from the manufacturers who deal with medical devices, mainly in the import activity in India. Plan to bring all Medical Devices, including implants and contraceptives, under a review of CDSCO announced by the Indian Government.

Regulatory Bodies Responsible for Medical Device Import License in India

The primary regulatory bodies that are accountable for CDSCO Import License in India are as follows:

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

Validity of Import License

License renewal should be paid each time before completion of the period of 5 years from the date of grant of the import license unless it is cancelled or suspended by the Central Licensing Authority (CLA).