DIAGNOSTIC KIT REGULATORY SERVICES
Permissions for Test License to Manufacture IVD KITS in MD 12 – MD 13
In case the manufacturer of a Diagnostic Kit or IVD KIT intends to Manufacture small quantities of such a kit for the purpose of training or demonstration or clinical investigations or for the purpose of testing , an application for Test License to manufacture such products can be submitted to CDSCO under the new Medical Device Rules 2017.
The new Medical Device Rules 2017 require the manufacturer to obtain a test license by applying for it using Form MD-12. Further, the test license for manufacturing IVD KITS for above mentioned purposes will be granted as permission through Form-13.
The test license for such IVD Kits will be granted by the licensing authority to a manufacturer with a clear purpose stating “ Not for sale or Commercial Use”
NKG experts understand that notified as well as non notified Kits need to be tested from time to time. We have been providing accurate dossier support and filing services to help our clients get their necessary approvals.
The technical team at NKG ABC guides applicants through this process and will helps them in obtaining the respective test license for medical device imports for the above mentioned purposes.
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 seek Permissions for Test License to manufacture Medical Devices it is important to note the categorization and correct forms 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 12- Application for licence to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training |
MD 13- Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training |
A,B,C,D |
$500 |
CDSCO |
Regulatory Documents:
A comprehensive checklist of documents has been issued by the regulatory authority which needs to be submitted for processing and grant of above permissions.
For a checklist of documents required for grant of Permissions for Test License to manufacture Medical Devices for the purpose of training or demonstration or clinical investigations or for the purpose of testing in MD 13, 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
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.
