CDSCO Authorized Agent Support
Medical Device
Enter the Indian life sciences market with confidence and compliance. CliniExperts is your trusted “Authorized Agent for Medical Devices” in India, ensuring all necessary import compliance for your products and enabling you to appoint an Indian distributor with ease. As your authorized agent, we take care of all necessary import compliance to ensure your products meet the requirements of the Drugs and Cosmetics Acts for Drugs and Biologics, as well as the MDR’17 for Medical Devices in India.
Manufacturer
Authorized Representative (CliniExperts)
Distributers
India Markets
Authorized Agent For
Medical Device – Overview
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.
Who Would Need An Authorized Agent Service?
Any foreign company who want to capture the Indian market but does not have its business operations or partner in India.
Services CliniExperts Provides As An Authorized Agent
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:
Import License in FORM MD-15
It is mandatory to have an Import license import and sell the products to multiple distributors and it can only be issued in name of your Authorized agent.
Post-market surveillance
As your appointed authorized agent support, CliniExperts is responsible for post-market surveillance, product performance, QMS and recall of the products.
Import Assistance
We take care of all necessary import compliance to ensure your products meet the requirements of the Drugs and Cosmetics Acts for Drugs and Biologics, as well as the MDR'17 for Medical Devices in India.
QMS
We can be your support partner in QMS services for medical devices in maintaining product quality, regulatory compliance, and patient safety throughout the entire lifecycle of medical devices – from conception and development to manufacturing, distribution, and post-market surveillance.
Custom Clearance
Import License holder will be responsible for customs clearance & delivery of products to Indian distributors. As appointed authorized agent CliniExperts will help you in placement of order, dispatch and custom clearance and delivery of products.
Warehouse and CFA Support
Cliniexpets can assist in optimizing supply chain efficiency, reducing operational costs, and enhancing customer satisfaction for successful carrying goods from the manufacturer to the distributor or retailer and provide essential services to ensure smooth logistics.
Why Choose CliniExperts as Authorized Agent
Single Representative
Single representative for the entire country, responsible for registering the products in compliance with Indian regulations
Single Window for Registrations
CliniExperts streamlines the registration process by providing a one- time activity that remains unaffected by distributor changes.
Flexibility in Distributor Appointments
As your products are registered under CliniExperts’ name, you can appoint multiple sub- distributors at any time, without facing business interruptions. This also means you’re not dependent on a single distributor and can easily switch if needed, without having to re- register.
Single Window for Regulatory Compliance
CliniExperts will ensure that all necessary regulatory compliances are met, so you can focus on your business operations without worrying about navigating complex regulatory requirements.
Pharmacovigilance / Post Marketing Surveillance
CliniExperts shall ensure to comply the guidelines to collect the safety and efficacy of data of the products placed in the market
Post Approval Life Cycle Management
As a leading regulatory service provider, CliniExperts has first insights to get updates on amendment in rules, which may apply to approved product to follow guidelines and CliniExperts is capable to follow these guidelines.
Essential Tips
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
India Regulatory Expert Series
Expert Advise
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.
Certifications and Accreditations
With these certifications, we demonstrate our dedication to quality, safety, and customer satisfaction.
ISO 9001
ISO 27001
Wholesale
Primary Service
Import license for predicate Medical Device (Form MD 14, 15)
Regulatory Body: CDSCO Application Forms: Form MD 14, 15Meet all your Regulatory Compliance needs. CliniExperts' professionals help you plan and streamline regulatory approval processes.
Who Can Apply
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.
Other Related Services
Wholesale License (Form 20B, 21B)
Importer | Regulatory Body: SLA
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.
New Medical Device permission (Form MD 26, 27)
Importer | Regulatory Body:CDSCO
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
Test License to import Medical Device (Form MD 16, 17)
Importer | Regulatory Body:CDSCO
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.
Frequently Asked Questions
Why would I require authorized agent support?
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.
How I will be benefitted to appoint you as my authorized agent instead of my existing distributor in India?
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.
Apart from being an authorized agent, what additional services will be offered by CliniExperts?
Additional services offered by CliniExperts include:
- Import assistance and customs clearance support
- Warehouse and CFA support to distribute your products
- Distributor’s identification to identify and map potential distributors to launch your products in India
- Post-market surveillance and Pre-certification support
Which sales model is being offered by CliniExperts?
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.
What are the legal compliances needed to opt these services?
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.