DIAGNOSTIC KIT REGULATORY SERVICES
PERMISSION TO MANUFACTURE OR PERMISSION FOR LOAN LICENSE TO MANUFACTURE CLASS A & B IVD KITS IN INDIA
IVD KITS which are manufactured need to be registered under the Medical Device Rules 2017. Under these rules, An application for seeking manufacturing permission must be submitted based on the risk class of the medical device to concerned authority.
In case of Class A & Class B IVD KITS , a manufacturer needs to apply for a permission or manufacturing license to the State Licensing Authority of the state where the manufacturing premises exist.
In Case a manufacturer wishes to apply for a Loan License to manufacture Class A & Class B IVD KITS, the manufacturer will need to submit an application for seeking permission to the State Licensing Authority of the state where the manufacturing premises exist.
As these are low to moderate risk IVD Kits, the regulatory mechanism for such products is short and less complicated.
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 PERMISSION TO MANUFACTURE OR PERMISSION FOR LOAN LICENSE TO MANUFACTURE CLASS A & B IVD IN INDIA FROM SLA 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 3- Application for Grant of Licence to Manufacture for Sale and Distribution of Class A or Class B medical device |
MD 5- Licence to Manufacture for Sale or for Distribution of Class A or Class B Medical Device. |
A & B |
Rs-5000 for plant registration Rs-500 for product (per product) |
SLA |
|
MD 4- Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device |
MD 6- Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device |
A & B |
Rs-5000 for plant registration Rs-500 for product (per product) |
SLA |
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 License to manufacture for sale and distribution of Class A & Class B IVD KITS in MD 5 , please click here.
For a checklist of documents required for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B IVD KITS MD 6, 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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5000+
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100%
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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.
