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This form is for applying for a FREE half-hour first meeting with the Regulatory Information and Facilitation Center (RIFC) to decide on course of action. Meeting venue is NCL Innovation Park, Pune, India.
Contact Number/ (VC Ext. Number)
Brief description of assistance required
Is your device/ product is patented?
Is the device having predicate device? And claiming substantial equivalence to a predicate device?
(zm) “predicate device” means a device, first time and first of its kind, 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/ TECHNOLOGICAL CHARACTERISTICS as the device which is proposed for licence in India;
Is your device notified in India?
(zi) “notified” means notified in the Official Gazette by the Central Government.
Predicate device details (If applicable)
Write - 1. Brand Name, 2. Manufacturer name
Write Technology outline 1. INTENDED USE, 2. DESIGN, 3. ENERGY USED OR DELIVERED, 4. MATERIALS, 5. CHEMICAL COMPOSITION, 6. MANUFACTURING PROCESS, 7. PERFORMANCE, 8. BIOCOMPATIBILITY, 9. STANDARDS, 10. AND OTHER CHARACTERISTICS, AS APPLICABLE. 11. BRAND NAME
Class of the device -
Regulatory services required for,
Classification of the device
Material characterization/ Benchmark testing identification
Bio compatibility/ Biological evaluation identification
Pre-Clinical research/ testing identification
Clinical research requirements (Clinical Investigation/ Performance evaluation)
Grant of license to manufacture for sale and distribution
Grant of license to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training
Grant of permission to conduct clinical investigation of an investigational medical device
Grant of permission to conduct clinical performance evaluation of new in vitro diagnostic medical device
Grant of permission to import/manufacture for sale or for distribution of medical device which does not have predicate medical device
Grant of permission to import or manufacture for sale or for distribution of new in vitro diagnostic medical device
Post Market regulatory requirements
General advisory on specific queries
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