Indian Medical Device Regulation by fjhuangjun

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									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


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




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   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


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   18-20 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


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   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

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

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   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
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   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


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                                 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 15579
   Notified Conformity Assessment Bodies
   Clinical Investigation : ISO 14155
   Adverse Event reporting
   Regulator & CAB with powers to enforce
    corrective action
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Class      Risk Level
A (I)      Low Risk
B (II a)   Low- Moderate Risk


C (II b)   Moderate- High Risk


D (III)    High Risk




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   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
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   ISO 14971-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


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   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 13485 QMS in transition period instead
        Schedule M/MIII

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   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

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    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

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   Upgrade:
   manufacturing & testing facilities
   management competencies
   quality management systems
   Get ISO 13485 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

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   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

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   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.



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   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

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Lets Work in Partnership to achieve
The Millennium Development Goals
                                          Thank You!



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