A foreign company who doesn’t have its establishment in India, wants to enter India market, then they can appoint an authorized agent to register and market their products in India. An “Authorized Agent” means a person or entity in India authorized by the foreign company. The authorized agent will be responsible for the import and business activities of the foreign company in India including compliance to the provisions of the Drugs and Cosmetics Acts in all respects. Authorized Agent must possess a valid wholesale license meant for the sale and distribution of products or services in India and should be able to file an application to Central Licensing Authority for Medical Device registration in India.
Any foreign company who want to capture the Indian market but does not have its business operations or partner in India.
It is difficult for a foreign manufacturer to manage its operations in India due to involvement of heavy cost, yearly compliance, accounting requirements, and taxation policy and closure clauses. CliniExperts is a leading regulatory and business consultancy that provides you with the continuous support to market your products (medical devices) in India. The team of experts at CliniExperts offers:
Support for import assistance and custom clearance
Warehouse and CFA support for product distribution
Support in recognizing potential distributors for launching products in India
Support related to legal certifications and post-marketing surveillance queries
Must possess a valid wholesale license meant for the sale and distribution of products or services in India
Should file an application in Form MD-14 to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare for the grant of import license for medical devices in India
Needs to make an application to the central licensing authority for the renewal of the license along with the prescribed fee post completion of five years from the grant of license
Is fully responsible for all legal certifications and queries related to post-market surveillance
Can recall medical devices at any stage if needed
Two main requisites while preparing for the process of license application are:
Possession of wholesale license for sale and distribution of medical devices in India
Appointment as an authorized agent
With respect to import of medical devices, the foreign manufacture has to submit
Power of attorney, allowing authorized agent to market their products in India on their behalf
Free Sale Certificate of their finished product in the GHTF countries
The documentary evidence need to be submitted to the central licensing authority at the time of grant of license and subsequently as and when needed.
Meet all your Regulatory Compliance needs. CliniExperts' professionals help you plan and streamline regulatory approval processes.
An authorized Indian agent must be appointed for the same. This agent must have a license to manufacture (for sale or distribution) or wholesale License FORM 20B & FORM 21 B (sale or distribution) as per the CDSCO guidelines. The agent will make an application to get the grant of medical devices import license by applying through the Sugam online portal.
CliniExperts offer strategic planning services during product registration in addition to finding distributors and acting as an authorized agent in India. Our hand in glove approach ensures that at no point you find yourself battling with any process by yourself.
Get experts assistance to avail Permission to import or manufacture medical device which does not have its predicate device in India as per MDR 2017
Need a permission to import medical device in India to demonstrate its performance? CliniExperts’ professionals have expertise and assist you in securing a medical devices test license for importers in Form MD 17 by CDSCO.
For a foreign company to market its product in India, the prime requisite is registration of products by an Indian establishment. Foreign companies without Indian establishment or partners need to have an authorize agent to undertake import of products in India on their behalf.
In order to initiate operations in India, only one Indian establishment is needed, In case you have your distributor and you would like to change your distributor afterwards, registration process needs to be carried out again. With CliniExperts, registration needs to be done only one time. You may add or change as many distributors as needed.
Additional services offered by CliniExperts include:
CliniExperts is an emerging business consultancy that focuses on all your business needs right from initiating registration of license, assistance in import of products to seamless logistics support throughout the process.
All the legal compliances including pre-certifications, post-marketing surveillance queries, product recall request or any other request to be placed are taken care by the appointed authorized agent.
