DIAGNOSTIC KIT REGULATORY SERVICES
Permission for Import License (Form MD-14, Form MD-15)
IVD Devices which are imported need to be registered under the Medical Device Rules 2017. An application for Import License in MD 14 needs to be submitted to CDSCO by an authorised agent who has been appointed by a Power of Attorney.
The Appointed agent must have a license for stock and sale in Form 20 b & 21 B for sale and distribution issued under Medical Device Rules 2017, before applying for an application for import license on behalf of the overseas manufacturer.
NKG also holds a valid stock and sale license (Form 20B and 21B) to assist foreign manufacturers to import their IVD Kits in India in less time and without any hassle. Hence speeding up their business ventures.
Application Form :
The new Medical Device Rules 2017, have categorized the notified categories of IVD Kits into 4 broad categories based on the risk classification of respective products. In order to apply for an Import License in MD 14, it is important to understand the categorization so that we can ascertain the correct fee structure applicable for the grant of approval. The below table suggests that application form , approval form, fee structure based on the risk class of products.
|
Application Form |
Approval Form |
Risk/Class A,B,C,D |
Fees |
Licensing Authority |
|
MD 14- Application for issue of import licence to import medical device In Class A or B (In vitro) |
MD 15- Licence to Import Medical Device In Class A or B (In vitro) |
A & B |
$ 1000 for plant $ 10 for product (per product) |
CDSCO |
|
MD 14- Application for issue of import licence to import medical device In Class C or D (In vitro) |
MD 15- Licence to Import Medical Device In Class C or D (In vitro) |
C & D |
$ 3000 for plant $ 500 for product (per product) |
CDSCO |
Regulatory Documents:
A comprehensive checklist of documents has been issued by the regulatory authority as per Fourth schedule Part I, Part II and Part III (Appendix I & III, only) which needs to be submitted for processing and grant of Import License in MD 15.
For a checklist of documents required for seeking grant of Import License in MD 15 , please click here.
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 regulatory gaps, 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
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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.
