Options for Regulation and the Options for Regulation and the Impact of Regulation on the Impact of Regulation on the

MarketplaceMarketplace

29 November 200529 November 2005

Alan KentAlan Kent

alan.kent@hillsborough7.freeserve.co.uk

Presentation OverviewPresentation Overview

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

Manufacturer’s TasksManufacturer’s Tasks

1.1. EstablishEstablish customer needs / specify the customer needs / specify the medical device’s intended use / identify medical device’s intended use / identify its risk its risk classificationclassification..

The documents published on the Global The documents published on the Global Harmonization Task Force web site (Harmonization Task Force web site (www.ghtf.org) provide guidance on this and other matters.

See guidance document See guidance document SG1(PD)/N015 SG1(PD)/N015 Principles of Medical Devices Principles of Medical Devices ClassificationClassification

Manufacturer’s TasksManufacturer’s Tasks

2.2. DesignDesign a device that is a device that is safesafe and performs as and performs as intended.intended.

See guidance document See guidance document GHTF/SG1/N41:2005GHTF/SG1/N41:2005 Essential Principles of Safety and Essential Principles of Safety and Performance of Medical DevicesPerformance of Medical Devices that that describes six general requirements of safety describes six general requirements of safety and performance that apply to and performance that apply to allall medical medical devices, and ………devices, and ………

continued …..continued …..

Manufacturer’s TasksManufacturer’s Tasks

lists requirements that apply to some lists requirements that apply to some medical device. For example:- chemical, medical device. For example:- chemical, physical and biological properties; physical and biological properties; infection and microbial contamination; infection and microbial contamination; manufacturing and environmental manufacturing and environmental properties; mechanical and electrical properties; mechanical and electrical properties etc..properties etc..

Prepare full technical documentation.Prepare full technical documentation.

Manufacturer’s TasksManufacturer’s Tasks

3.3. DesignDesign appropriate appropriate labellinglabelling (labels, (labels, instructions for use etc.).instructions for use etc.).

See guidance document GHTF/See guidance document GHTF/SG1/N43:2005 SG1/N43:2005 Labelling for Medical Devices.Labelling for Medical Devices.

4.4. DesignDesign to comply with relevant technical to comply with relevant technical standardsstandards..

See guidance document GHTF/See guidance document GHTF/SG1/N12:1999 SG1/N12:1999 Role of Standards in the Assessment of Role of Standards in the Assessment of Medical DevicesMedical Devices (Note: under review). (Note: under review).

Manufacturer’s TasksManufacturer’s Tasks

5.5. ManufactureManufacture device within an effective device within an effective Quality Management System (QMS) to Quality Management System (QMS) to ensure design input criteria are met on a ensure design input criteria are met on a consist basis.consist basis.

See GHTF guidance documents written See GHTF guidance documents written by Study Group 3 & relevant by Study Group 3 & relevant international standards.international standards.

Manufacturer’s TasksManufacturer’s Tasks

6.6. DemonstrateDemonstrate the device meets all relevant the device meets all relevant Essential Principles of Essential Principles of Safety & PerformanceSafety & Performance and complies with regulatory requirementsand complies with regulatory requirements.

See guidance document GHTF/See guidance document GHTF/SG1/N40 SG1/N40 Principles of Conformity Assessment for Principles of Conformity Assessment for Medical Devices Medical Devices (Note: Working draft).(Note: Working draft).

See guidance on clinical evidence see See guidance on clinical evidence see documents written by GHTF Study Group 5.documents written by GHTF Study Group 5.

Undertake and document a risk assessment Undertake and document a risk assessment for the device (see ISO 14971).for the device (see ISO 14971).

Options for Regulating These TasksOptions for Regulating These Tasks

Establish which products should be Establish which products should be controlled.controlled.

Establish & maintain a list of which Establish & maintain a list of which medical devices are in use nationally.medical devices are in use nationally.

Rely on overseas marketing authorization.Rely on overseas marketing authorization. Follow-up on adverse incident reports and Follow-up on adverse incident reports and

investigate any reports from Saudi Arabia.investigate any reports from Saudi Arabia. Audit QMS of any Saudi manufacturers.Audit QMS of any Saudi manufacturers. Introduce medical device regulations.Introduce medical device regulations.

Which Products Should Be Which Products Should Be Controlled?Controlled?

Government to decide which products are Government to decide which products are intended to fall within the scope of the intended to fall within the scope of the national controls and/or regulations?national controls and/or regulations?

Construct the appropriate definition of a Construct the appropriate definition of a ‘medical device’?‘medical device’?

Does it include Does it include in vitroin vitro diagnostic devices; diagnostic devices; aids for disabled people; disinfection aids for disabled people; disinfection substances; devices incorporating human substances; devices incorporating human and/or animal tissues; or accessories for and/or animal tissues; or accessories for medical devices? medical devices?

continued …..continued …..

Which Products Should Be Which Products Should Be Controlled?Controlled?

See See GHTF/SG1/N29:2005 GHTF/SG1/N29:2005 Information Information Document Concerning the Definition of the Document Concerning the Definition of the Term “Medical Device”.Term “Medical Device”.

Registration and Listing of Registration and Listing of Distributors, Manufacturers and Distributors, Manufacturers and

Medical DevicesMedical Devices Allows the Saudi DoH (Department of Health) Allows the Saudi DoH (Department of Health)

to know the medical devices that are in use to know the medical devices that are in use within its country; who distributes and within its country; who distributes and manufacturers them?manufacturers them?

Identifies the organisation responsible for Identifies the organisation responsible for device safety, performance, servicing and device safety, performance, servicing and maintenance?maintenance?

Clarifies the organisation responsible for any Clarifies the organisation responsible for any post-market action.post-market action.

continued …..continued …..

Registration and Listing of Registration and Listing of Distributors, Manufacturers Distributors, Manufacturers

and Medical Devicesand Medical Devices

Could provide income.Could provide income.

However,However,

Maintaining an accurate data base is time Maintaining an accurate data base is time consuming and resource intensive.consuming and resource intensive.

Relying on Overseas Marketing Relying on Overseas Marketing

AuthorizationAuthorization PROSPROS Utilises the expertise and controls of Utilises the expertise and controls of

overseas regulators.overseas regulators. Reduces local bureaucracy.Reduces local bureaucracy. Reduces the manufacturer’s cost of Reduces the manufacturer’s cost of

regulation and therefore product cost.regulation and therefore product cost. Probably brings medical devices into the Probably brings medical devices into the

local market more quickly than having a local market more quickly than having a local ‘barrier to trade’.local ‘barrier to trade’.

continued …..continued …..

Relying on Overseas Marketing Relying on Overseas Marketing AuthorizationAuthorization

CONSCONS Delays the development of local expertise Delays the development of local expertise

for medical devices.for medical devices. May be interpreted as failing to protect May be interpreted as failing to protect

public health fully.public health fully. May be exploited by disreputable May be exploited by disreputable

manufacturers and distributorsmanufacturers and distributors. . May discourage local industry.May discourage local industry.

Is There a Role for Testing Is There a Role for Testing

Medical Devices?Medical Devices? Manufacturers test prototype devices to Manufacturers test prototype devices to

ensure the design output matches the ensure the design output matches the technical specification. They may contract technical specification. They may contract with independent Test Houses to carry out with independent Test Houses to carry out this work.this work.

Thereafter, the manufacturer’s QMS should Thereafter, the manufacturer’s QMS should ensure all production units attain their ensure all production units attain their intended performance and safety intended performance and safety characteristics.characteristics.

continued …..continued …..

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

Mandatory testingMandatory testing as a step towards as a step towards gaining access to a local market is to be gaining access to a local market is to be avoided. avoided.

Instead, the DoH should rely upon post-Instead, the DoH should rely upon post-market adverse event reporting to identify market adverse event reporting to identify device problems after they have been device problems after they have been ‘placed on the market’.‘placed on the market’.

Why Track Adverse Events?Why Track Adverse Events?

Monitors the safety of medical devices Monitors the safety of medical devices that are already ‘placed in the market’.that are already ‘placed in the market’.

Develops expertise in medical devices Develops expertise in medical devices within the Saudi DoH.within the Saudi DoH.

Builds bridges to overseas Regulatory Builds bridges to overseas Regulatory Authorities.Authorities.

Prevents exploitation by disreputable Prevents exploitation by disreputable manufacturers and distributors.manufacturers and distributors.

Auditing the QMS of Any Saudi Auditing the QMS of Any Saudi Manufacturers.Manufacturers.

There will be some manufacturers of medical There will be some manufacturers of medical devices in Saudi Arabia if the GHTF devices in Saudi Arabia if the GHTF definition is adopted.definition is adopted.

They are likely to be low risk devices.They are likely to be low risk devices. If the policy is to encourage some moderate If the policy is to encourage some moderate

risk devices to be manufactured locally, risk devices to be manufactured locally, there is an opportunity to set up a QMS there is an opportunity to set up a QMS auditing function.auditing function.

See guidance documents from GHTF Study See guidance documents from GHTF Study Group 4.Group 4.

continued …..continued …..

Auditing the QMS of Saudi Auditing the QMS of Saudi Manufacturers.Manufacturers.

Internationally recognised Conformity Internationally recognised Conformity Assessment Bodies may be used with Assessment Bodies may be used with oversight by the Saudi DoH.oversight by the Saudi DoH.

PROSPROS Encourages local manufacturing.Encourages local manufacturing. Develops expertise in medical devices within Develops expertise in medical devices within

the Saudi DoH.the Saudi DoH. Safeguards public health.Safeguards public health. A stepping stone towards comprehensive A stepping stone towards comprehensive

regulations.regulations.

Objectives & ImplementationObjectives & Implementation

To safeguard public health.To safeguard public health. To ensure medical devices used in Saudi To ensure medical devices used in Saudi

Arabia are safe, of good quality and perform Arabia are safe, of good quality and perform as intended, whether they be locally as intended, whether they be locally manufactured or imported.manufactured or imported.

To introduce controls over a period of years To introduce controls over a period of years that will achieve these ends. that will achieve these ends. 

First to introduce progressively new controls, First to introduce progressively new controls, on a voluntary basis where possible, so as to on a voluntary basis where possible, so as to minimize the burden on industry.minimize the burden on industry.

Then to extend / amend existing legislation or Then to extend / amend existing legislation or introduce new statutes.introduce new statutes.

The Impact of Regulations on the The Impact of Regulations on the MarketplaceMarketplace

PROSPROS Develops expertise within Saudi Arabia Develops expertise within Saudi Arabia

and, thereby, safeguards public health.and, thereby, safeguards public health. Encourages local industry.Encourages local industry. Strengthens dialogue with other Strengthens dialogue with other

Regulatory Authorities.Regulatory Authorities. Could provide leadership within the Middle Could provide leadership within the Middle

East.East.continued …..continued …..

The Impact of Regulations on the The Impact of Regulations on the MarketplaceMarketplace

CONSCONS Increases the burden on industry – but to a Increases the burden on industry – but to a

minor extent if the ‘GHTF model’ is adopted. minor extent if the ‘GHTF model’ is adopted. The Saudi DoH will have to develop the The Saudi DoH will have to develop the

appropriate expertise and fund a new appropriate expertise and fund a new department.department.

Could be subordinate to a medicine’s Could be subordinate to a medicine’s regulatory body.regulatory body.

THANK YOUTHANK YOU