CDSCO Import License for Medical Devices In India
Medical Device Import License:
Applicable when we have to import medical devices from other countries to India. However they need to be classified according to CDSCO notified devices list. CDSCO has complete procedure for granting license for medical device imported in the countries.
Application for grant of import license for medical device
- An authorized agent (who must have wholesale license for local distribution) having license to manufacture for sale or distribution or wholesale license for sale or distribution under these rules, shall make an application for grant of import license for medical device to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining a license.
- Where the Central Licensing Authority, has reason to believe that the quality of the medical device is compromised, and decides to subject to its evaluation, tests or evaluation, test or examination, to the testing laboratory as specified by the Central Licensing Authority.
- After examining the documents along with the application on the basis of the inspection report, if the inspection has been done by the Central Licensing Authority can be satisfied, grant license in Form MD-15 may reject this application for this reasons shall be recorded in writing within the time of nine months from the date of the application.
- In the process of rejection the applicant can make an appeal to the Central Government within the time of forty five days and that the Government, may after the enquiry in this matter pass order in relation there within the time of ninety days from the date of appeal.
Operon Strategist assists pharma or medical device distributors and medical device wholesalers in India to procure CDSCO import license. An Import license is issued for import of medical device from other country to India. Both the foreign company and Indian company jointly needs to submit the documentation for medical device and manufacturing unit.
Medical Device Registration for Import: -医疗设备必须在进入印度compliance with the Indian Medical Device Regulation set forth by the CDSCO. The CDSCO is responsible for the approval and regulation of New Drugs and Clinical Trials in the Country, laying down the standards for Drugs, control over the quality of imported drugs, coordination of the activity of State Drug Control Organizations.
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Phases in CDSCO Import License registration:
- Phase I – Applicant Registration
- Phase II – Import License application
Pre-requisites:
- Generic Name / Brand Name
- Intended Use
- Material of construction
- Mode of application
- Study of device details and Classification of medical device on the basis of notified product list of CDSCO
- Class of device helps in determining application form to be applied and also application fees.
CDSCO Import license registration phases
CDSCO Import license of medical devices is regulated in India that any industry or an individual having license (wholesale and/or manufacturing license issued under central drug standard control organization (CDSCO), Drugs and cosmetics act, 1940 and can import medical devices into India.
Under the new dispensation, foreign manufacturers have to apply for registration certificate for their manufacturing premises and the individual drugs to be imported. The applications can be made by authorized agents of foreign firms in India. The documents required for registration certificates have been clearly specified in the amendments. The validity of registration certificates will be 3 years from the date on which these are issued.
Phase I – Applicant Registration:
In this phase after applying client can have an active account on CDSCO Online System for Medical Devices registration site.
Procedure
第一次在网上m has to be filled and all above required documents have to be uploaded. In online form details of manufacturing company like complete corporate address, contact details like email and contact No., fax No., name of authorized person name, ID proof number, Company type (Ltd, Pvt. Ltd etc.), email id for registration, password, alternate email id etc.
Once form submitted, preliminary approval is received from CDSCO and subsequently hard copies submitted will be verified with online submitted information and documents.
Then CDSCO processes the application registration. Based on approval or rejection of application from CDSCO. Mail will be received stating reason for rejection or reapplication and same process have to follow again.
Phase II – Import License Application:
This license is required to have permission to import medical device for commercial purpose.
Procedure
For Application on online portal, form has to be filled with device related information like generic name, brand name, class of device, category of device, packaging configuration, shelf life, sterile / non-sterile, intended use, product description, accessories and model details if any.
After form filling, uploading of all above documents to be done. Then payment as per fee structure of CDSCO has to be done online. Upload payment receipt on online poral then a legal form will be generated based on product information filled and transaction done.
Application submitted will be moved to stage of In-process when review is in-process. Then either application can be approved or if any query raised then that query related revised documents or any justification for that have to be uploaded online against that query. If query compliance is acceptable then approval of test license will be received and email related to same will be send by CDSCO.
Operon strategist’s expertise
Operon strategist is the leading medical device regulatory consulting company; we provide regulatory guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals and certifications.
Competencies
- We reduce our client’s costs and efforts.
- We have Strong relations with regulated bodies.
- We also have dedicated and experienced regulatory team.
- We represent on behalf of our client’s for Audits of FDA, ISO, & CE.
- Competent Technical staff.
FAQs
Q1] Does cosmetics import require license from Indian FDA?
For the import of cosmetics in India, the imported cosmetics products are required to be registered with Central Drugs Standard Control Organization (CDSCO).Cosmetic products and color additions do not need FDA approval before they go in the market. Although they should not be contaminated or misbranded. It means that they should be safe for the customers under labeled customary conditions to use, and they must be properly labeled. In the case of color additions and those ingredients which are banned or restricted by FDA regulations, a cosmetic firm can use any ingredient as long as it does not cause the product to be contaminated.
Q2] How is IEC different from medical device import license?
IEC Import Export Code is the first requirement you before you start an import/export code in India. An IEC is important for the import and export of goods. The IEC is issued by the Directorate General of Foreign Trade (DGFT) Ministries of Commerce and Government of India. For releasing any medical device the manufacturer has to attach to various rules set by the national regulatory bodies of India. The main regulatory body of India is Central Drugs Standard Control Organization (CDSCO). It is under Directorate General of Health Services, Ministry of health and family welfare. Under the drugs and cosmetics act CDSCO is responsible for the approval of drugs, conduct of clinical trials, laying down the standard of drugs, control over the quality of imported drugs, in the country. Further CDSCO along with state regulators is jointly responsible for granting licenses of certain specialized categories of critical drugs such as blood and blood products I.V. Fluids, Vaccine and sera.
Q 3] Does medical device import require license from Indian FDA?
Ans-Yes. Under the provision of Drugs and Cosmetic act 1940, registration certificate and import license are required to import in India. For the introduction of medical device in the Indian market, the Manufacturers has to obey various norms set by national regulatory bodies of India. The main regulatory body for medical device in India is Central Drugs Standard Control Organization (CDSCO). The Application for all classes of medical devices are submitted to Central Licensing Authority, where the (DCGI) Drug Controller General of India takes the responsibility for approval of Manufacturing, Registration, Import and Sale of Medical Devices in India. When the Medical Device released to be imported it has some issued steps to be followed. The importers may also get the respective sale license from the State Licensing Authorities (SLA).