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8/3/2019 Regulatory India Synthes Medical Pvt Ltd
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Regulatory Affairs
India
Synthes Medical Pvt LtdPresented by:
Vivek Malhotra (AM Regulatory Affairs)9 November 2011
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Contents
Regulatory Organogram Synthes India
Regulatory Authority in India
Regulatory approval process Fees
List of documents required
Re-Registration Clinical trial Regulatory
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Regulatory Organogram Synthes
India
VIVEK MALHOTRAAssistant ManagerRegulatory Affairs
ANIL DEWANFinance Director
STARK STEFANIEManager RA
Asia Pacific
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Indian Regulatory Authority
CDSCO regulates medical devices registration and import. CDSCO is controlled by theDrug Controller General India (DCGI).
Foreign manufacturers must apply for registration certification for their manufacturing
premises and for the individual devices to be imported from the registered site.
Applications can be made by Indian subsidiary / authorized agents of foreign firms in
India.
Import license applications should be made using Form 40 and information and
undertakings specified in Schedule D(I) and Schedule D(II) should be duly signed by
the manufacturer. For new device registration form 44 is also included.
The process of receiving import registration can take up to 9-11 months (6-8 months
for registration and 2-3 months for Import permit) for new registration and 5-6
months for change notification or re-registration. Once we have import registration
(valid for three years) for a drug, we can apply for a simple import license via Form 8
and Form 9, which is needed for customs clearance.
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Regulatory Authority Organogram
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Regulatory work flow
CDSCO office of DCGI
Stark, Stefanie -Switzerland,
Waldenburg
Synthes India
Regulatory
Deficiency Letter
Approval letter
4-5 Months
Submitted via liasioning agent
Apply for import license using Form 8, pay applicable fees to CDSCO and obtain Import License Form 9.
6 Months
2-3 Months
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Registration Required
Manufacturing site registration
Medical Device registration
Import license for the registered device
Wholesale and warehouse license.
Indian HA website
http://cdsco.nic.in/Medical_div/medical_device_ division.htm
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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.
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List of documents requiredApplication/Cover Letter Cover letter Power of Attorney, signed stamped and Notarized Form 40 Wholesale drug License (Form 20B and Form 21B) notarized copy and form 41. Registration fees for 1000USD
Volume I (Legal Documents)
Schedule DI and Schedule DII Free Sale Certificate ISO 13485:2003 Full Quality assurance certificate Declaration of Conformity Date first sold and country name Complaint Stats (PMS) Instructions For Use (IFU) Price in the country of Origin
Volume II Sterilization and Shelf life documents
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List of documents required for Registration
Volume III Essential Requirements Checklist Label Master Document Clinical Evaluation Manufacturing Flowchart Functional & Design Requirements and Verification & Validation
Matrix First Article inspection Biocompatibility Risk Management Post Marketing Surveillance
Volume IV
Literature
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Approval letter
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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.
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Clinical TrialsClinical trials guidelines are given in Scheudle Y of Drugs andCosmetics Act 1945
Schedule Y, the current regulator (CDSCO – Central Drugs StandardControl Organization) enforced law in India has been establishedunder Drugs and Cosmetic Act 1945.
The regulations to be followed when conducting clinical trials in Indiaare 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 in1995. Since then multiple revisions to schedule Y took place to providea healthy environment for clinical research to be conducted in India
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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)
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Clinical TrialFee 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
CTRI approval takes one week.
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Clinical Trial
Application requirements1 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 Investigator’s Undertaking
8 Ethics Committee Approval
9 Informed Consent Form
10 Case Record Form
11 Patient Record Form
12 Relevant Published Literature13 Investigator’s 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
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THANK YOU
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