Professional Documents
Culture Documents
Contents
Regulatory Organogram Synthes India Regulatory Authority in India Regulatory approval process Fees List of documents required Re-Registration Clinical trial Regulatory
6 Months
Approval letter
Deficiency Letter
2-3 Months
Apply for import license using Form 8, pay applicable fees to CDSCO and obtain Import License Form 9.
Registration Required
Manufacturing site registration Medical Device registration Import license for the registered device Wholesale and warehouse license.
Fees
A fee of US $ 1500 (US $ One Thousand Five Hundred only) for registration of premises A fee of US $ 1000 (US $ One Thousand only) for registration of Medical Devices for import Re Registration fees after 3 years for every Medical Device and premises.
Approval letter
Re-Registration
Registration is valid for a period of 3 years. The Re-Registration application is filled after three years. The process and fee structure of Re-Registration remains the same as for initial registration.
Clinical Trials
Clinical trials guidelines are given in Scheudle Y of Drugs and Cosmetics Act 1945 Schedule Y, the current regulator (CDSCO Central Drugs Standard Control Organization) enforced law in India has been established under Drugs and Cosmetic Act 1945.
The regulations to be followed when conducting clinical trials in India are clearly documented to a large extent in this document. Schedule Y for India is a law and not a mere guideline.
Schedule Y in line with ICH-GCP (International Council of Harmonization and Good Clinical Practice) standard was put forth in 1995. Since then multiple revisions to schedule Y took place to provide a healthy environment for clinical research to be conducted in India
Clinical trial
Approvals and Registration need: NOC/Approval to conduct a clinical trial Approval to import the test drug Approval/NOC to export biological samples Registration of trial on CTRI website (Indian version for clinicaltrial.gov)
Clinical Trial
Fee
I. For Feasibility Study (i.e. Safety and efficacy study); which is equivalent to Phase I trials in case of drugs: Rs 50, 000/II. For Pivotal Study (i.e. Confirmatory trials); which is equivalent to Phase II/III trials in case of drugs: Rs 25, 000/-
Timelines
Clinical Trial
Application requirements
1 Covering Letter 2 Form 44, Import Lic application and Export NOC application. 3 Fee in TR6 challan 4 Delegation of Responsibility 5 Protocol 6 Global Regulatory Status of the Device and clinical trial. 7 Investigators Undertaking 8 Ethics Committee Approval 9 Informed Consent Form 10 Case Record Form 11 Patient Record Form 12 Relevant Published Literature 13 Investigators Brochure 14 Suspected Unexpected Serious Adverse Reaction (SUSAR) 15 Affidavit from the sponsor 16 Any other specific relevant information 17 Clinical Study Report, if any
THANK YOU