CDSCO Medical Device Import License Service In Chennai

Importing medical equipment into India is essential for any manufacturer. Manufacturers must meet all requirements for quality and efficacy in order to sell their products in India. The Drug & Cosmetics Act, 1940 and Rules, 1945 govern the distribution, sale, manufacture, and import of cosmetics, drugs, medical devices, and IVDs in India. If you want to import medical devices into India, you must first obtain a Medical Device Import License from CDSCO. Only when you have this licence may you import medical devices into India.

The DCGI is not involved in the regulatory oversight that the Central Government oversees over these goods that are imported into India through CDSCO. The State Drug Control Authorities, which are appointed by the State Governments, are largely responsible for regulating the sale, production, and distribution of medical devices. Obtaining a Medical Device Import License in India is primarily intended to assure the accessibility of safe, effective, and high-quality medical devices that are founded on scientific excellence and the best regulatory procedures.

Which regulatory bodies in India are largely in charge of issuing medical device import licences?

The following are the principal authorities responsible for India's CDSCO Medical Device Import License:

• India's Drug Controller General (DCGI)
• "Central Drug Standards Control Organization" (CDSCO)
• India's Drugs & Cosmetic Acts and Rules regulate or control the import, manufacturing, sale, and distribution of various medical equipment.

       

Type of Medical Devices in India

01. Non-Notified Medical Devices: Non-Notified Medical Devices: These medical devices must be listed on the CDSCO official portal even though they are not on the list of Notified Medical Devices. Foreign manufacturers must have an IAA headquartered in India in order to market these devices.

02. Notified Medical Devices: Notified Medical Devices: According to the CDSCO's Medical Devices Rules, 2017, this list of medical devices is subject to regulation. Devices that have been notified and are made in India must receive a manufacturing licence from the CDSCO, while those made outside must obtain a medical device import licence. The producers of newly notified devices in India are required to submit basic information, including manufacturing site information, manufacturer information, device information, FSC (Free Sales Certificate) or CFS (Certificate of Free Sales) information, and an applicant's commitment.

Who can Import Medical Devices into India?

 

Any individual, business, or other organisation, etc., that has been granted a manufacturing or wholesale licence under to the Drugs and Cosmetics Act, 1940 and Rules, 1945, may apply for registration and importation of medical devices into India.

What prerequisites must be met in order for a medical device import licence to be granted?

Rule 25A of the DCR states that the licencing authority must take the following into consideration before granting a medical device import licence

• whether the locations where the imported substances will be stored have the necessary storage space for maintaining the qualities of the medicine to which the import licence is applicable
• Information about the trade, profession, or company that the candidate typically engages in.

 

Requirements for Import of Medical Devices in India

According to the Drugs and Cosmetic Act & Rules, import licences in Form 10 and registration certificates in Form 21 are needed for the import of certain medical devices into India. Medical device manufacturing facilities and sites must be registered with Indian Drug Regulatory, or the Central Drugs Standards Control Organization, in order to import medical equipment (CDSCO).

Procedure for CDSCO Medical Device Import License

Step 1: The Importer or Manufacturer, or their agent in India, must submit an application for the CDSCO Medical Device Import License in relation to the facilities and devices manufactured by the Manufacturer and intended for import into India, using Form 40 and in accordance with the procedures outlined in Rule 24A of the Drugs & Cosmetics Rules. The Drugs Controller General of India's request for a medical device import licence must be submitted through CDSCO.

Step 2: A cost for the CDSCO Medical Device Import License for the buildings or units where the Manufacturer is manufacturing the devices intended for import must be paid together with the application.

Step 3: New fees for each additional device must be paid in addition to the charge for the Single Device Registration in India (which may include variations in shapes or sizes without modifications to the manner of use or material).

Step 4: In accordance with the aforementioned rules, the fee must be paid via a challan

Step 5: In place of typical pharmaceutical items, the information and undertakings necessary to be provided under Schedules DI and DII may be modified to suit the requirements of devices. The following details must be included in the information:

• Details Of The Applicant:

 

01. The Company name, address, and phone number

02. Foreign manufacturer's name and address (manufacturing facilities)

03. A duplicate of the plant master file

04. The importer's name and address

05. The local authorised representative's name and address

06. If any processing is being done domestically, local manufacturer.

• Product’s Information:

 

01. A trademark or a proprietary name

02. Type of device

03. The use process and the intended use

04. A succinct explanation of the device

05. A brief explanation of the manufacturing process and the materials used

06. Modifications to the device's design, dimension, or shape, if any

07. Recommendations for storage

08. Where appropriate, warnings, contraindications, precautions for anticipated negative outcomes, and alternative therapies

09. Brief descriptions of any issues that have been reported

10. Specifications of the constituents' qualities and quantities

11. Specifications of the standards that the device complies with and a copy of each standard

12. A list of the devices and/or accessories that must be utilized with the device. Further details on the product's description, including any accessories included with it

13. A description of the packaging, including pack sizes

14. Labeling information that complies with the 1945 Drugs and Cosmetics Rules

15. English-language promotional materials and medical manuals

16. The device's use in a particular medical field.

• Regulatory Status:

 

01. Product approval from any other regulatory agency (with separate documentation for each level of approval)

02. EU Directive on Medical Devices (CE Certification)

03. Acceptance in any other nation

• US FDA Approval or Clearance

 

01. Approval from Japan, Australia, or Canada

02. A list of the countries in which the product is sold

03. A copy of the production facility's EN or ISO certification, if applicable.

04. A list of the nations where the item has been taken off the market, along with any justifications.

• Master File (Information on Good Manufacturing Practices Employed By the Manufacturer to Make Sure the Device Quality):

 

01. The device's shelf life

02. The device master file

03. The protocol and report for the Functionality Test, if applicable

04. Data on stability or a statement of the materials established stability, as appropriate

05. Flowchart or manufacturing process

06. Risk assessment in accordance with ISO 14971

07. Process controls for quality assurance

08. The procedure of sterilisation and verification or validation

09. GMP Certificate for Device

10. The substance or element used

11. Final product testing and, if applicable, design inputs and outputs verification

12. Where applicable, biocompatibility and toxicological data.

• Devices Containing Medicinal Product:

 

01. Clinical data and, if available, published articles

02. For devices that are not authorized for sale in the nation, the applicant must include reports of clinical trials, sales information, a certificate of satisfactory usage from the device's medical experts, and details of any product complaints

03. The safety of the data, the quality, and the effectiveness of the medicinal substance utilized, if the device contains a medical product that has the potential to act on the body in a manner unrelated to that of the device

04. Batch Release Certificate for goods containing any pharmaceuticals with animal origin

05. Information on compatibility with pharmaceutical products or equipment, if the device was intended to deliver pharmaceuticals.

(Medical devices that have received prior approval from one of the recognised regulatory authorities will be subjected to a condensed examination; only a summary of all the studies and information indicated above is to be supplied.)

• Post-Market Monitoring:

 

01. Resolving grievances

02. Record distribution procedures

03. The product recalls process

04. Reporting negative incidents

05. The commitment to conformance with national quality systems, safety and effectiveness requirements, and product standards.

Step 6: The Registration Certificate must be issued using the aforementioned guidelines' Form-41

Step 7: The Medical Device Import License application must be submitted in Form 8 and include a charge in the amount and format specified by the Drugs & Cosmetics Rules.

FAQ

 

In India, who controls the import of medical devices?

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

Is it feasible to submit both their import licence application and registration certificate at the same time?

Yes, you may submit a joint application for an import licence and registration certificate.

Is registration and an import licence required in India for the import of unnotified medical devices?

No, registration is not necessary for the import of such devices into India. However, some devices are subject to regulation under the Drugs and Cosmetics Act and Rules; as a result, registration and an import licence are necessary for import into India.

What is the term or validity of an Indian medical device import licence?

Until the expiration of the registration certificate, this licence is valid for three years.

Whether medical devices having a valid Import License can be Importer from any notified ports of India?

yes

When should an import licence renewal application be submitted?

If the importer and Indian agent are the same, the import licence application should be filed with the request for re-registration at least three months prior to the license's expiration.