DIAGNOSTIC KIT REGULATORY SERVICES
Permission to Manufacture or Import “NEW” IVD KIT MD 28 – MD 29
NEW IVD KITS
New In – Vitro Diagnostic Kits are diagnostic kits which have not been approved in Indian either for Import or Manufacture by the Central Licensing Authority i.e. CDSCO.
The predicate or similar products for such kits have not yet been approved by CDSCO.
“According to the new Medical Device Rules, 2017 “a “predicate device” is defined as a device, first time and first of its kind, which is approved for manufacture for sale or for import by the Central Licensing Authority and has the similar intended use, material of construction, and design characteristics as the device which is proposed for licence in India. An applicant filing for the import/manufacture of New In-Vitro Diagnostic kit which does not have a predicate IVD kit is required to submit substantial equivalence with the predicate device as a prerequisite for the submission of the application. A claim of substantial equivalence does not mean that the proposed medical device and predicate device are identical. Substantial equivalence shall be established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.”
As per the New Medical Devices Rules 2017 and Regulations, a Clinical Investigation specifically Clinical Performance Evaluation has to be administered to assess the safety and efficacy of the Proposed new IVD Kits.
In cases of New IVD Kits, classified under Class A, data on clinical performance evaluation may NOT be necessary depending on the nature of such IVD Kit.
As per Medical Device Rules 2017, Application seeking grant for Clinical Performance Evaluation of a NEW IVD KIT needs to be filed into CDSCO in FORM 24 and the approval to conduct the Clinical Performance Evaluation will be granted in FORM 25.
Once the safety and Efficacy of the IVD Kit is proved to be Safe for Indian population , an application for Import or Manufacture of this Diagnostic Kit has to be filled with the CDSCO on Online Portal SUGAM.
If after Clinical Performance Evaluation , it is found that the the proposed new IVD KIT is safe for use on Indian Population, then a Manufacturer or Importer can submit application for seeking grant of permission to Manufacture or Import the new IVD KIT in Form 28 and the corresponding approval will be granted in FORM 29.
Approval for NEW IVD Kits is a long and tedious regulatory procedure.
NKG experts are well versed with the New Medical Device rules and guidelines and have helped clients smoothen the regulatory processes and get approvals and permissions.
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 to Manufacture or Import “NEW” IVD KIT MD 28 – MD 29 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 24- Application for grant of permission to conduct clinical performance evaluation of new in vitro diagnostic medical device |
MD 25- Permission to conduct clinical performance evaluation of new in vitro diagnostic medical device |
B,C,D |
Rs-25000/- |
CDSCO |
|
MD 28- Application for grant of permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device |
MD 29- Permission to Import or Manufacture New In Vitro Diagnostic Medical Device |
B,C,D |
Rs-25000/- |
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 Permission to conduct Clinical Performance Evaluation of a “NEW” IVD KIT in FORM MD 24 – FORM MD 25, please click here.
For a checklist of documents required for grant of Permission to Manufacture or Import “NEW” IVD KIT MD 28 – MD 29, please click here.
FLOWCHART
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.
