Rajiv Nath , President , AISNMAForum 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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IMDRRGIndian 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

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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 CertificatesAhmedabad Conference2009 17

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) Needles3) I.V. Cannulas /Catheters4) Contraceptives5) Surgical Blades6) 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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Thank You!

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