Medical Device Authorized Agent
A company that is looking to promote its medical Device in the Indian market requires a medical device authorized agent or an in-country authorized representative for medical device if they do not have an official location of the business in India.
Medical Device Authorized Representative
The term “authorized representative” for medical devices refers to Medical Device authorized representative as any legal or natural person who has a local company within the territory. The manufacturer officially identifies the representative. can act, and even address the bodies and authorities in this country for the benefit of the manufacturer.
The requirements and duties of requirements and responsibilities of a Medical Device authorized representative differ between different health Agencies. For example, an Indian designated agent of Medical Devices acts as an intermediary between your company and CDSCO to bring medical devices from foreign to India. The typical responsibilities of an authorized representative are as follows:
- Act as a primary point of contact for Import/customs and regulatory authorities.
- The authorized agent is responsible for pre-certification and post-approval queries.
- Communication with regulatory authorities of the Medical Device and foreign manufacturers.
What Is The Role Of CliniExperts As An Indian Authorized Representative For Medical Devices?
An Indian Authorized Representative acts as your liaison with your national Competent Authorities (Ministries of Health). Your appointed medical device authorized representative will –
- Assist with medical device registrations as required.
- Your product should be identified on the labeling across India.
- Create a copy of the Technical File or CE Declaration of Conformity open to be inspected by a Competent Authority, upon request.
- Assist in Incident and Field Safety Corrective Action (FSCA) reports, working in conjunction with your distributors and with you.
Who Can Act As A Medical Device Authorized Agent?
Distributors or importers of the devices could be Authorized Representatives (AR) for the company in their respective countries. However, this arrangement can cause difficulties when the requirement for multiple distributors or a change in an existing distributor is identified.
The importer or distributor, who has the license for the device might be reluctant to allow a different distributor to sell the device. Manufacturers often end up having to register the device once more since distributors do not give No Objection Certificates (NOC) to allow the transfer of the device’s license. In light of all the scenarios, it is recommended that manufacturers appoint non-profit entities that do not have a commercial interest, such as CliniExperts, as their Authorized Representatives.
For foreign companies to be able to navigate regional regulatory prerequisites for registration, certification, and post-approval queries, CliniExperts acts as an authorized representative for companies from abroad.
Advantages of Appointing CliniExperts As An Authorized Agent For Medical Device
- Cost-effective
- The flexibility to change distributors
- A strong relationship with the regulatory body
- A qualified team of experts who have hands-on experience in every category of Medical Devices
- Extensive support for regionally specific regulatory difficulties
- A structured approach to guarantee rapid market access
- Offer support to customs clearance as well as assistance with imports
- Warehouse distribution support and CFAs.
- CliniExperts can assist to identify distributors of potential products that are launched within India in the capacity of an official agent.
- Support with legal certification as well as post-marketing surveillance support.
Services CliniExperts Offers As Medical Device Authorised Representative
It is really tough for a foreign medical device manufacturer to initiate and manage its operations in India due to high-cost involvement, yearly compliance, accounting requirements, and taxation policy and closure clauses. CliniExperts is a leading regulatory service provider and business consultant that offers you with the continuous support to market your medical products in India. CliniExperts’ expert team offers:
- Support to assist with imports as well as custom clearance
- Warehouse and CFA support for distribution of product
- Support in identifying potential distributors to launch products in India
- Support for legal certifications and post-marketing surveillance questions.