Medical Device- For Importers

Medical Device- For Importers

 

The Government of India, formulated the New Medical Rules 2017, describing some changes and new additions. The new rules have now classified medical devices which were earlier not classified and have also changed rules related to the import of medical devices.

The documents necessary for applications follow global formats which makes the process standardized and also easy for foreign companies seeking a share of the Indian market.

Obtaining permission for importing medical devices in India is now a quick single-step process. The process for granting the permission for import has been simplified. Pertaining to the new rules, now the medical devices can be imported by more than one importer in the country. Where each importer needs to obtain a separate import license for the same.

At CliniExperts, we possess the required resources and team of experts to help obtain an import license for foreign or Indian manufacturers. We are well versed with the new Medical Device Rules formulated by CDSCO and provide end-to-end service and support to the importers.

 

Authorized Agent/Registration Holder

The new medical device rules 2017 forbid a foreign company to apply for an import license directly to CDSCO. A foreign company must appoint an authorized agent holding a valid license to apply and act on behalf of the company.

An authorized agent here refers to a person, firm or organization which has been appointed by the foreign company using the power of attorney to undertake the import of medical devices in India.

CliniExperts, holds a valid wholesale license (Form 20B and 21B) which allows us to act as an Authorized agent on behalf of a foreign company seeking permission to import medical devices in India. This helps the foreign company to save time and resources in setting up an office in India. For more information contact.

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Permission for Import License (Form MD-14, Form MD-15)

The application for obtaining the import license must be filed using form MD-14. The application form has to be filed by an authorized agent, in case the applicant is a foreign company. The authorized agent applying on behalf of a foreign company must hold a valid wholesale license for the sale and distribution of drugs. The import license is further granted in form MD-15, by the Central Licensing Authority.

CliniExperts holds a valid wholesale license for the sale and distribution of drugs and also a valid license to act as an authorized agent on behalf of a foreign company vying to import medical devices in India. Out technical team also helps our clients in obtaining the import license quickly and without hassle. For more information contact.

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Permission For Test License To Import Medical Device (Form MD-16, Form MD-17)

Companies often require to import medical devices in small quantities for the purpose of clinical investigations, demonstrations, test, evaluation of training of medical staff. The law requires them to apply for a test license to import such medical devices.

The company desiring to import a medical device for test must apply for a test license for importing medical device to the Central Licensing Authority using form MD-16. The license whereby is granted in form MD-17.

The dedicated team of professionals at CliniExperts, will help you in filing an application for obtaining a test license.
For more information contact.

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For assistance on any of the above services, please feel free to reach us at +91-767 20 05 050 or email us at contact@cliniexperts.com
 

 

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