In case of investigational medical device or new In Vitro diagnostic medical device, the applicant shall obtain prior permission in Form MD-29 from the Central Licensing Authority.
Provided that the new In Vitro Diagnostic medical device used for diagnosis of life threatening, serious diseases or diseases of special relevance to the Indian health scenario, national emergencies, extreme urgency, epidemic and diagnostic medical devices used for diagnosis of conditions, diseases for which there is no diagnostic medical device available in the country, the clinical data requirements may be abbreviated, deferred or omitted, as deemed appropriate by the Central Licensing Authority.
An applicant shall submit the Periodic Safety Update Report to the Central Licensing Authority from the date of launch in the market and such report shall be submitted every six months for first two years followed by submission of the said report annually for the two more successive years.
Also, the permission holder shall inform the date of launch of IVD in the market to the Central Licensing Authority along with the suspected unexpected serious adverse event within fifteen days of the awareness of the event to the Central Licensing Authority.
Provided further that for new In Vitro Diagnostic medical device classified under Class A, data on clinical performance evaluation may not be necessary. The authority under sub-rule (1), may grant permission to import or manufacture new In Vitro Diagnostic medical device in Form MD-29 or may reject the application, within a period of ninety days, from the date of application.
An application for the grant of permission to conduct, clinical performance evaluation of new in vitro diagnostic medical device shall be made to the Central Licensing Authority in Form MD-24. We at CliniExperts, help in the initiation and management of a clinical investigation or clinical performance evaluation in India.
In case of new In vitro Diagnostic Kit, the applicant shall obtain prior permission in Form MD-29 from the Central Licensing Authority and no licence to import any class of such IVD shall be granted without such permission.
An applicant filing an application for import or manufacture of the intended IVD which does not have a predicate IVD , after completion of its Clinical Performance Evaluation shall be made to the Central Licensing Authority in Form MD-29 either by an authorised agent in case of import or a manufacturer, as the case may be, which shall be accompanied with fee as specified.
We at CliniExperts enable our clients to obtain the Permission to import/manufacture New In-Vitro Diagnostic which does not have a predicate kit swiftly.