Options for Regulation and the Impact of Regulation on the Marketplace

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Options for Regulation and the Impact of
Regulation on the Marketplace

• 29 November 2005
• Alan Kent
• alan.kent_at_hillsborough7.freeserve.co.uk

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Presentation Overview

• Understanding the manufacturers tasks.
• Options for regulating these tasks.
• Which products should be controlled?
• Registration and listing.
• Relying on overseas marketing authorization.
• Is there a role for testing medical devices?
• Why track adverse events?
• Auditing the QMS of Saudi manufacturers.
• Regulatory objectives and implementation.
• The impact of regulation on the marketplace.

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Manufacturers Tasks

• Establish customer needs / specify the medical
  devices intended use / identify its risk
  classification.
• The documents published on the Global
  Harmonization Task Force web site (www.ghtf.org)
  provide guidance on this and other matters.
• See guidance document SG1(PD)/N015 Principles of
  Medical Devices Classification

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Manufacturers Tasks

• Design a device that is safe and performs as
  intended.
• See guidance document GHTF/SG1/N412005 Essential
  Principles of Safety and Performance of Medical
  Devices that describes six general requirements
  of safety and performance that apply to all
  medical devices, and

continued ..
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Manufacturers Tasks

• lists requirements that apply to some medical
  device. For example- chemical, physical and
  biological properties infection and microbial
  contamination manufacturing and environmental
  properties mechanical and electrical properties
  etc..
• Prepare full technical documentation.

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Manufacturers Tasks

• Design appropriate labelling (labels,
  instructions for use etc.).
• See guidance document GHTF/SG1/N432005
  Labelling for Medical Devices.
• Design to comply with relevant technical
  standards.
• See guidance document GHTF/SG1/N121999 Role of
  Standards in the Assessment of Medical Devices
  (Note under review).

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Manufacturers Tasks

• Manufacture device within an effective Quality
  Management System (QMS) to ensure design input
  criteria are met on a consist basis.
• See GHTF guidance documents written by Study
  Group 3 relevant international standards.

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Manufacturers Tasks

• Demonstrate the device meets all relevant
  Essential Principles of Safety Performance and
  complies with regulatory requirements.
• See guidance document GHTF/SG1/N40 Principles of
  Conformity Assessment for Medical Devices (Note
  Working draft).
• See guidance on clinical evidence see documents
  written by GHTF Study Group 5.
• Undertake and document a risk assessment for the
  device (see ISO 14971).

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Options for Regulating These Tasks

• Establish which products should be controlled.
• Establish maintain a list of which medical
  devices are in use nationally.
• Rely on overseas marketing authorization.
• Follow-up on adverse incident reports and
  investigate any reports from Saudi Arabia.
• Audit QMS of any Saudi manufacturers.
• Introduce medical device regulations.

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Which Products Should Be Controlled?

• Government to decide which products are intended
  to fall within the scope of the national controls
  and/or regulations?
• Construct the appropriate definition of a
  medical device?
• Does it include in vitro diagnostic devices aids
  for disabled people disinfection substances
  devices incorporating human and/or animal
  tissues or accessories for medical devices?
• continued ..

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Which Products Should Be Controlled?

• See GHTF/SG1/N292005 Information Document
  Concerning the Definition of the Term Medical
  Device.

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Registration and Listing of Distributors,
Manufacturers and Medical Devices

• Allows the Saudi DoH (Department of Health) to
  know the medical devices that are in use within
  its country who distributes and manufacturers
  them?
• Identifies the organisation responsible for
  device safety, performance, servicing and
  maintenance?
• Clarifies the organisation responsible for any
  post-market action.

continued ..
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Registration and Listing of Distributors,
Manufacturers and Medical Devices

• Could provide income.
• However,
• Maintaining an accurate data base is time
  consuming and resource intensive.

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Relying on Overseas Marketing Authorization

• PROS
• Utilises the expertise and controls of overseas
  regulators.
• Reduces local bureaucracy.
• Reduces the manufacturers cost of regulation and
  therefore product cost.
• Probably brings medical devices into the local
  market more quickly than having a local barrier
  to trade.

continued ..
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Relying on Overseas Marketing Authorization

• CONS
• Delays the development of local expertise for
  medical devices.
• May be interpreted as failing to protect public
  health fully.
• May be exploited by disreputable manufacturers
  and distributors.
• May discourage local industry.

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Is There a Role for Testing Medical Devices?

• Manufacturers test prototype devices to ensure
  the design output matches the technical
  specification. They may contract with
  independent Test Houses to carry out this work.
• Thereafter, the manufacturers QMS should ensure
  all production units attain their intended
  performance and safety characteristics.

continued ..
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Is There a Role for Testing Medical Devices?

• Mandatory testing as a step towards gaining
  access to a local market is to be avoided.
• Instead, the DoH should rely upon post-market
  adverse event reporting to identify device
  problems after they have been placed on the
  market.

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Why Track Adverse Events?

• Monitors the safety of medical devices that are
  already placed in the market.
• Develops expertise in medical devices within the
  Saudi DoH.
• Builds bridges to overseas Regulatory
  Authorities.
• Prevents exploitation by disreputable
  manufacturers and distributors.

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Auditing the QMS of Any Saudi Manufacturers.

• There will be some manufacturers of medical
  devices in Saudi Arabia if the GHTF definition is
  adopted.
• They are likely to be low risk devices.
• If the policy is to encourage some moderate risk
  devices to be manufactured locally, there is an
  opportunity to set up a QMS auditing function.
• See guidance documents from GHTF Study Group 4.

continued ..
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Auditing the QMS of Saudi Manufacturers.

• Internationally recognised Conformity Assessment
  Bodies may be used with oversight by the Saudi
  DoH.
• PROS
• Encourages local manufacturing.
• Develops expertise in medical devices within the
  Saudi DoH.
• Safeguards public health.
• A stepping stone towards comprehensive
  regulations.

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Objectives Implementation

• To safeguard public health.
• To ensure medical devices used in Saudi Arabia
  are safe, of good quality and perform as
  intended, whether they be locally manufactured or
  imported.
• To introduce controls over a period of years that
  will achieve these ends. 
• First to introduce progressively new controls, on
  a voluntary basis where possible, so as to
  minimize the burden on industry.
• Then to extend / amend existing legislation or
  introduce new statutes.

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The Impact of Regulations on the Marketplace

• PROS
• Develops expertise within Saudi Arabia and,
  thereby, safeguards public health.
• Encourages local industry.
• Strengthens dialogue with other Regulatory
  Authorities.
• Could provide leadership within the Middle East.

continued ..
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The Impact of Regulations on the Marketplace

• CONS
• Increases the burden on industry but to a minor
  extent if the GHTF model is adopted.
• The Saudi DoH will have to develop the
  appropriate expertise and fund a new department.
• Could be subordinate to a medicines regulatory
  body.

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THANK YOU