Options for Regulation and the Impact of Regulation on the Marketplace 29 November 2005 Alan Kent

Presentation Overview  Understanding the manufacturer’s 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.

Manufacturer’s Tasks 1.Establish customer needs / specify the medical device’s intended use / identify its risk classification.  The documents published on the Global Harmonization Task Force web site ( provide guidance on this and other matters.  See guidance document SG1(PD)/N015 Principles of Medical Devices Classification

Manufacturer’s Tasks 2.Design a device that is safe and performs as intended.  See guidance document GHTF/SG1/N41:2005 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 …..

Manufacturer’s 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.

Manufacturer’s Tasks 3.Design appropriate labelling (labels, instructions for use etc.).  See guidance document GHTF/SG1/N43:2005 Labelling for Medical Devices. 4.Design to comply with relevant technical standards.  See guidance document GHTF/SG1/N12:1999 Role of Standards in the Assessment of Medical Devices (Note: under review).

Manufacturer’s Tasks 5.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.

Manufacturer’s Tasks 6.Demonstrate the device meets all relevant Essential Principles of Safety & Performance and complies with regulatory requirements 6.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).

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.

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 …..

Which Products Should Be Controlled?  See GHTF/SG1/N29:2005 Information Document Concerning the Definition of the Term “Medical Device”.

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 …..

Registration and Listing of Distributors, Manufacturers and Medical Devices  Could provide income. However,  Maintaining an accurate data base is time consuming and resource intensive.

Relying on Overseas Marketing Authorization PROS  Utilises the expertise and controls of overseas regulators.  Reduces local bureaucracy.  Reduces the manufacturer’s 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 …..

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.

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 manufacturer’s QMS should ensure all production units attain their intended performance and safety characteristics. continued …..

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’.

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.

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 …..

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.

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.  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.

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 …..

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 medicine’s regulatory body.

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