• 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

• 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

• Accountable to the Public through a Regulator

• Well run & managed

• Meet the legal obligations

• Delivery of Affordable low cost products

• 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: p

1) Syringes
2) Needles
3) I.V. Cannulas /Catheters
4) Contraceptives
5) Surgical Blades
6) Gloves

• 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

Strengths

Reliance on Factory Inspections for domestic producers
Access to pool of inspectors well versed with GMP w.r.t. Pharmaceutical Industry, Strong legal framework

Weakness

Limited/no knowledge of diverse nature of manufacturing technologies
Limited knowledge of regulating non sterile medical devices
Regulatory framework not developed , structured for medical devices
Lack of accredited Testing facilities for product conformity verification
No inspections for overseas manufacturers,
lacks transparency & guidance

Opportunities

Up gradation of Regulatory framework on GHTF guidelines
Facilitate Respect & Growth Of Indian industry

Threats

Non manufacturer Devices from Regulated may harm patients
Non Recognition by overseas regulators

If Things go wrong.......

• Regulations to provide non ambiguous legal requirements & guidance on best practices

• Reliance on preventing problems

• Evaluation of Risk & Hazard by MDR for suitable corrective action & preventive (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.

• 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/Dialog with MOH to assist in building regulatory framework

• 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

Path for the Regulator

• Improve transparency & dialog

• 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 p

• Recognize risk based classification of devices and need for variation in regulatory controls, premarket registration & approvals proportionate to these risks.

• Delegate supervision of conformity assessment to internationally accredited organizations with proven competencies