Regulatory India Synthes Medical Pvt Ltd

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



Contents

Regulatory Organogram Synthes India

Regulatory Authority in India

Regulatory approval process Fees

List of documents required

Re-Registration Clinical trial Regulatory



Regulatory Organogram Synthes

India

VIVEK MALHOTRAAssistant ManagerRegulatory Affairs

ANIL DEWANFinance Director

STARK STEFANIEManager RA

Asia Pacific



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.



Regulatory Authority Organogram



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



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

http://cdsco.nic.in/Medical_div/medical_device_division.htm






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.



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



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



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 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



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 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.



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



THANK YOU