Rajiv Nath, President, AISNMA Forum Coordinator,AIMED

 INDIA TO BE AMONG THE “ TOP 5” PREFFERED SOURCES IN EACH PRODUCT FAMILY OF MEDICAL DEVICES  INDIAN MEDICAL DEVICE REGULATORY AUTHORITY, A CENTRE FOR EXCELLENCE ASSISTING THE MEDICAL DEVICE INDUSTRY TO PRODUCE PRODUCTS WITH ADEQUATE AND APPROPRIATE CONTROLS AND SYSTEMS FOR ENSURING PATIENT SAFETY 2Ahmedabad Conference 2009

 Accountable to the Public through a Regulator  Well run & managed  Meet the legal obligations  Delivery of Affordable low cost products 3Ahmedabad Conference 2009

 Work with Industry in transparent manner  Supervise Directly / Through Accredited agencies  Aim to promote public trust in Indian Industry  Provide Guidance & Advice  to meet legal obligations  safety of consumers  Facilitate the Growth of Industry  Facilitate Introduction of Innovative & Emerging Technologies 4

 Medical Devices under Drugs & Cosmetics Act 1940  Treatment similar to Drugs/Medicines  Controlled & Inspected by  Drug Controller General India/CDSCO  State Drug Controller  Central/ State Laboratories  License Raj,undergoing review  Limited Knowledge/Competencies  Inspections, not standardized audits  Lack of acceptance of Risk based Assessment  New products/Technologies – Non existent product Standards 5Ahmedabad Conference2009

 Sterile Disposable Perfusion Sets - single use  Sterile Disposable Syringes – single use  Sterile Disposable Needles- single use  Copper T  Contraceptive Tubal Rings  Condoms made of Rubber  Surgical Ligature and Sutures  Surgical Dressings  Umbilical Tapes  Blood Bags Ahmedabad Conference 20096

 Cardiac Stents  Drug Eluting Stents  Catheters  Intraocular Lens  IV Cannulae  Bone Cement  Heart Valve  Scalp vein Set  Orthopedic Implants  Internal Prosthetic Replacements Ahmedabad Conference 20097

 Founded in 1992 by Canada, EU, Japan, USA, Australia  Informal Grouping of medical device regulators & industry  To encourage convergence in regulatory practices related to ensuring the safety, effectiveness/performance and quality of medical devices,promoting technological innovation and facilitating international trade  By publication of harmonized guidance documents on basic regulatory practices Ahmedabad Conference 20098

 Formed in 1996 by an informal group of experts from regulatory authorities, CAB s & industry  To forge a common direction for harmonization of medical device regulation in Asia  Encourage understanding on benefits of harmonization and facilitate a linkage with the GHTF  Provide a forum for discussion & training Ahmedabad Conference 20099

IMDRRG Indian Medical Devices Regulatory Review Group

 Model based on GHTF guidelines & EU – MDD  Medical Devices are not Medicines  Safety Assurance through Risk Based Classification  Class based Conformity assessment procedures :ISO 13485/ IS  Notified Conformity Assessment Bodies  Clinical Investigation : ISO  Adverse Event reporting  Regulator & CAB with powers to enforce corrective action Ahmedabad Conference

ClassRisk Level A (I)Low Risk B (II a)Low- Moderate Risk C (II b)Moderate- High Risk D (III)High Risk Ahmedabad Conference

 Class A - Manufacturer will register with CLAA - Manufacturing license not required  Class B – Manufacturers Quality Management System to be assessed and certified by a notified body - Manufacturer will be registered with the CLAA on the basis of certificate from notified body - Manufacturing License not required  Class C – Certification by a notified body is required with regard to the design & manufacture of the device -manufacturer to apply for manufacturing license to CLAA with supporting documents wrt safety & efficacy of device -Manufacturing license to be issued by CLAA on the basis of above documents and certificate issued by CAB  Class D – As ‘C’ above+ Factory will be jointly inspected by CLAA & State licensing authority, MFG LIC based on report + Certificate from Notified body 13

 Quality Management System  Manufacturing Facility Compliance  Process Approach – Model, 8 Broad Sections  Activities – Quality Plan, Quality Objectives, Internal Audits,Corrective & Preventive Action, independent external audits & Tests  Enables Response to External issues- customer complaints/ feedback,regulatory or Internal issues-facilities, process up gradation or training and competency of personnel Ahmedabad Conference

 ISO Analysing, Evaluating & Controlling Risks  Develop risk management plan  Failure Mode & Effects Analysis (FMEA)  Fault Tree Analysis (FTA)  Identification of Hazard  Preliminary Risk Assessment  Risk Mitigation  Residual Risk evaluation Ahmedabad Conference

 1) Free Sales Certificate Issue - Informal Registration Information -ISO13485/CE certification -Prior History of Mfg/ Exports -Informal cursory inspection to validate -Free Sales Certificate Issuance -Undertaking to Fulfill Licensing Requirements  2) ISO QMS in transition period instead Schedule M/MIII Ahmedabad Conference

 Grant of license, registration & fees on basis of product family  Brand Permission to be changed to Additional Brand information if identical product  Parametric Release if Process validated for EO sterilization & Pharmacopeia Review  Guideline for minor/major NCR for substandard devices & BIS/ISO/Co. standard  Training of Regulators with Industry Inputs  Standardize Formats –Non Conviction, Market Standing & Performance Certificates Ahmedabad Conference200917

 Majority Exporting units comply with ISO13485 and Certificate/Registration with GHTF countries  Moving up the Value Chain  Moving up the Quality & Technology Ladder  “Top 5” Preferred Source Status achieved in: 1)Syringes 7) Intraocular Lens 2)Needles 3)I.V. Cannulas /Catheters 4)Contraceptives 5)Surgical Blades 6)Gloves 18Ahmedabad Conference 2009

 Upgrade:  manufacturing & testing facilities  management competencies  quality management systems  Get ISO certification from internationally accredited organizations  Get registration and certification from a GHTF member country  Self regulation/ Continue Dialog with MOH to assist in building regulatory framework 19Ahmedabad Conference 2009

 Continue the Improved transparency & dialog  Continue to Involve Industry in creating a mutually acceptable Regulatory Framework & Infrastructure.  Ensure timely response to guidance/ advice sought on clarifications of compliances  Constitute expert committees on various aspects  Define milestones for phased creation of a regulatory infrastructure & implementation 20Ahmedabad Conference 2009

 Regulations to provide non ambiguous legal requirements & guidance on best practices  Reliance on preventing problems  Evaluation of Risk & Hazard by MDR for suitable corrective & preventive action (CAPA)  Reasonable time for addressing issues and implementing CAPA  Regulator to have powers for putting things right  Minimal/No reliance of judiciary and legal criminal action on registered units  Reliance of Judiciary/ Police and criminal action only on non registered units. 21Ahmedabad Conference 2009

 Lack of trust and dialog  Lack of time bound response to queries  Reliance on Tests, inspections, arbitrary controls  Draconian punitive action  Unreasonable expectations  Lack of clarity of superseded rules/requirements and standards  Conformity assessment organizations acting as consultants / trainers to same assesses 22Ahmedabad Conference 2009

Thank You! Lets Work in Partnership to achieve The Millennium Development Goals 23Ahmedabad Conference 2009