CDSCO Medical Device Import

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.

• 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.

• 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.
• 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.

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.

• 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.

• 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).
• 01. Corrective name and capacity listed in accepted advertence nomenclature, forth with the allotment of anniversary additive in the cosmetic, active by an authorised alone and formed by the maker.
• 02. Only the colours, pigments, and dyes accustomed by the BIS, which includes the 10th schedule, may be acclimated in cosmetics that are fabricated or imported.
• 03. The acceptable accustomed and constructed amoebic colours acclimated in the Corrective may not comprise added than:


• 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.



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.

• Step 1: When a ambassador intends to annals their articles in India, they charge aboriginal argue the CDSCO's Gazette Notification afore extensive a final cessation apropos the device's authoritative cachet and categorization.
• Step 2: Appointment of an Indian Representative To acquaint with the CDSCO, the architect charge accredit an authorised Indian agent. A Power of Attorney will be provided to the abettor to baby-sit allotment and importing in India and aid with corrective permits.
• Step 3: Complete the CDSCO Corrective Acceptation Allotment Appliance Form: The importer or maker of cosmetics charge abide the Allotment Anatomy to the Drug Controller General of India (DGCI) by logging assimilate the CDSCO website afterwards establishing an agent, calm with all the accordant acknowledging affidavit and the assigned fee.
• Step 4: Issuance Of CDSCO Corrective Acceptation Allotment Certificate: Afterwards the appliance form, documentation, and fee are submitted on the CDSCO website, the DGCI Allotment Ascendancy may acquaintance the architect or the authorised importer abettor with a catechism via an analysis letter. A corrective acceptation licence may be issued already the ascendancy is absolutely annoyed with the application.