Apply for first FREE meeting with RIFC, BRBC

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Email *

This form is for applying for a FREE first meeting with the Regulatory Information and Facilitation Center (RIFC) to decide on the course of action. Meeting venue is NCL Innovation Park, Pune, India.

Name *

Contact Number *

Company Name *

Brief description of assistance required *

Is your device/ product is patented? *

Yes

Applied

Other:

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;

Yes

Is your device notified in India? *

(zi) “notified” means notified in the Official Gazette by the Central Government.

Yes

Maybe

Predicate device details (If applicable)

Write - 1.Brand Name, 2.Manufacturer name

Device Description *

Write Technology outline

INTENDED USE,
DESIGN,
ENERGY USED OR DELIVERED,
MATERIALS,
CHEMICAL COMPOSITION,
MANUFACTURING PROCESS,
PERFORMANCE,
BIOCOMPATIBILITY,
STANDARDS,
AND OTHER CHARACTERISTICS, AS APPLICABLE.
BRAND NAME

Class of the device - *

Class A

Class B

Class C

Class D

Not identified

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

Other:

Required

General advisory on specific queries

Submit

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