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Union of India - Section

Section 92 in The Medical Devices Rules, 2017

92. Rejection of application.

- If any document submitted by an applicant for grant of licence for import or manufacture or test licence or permit for personal use or permission to import or manufacture investigational medical device or new in vitro diagnostic medical device or permission to conduct of clinical investigation or clinical performance evaluation is found to be misleading, or fake, or fabricated, the application, after giving an opportunity to the applicant of being heard, shall be summarily rejected.