CDSCO Authorized Agent Support
In-Vitro Diagnostic Kits
Importing an in-vitro diagnostic kit and selling it across the country can be overwhelming if you don't have any local establishments in India. With a well-established presence in India, CliniExperts can help you comply with CDSCO requirements and start selling your device in this emerging market. CliniExperts hold a drug wholesale license in Form 20-B and 21-B and can be your in-country representative and IVD importing a hassle-free process.
Authorized Agent For
In-Vitro Diagnostic Kits – Overview
In recent years, the Indian healthcare market is emerging as a valuable market for medical device manufacturers and importers. In India, the manufacturing, import, sale and distribution of medical devices are regulated under the Drugs and Cosmetics Act and Rules by The Central Drugs Standard Control Organization (CDSCO).
Several overseas medical device companies are interested in entering the Indian healthcare market but do not have a local presence or registered office in the country. Such foreign entities need to appoint an Indian authorized agent to act as their in-country representative and handle registration and post-market surveillance responsibilities.
In simple words, the authorized agent acts as a liaison between the government and the overseas manufacturer. An "authorized agent" is a person or entity in India who has been authorized by a foreign corporation to act on their behalf. The authorized agent will be responsible for the foreign company's import and business activities in India and ensure compliance with the Drugs and Cosmetics Act, 1940.
The authorized agents must have a valid wholesale license 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?
A foreign company interested in entering the Indian healthcare market and importing their products in India but doesn't have any establishment, registered office, or business partner in India will require to appoint an authorized agent.
Services CliniExperts Provides As An Authorized Agent
India's pharmaceutical market is expanding at a breakneck pace, and several new regulations and amendments have been issued in the past few years. The importers of drugs need to register themselves in the country and fulfil stringent quality control requirements with meticulous documentation. The documentation of regulatory procedures is time-consuming and requires an expert's eye.
CliniExperts holds a valid Drug Wholesale License in Form 20B and 21B and can act as your authorized representative in India. We, at CliniExperts, provide you with all the necessary assistance throughout the process of import to launch your product in time.
Owing to years of regulatory experience, CliniExperts authorized agents help clients with the following services:
Registration and Re-registration
License renewal
PSUR
AER reporting
Distributor identification
Regulatory compliance of labels as per new guidelines
Complaint handling
Query responses
Product recall support
Procure import license
Notarization of documents from different Embassies in India
Our expert and skillful team with immense experience in regulatory writing supports clients in regulatory processes to launch products hassle-free.
Responsibilities of
Authorized Agent
Authorized agents must have a wholesale license
Authorized agents should submit an application for an IVD import license to the Central Licensing Authority in Form MD-14 via a specified online portal of the Ministry of Health and Family Welfare in the Central Government.
After every five years from the date of issue, the authorized agent must deposit the license retention fee with the Central Licensing Authority.
Pre-certification and post-market surveillance enquiries are legally the responsibility of the authorized agent.
Authorized agent is also responsible for any medical device recalls
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
Expert Advise
The authorized agent should have a 'Power of Attorney's to submit documents to CDSCO.
The company should have a Free Sales Certificate (FSC) issued by the national authority of exporting country.
Primary Service
Import License of Predicate In Vitro Diagnostics (Form MD 14, 15)
Regulatory Body: CDSCO Application Forms: Form MD 14-15Get Your Import License today for In-Vitro Diagnostic (IVD) Kits and Medical Devices with CliniExperts. Hassle-free assistance in providing Import License of Form MD 15.
Who Can Apply
- The license to manufacture for sale or distribution
- A wholesale license for sale or distribution
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.
Frequently Asked Questions
What are role and responsibilities of an authorized agent?
Below are the conditions to be complied by the authorized agent/License holder:
- Licence shall be produced when requested by the Medical Device Officer or any other senior officer under the control of Central Licensing Authority or the State Licensing Authority.
- The licencee shall inform the licensing authority forthwith and, in all circumstances, within a period of fifteen days of any administrative action taken on account of any adverse reaction, such as market withdrawal, regulatory restrictions, cancellation of authorisation or declaration of the medical device as not of standards quality by the regulatory authority of the country of origin or by any regulatory authority of any other country, where the medical device is marketed, sold or distributed.
- Authorised agent in cases referred in clause (ii), shall stop immediately the despatch and marketing of the medical device referred in that clause.
- The Central Licensing Authority, after due consideration of the information as referred in clause (ii), may issue directions to the licencee in respect of marketing, sale or distribution of the medical device including withdrawal of medical device from the Indian market within a period as may be specified by the Central Licensing Authority.
- The authorised agent shall obtain prior approval from the Central Licensing Authority before any major change, as specified in the Sixth Schedule, is carried out and the Central Licensing Authority shall indicate its approval or rejection within sixty days
Who is an authorized agent?
An "authorized agent” means a person including any firm or organization who has been appointed by an overseas manufacturer through a power of attorney to undertake import of medical device in India.
Who can act as Authorized Agent in India for Import of IVDs?
A person including any firm or organization having license to manufacture for sale or distribution or wholesale license for sale or distribution.
What is the purpose of these services?
Any foreign institution must register its product under a legal name in India before being introduced in India. An overseas company that does not have an office or a business partner in India and intends to trade its products in the Indian market, must designate an Indian agent who is a legal entity in India.
What are the benefits to hire CliniExperts in place of my own distributor in India?
CliniExperts is India's premier regulatory and business consulting firm and significantly benefits foreign companies when registering. Also, you need only one Indian Authorized Representative to conduct business across all states in India, and CliniExperts can act as a neutral party for your company operations in India. Suppose you have your own distributor, but in the future don't get any business or are seeking another distributor, then you need to go through the registration process again to appoint another distributor. With CliniExperts, the registration process will be a one-time activity as it doesn't impact the business on changing the Indian distributor. You can appoint and replace multiple distributors with CliniExperts if they are not fulfilling business requirements. In addition, trying to setup your own office can be very expensive. Setting up, maintaining it and if it doesn’t succeed, then shutting it down – all these are time consuming and expensive affairs. With CliniExperts these all get eliminated. CliniExperts becomes the authorized agent and distributor for your IVDs and you can focus on sales instead of bureaucracy.
What additional services do you offer along with these services?
In addition to authorized agent support, CliniExperts also offers the following services:
- Assistance with imports and customs clearance
- Warehouse and CFA support to distribute your products
- Identification and mapping of possible distributors to launch your products in India
- Post-market surveillance and Pre-certification support
What kind of sales model do you have?
We function as a one-stop neutral party, taking care of registration, import, and round-the-clock logistics support, allowing you to focus on your business and expand your reach in the Indian market.
What are the legal requirements for using these services?
The appointed Authorized Agent is legally responsible for pre-certification and post-market surveillance inquiries. If any Adverse Events Reporting are reported in the future, product recall requests are made, or compensation is required, actual manufacturers will handle all legal compliances to CliniExperts.