DIAGNOSTIC KIT REGULATORY SERVICES
Indian Agent Representation/Authorized Agent Support – IVD Regulatory Services
NKG team has a cumulative experience of more than 70 Years in Regulatory affairs and have been Behind Breakthrough Medical Devices Technology approvals helping Various Clients to Device Regulatory Pathwork for Successful Launch.
In a phased manner, the New Medical Device rules and regulations are being notified by the authorities for IVD Kits in India from time to time while the filing of applications is based upon the risk classification of such diagnostic kits.
Our team has designed regular and value added services for Indian Manufacturers, importers , overseas IVD Kits manufacturers looking to place their products in the Indian Markets. These services have been designed in a way to cover the exhaustive spectrum of regulatory needs that may be required from time to time.
Services for IMPORT OF APPROVED IVD KITS
New Medical Devices Rules 2017 and regulations cover Import of In vitro diagnostic kits or IVD Kits through. SUGAM ,a online platform, Made by Central Drugs Standard Control Organisation wherein applications for the same can be submitted and permissions granted.
Importers who wish to import IVD Kits classified under any risk class i.e. Class A , Class B Class C or Class D need to submit respective Online applications on SUGAM Portal of CDSCO which is the Central Licensing Authority for such products.
Indian Agent Representation / Authorised Agent Support/ Registration Holding Services
In India, An Overseas Manufacturer cannot submit an application for registration as applicants. Having an Indian Entity as authorised agent or license holder is mandatory in order to submit an application for registration of imported IVD Kits. A registration certificate once issued to an overseas manufacturer and an Indian Entity can be used by only such companies to import products in India.
These services are designed for clients who wish to
- Work with multiple business partners in India
- Protect their confidential information such as manufacturing site information, product formulations, specifications etc from their business partners
- Have control of the registration certificate in their own hands
As per Medical Devices Rules 2017, One of the ways an overseas manufacturer of Medical Devices can enter into India is by appointing an Authorised Agent.
An “Authorized Agent” means a person including any firm or organisation who has been appointed by an overseas manufacturer through a Power of Attorney to undertake import of Medical Device or IVD Kits in India.
An authorized agent must hold a valid wholesale license to undertake the import procedure. NKG ABC holds a valid import license (Form 20B and 21B) to assist foreign manufacturers to import their IVD Kits in India in less time and without any hassle.
NKG understands the needs of global brand owners. NKG offers bespoke services to such Brand Owners. NKG can be nominated by overseas brands to act as its Authorised Agent in India.
NKG Benefits:
- NKG has all the requisite government licenses to Act as an Authoirised agent.
- NKG is strategically located in New Delhi, the regulatory capital of India.
- NKG will become a single point of contact for all government communications.
- NKG will allow brands to use the name and address of NKG on the product labels.
- NKG can handle Pre certification & Post Market Surveillance activities
- NKG protects confidential information of the brand
- NKG delegates the control of the registration certificate to the Brand owner.
Through our Indian Agent Representation / Authorised Agent Support/ Registration Holding Services, NKG provides a home away from home. On one hand, although NKG will add a layer in the business transaction by coming in between the Brand owners and the Indian Business partners, on the other hand, NKG has no commercial conflict of interest and will act purely from a Service view working on the directions and instructions of overseas brands.
As Guardians of the Registration Certificate with the Indian Government, we ensure complete regulatory compliance and confidentiality.
Plus for the Brand
By-Pass the possibility for Re-Registration in case there is a change in your Indian Distributor saving precious time and efforts in creating all documents AFRESH. All technical and proprietary data, methods and formulations are confidential with NK and are not shared with any other party in the supply chain. Thus NKG is your RISK FREE Registration partner for an identified period.
Plus for the Indian Entity
We represent an Overseas Manufacturer in front of Regulatory Authorities and answer all questions related to the safety and quality of the products. You get your desired products in India at your doorstep without having to go through any Regulatory Hassles.
Preparing regulatory documents is a time consuming and meticulous exercise. As an importer or overseas manufacturer , one is already engrossed in various business aspects prior to placing the product in India. If a mistake is made, it can lead to complete delay in business plan, overheads, financial planning issues as well as supply chain disruption.
why nkg for IVD Services
NKG has a Dedicated and Efficient team of experienced regulatory professionals who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by providing clear and easily understandable requirements.
in numbers from
regulatory track record
5000+
INTERNATIONAL BRANDSRegistered
100k+
Products Registered
100%
transparency & trust
proudly SUPPORTING
trade commiSsions
NKG keeps in Close communications with various Trade Commissions, Business Chambers, embassies of many countries on various existing & new Rules & Regulations of government of India
member of
indian beauty & hygience association
our renowned
associates
contact nkg
we help you meet your compliance needs
NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.
