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Apply for FREE first meeting
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.
Name *
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Contact Number/ (VC Ext. Number) *
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Company Name *
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Email *
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Brief description of assistance required *
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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
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Device Description *
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
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Class of the device - *
Regulatory services required for, *
Required
General advisory on specific queries
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