DIAGNOSTIC KIT REGULATORY SERVICES
SERVICES FOR GRANT OF PERMISSION FOR TEST LICENSE TO IMPORT IVD KITS (FORM MD-16, FORM MD-17)
In case an Importer or manufacturer of an IVD KIT intends to import small quantities of an IVD KIT for the purpose of training or demonstration or clinical investigations or for the purpose of testing , an application in Form MD 16 for Test License to import such products can be submitted to CDSCO under the new Medical Device Rules 2017
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 test license on behalf of the overseas manufacturer.
Performance evaluation for certain Diagnostic Kits is mandatory from NIB Noida, India before grant of test license for import. CDSCO has specified such Diagnostic Kits. We assist our clients to obtain such a test license for samples.
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.
The technical team at NKG ABC guides applicants through this process and will help 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 categorised the notified categories of IVD Kits into 4 broad categories based on the risk classification of respective products. In order to seek PERMISSION FOR TEST LICENSE TO IMPORT IVD KITS it is important to note the categorisation 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 16- Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training |
MD 17- Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training |
A,B,C,D |
$100 |
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 Import License in MD 17.
For a checklist of documents required for seeking grant of Licence to Import IVD kits for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training, 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.
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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.
