Health Products and Food Branch Direction générale des produits de santé et des aliments The...

Health SantéCanada Canada

Health Products and Food BranchDirection générale des produits de santé et des aliments

The Canadian Medical Devices The Canadian Medical Devices Regulatory ProgramRegulatory ProgramCESO ConferenceCESO ConferenceApril 30, 2004April 30, 2004

Don BoyerDon Boyer

A/DirectorA/Director

Medical Devices Bureau, Therapeutic Products Medical Devices Bureau, Therapeutic Products Directorate, Health CanadaDirectorate, Health Canada

[email protected][email protected]



MEDICAL DEVICES BUREAUMEDICAL DEVICES BUREAU

MEDICAL DEVICES BUREAU MEDICAL DEVICES BUREAU

A d m in istra tio n O ffice rC a ro l H a yw a rd

A sso c ia te D ire c to rN a n cy R ich a rds

D e v ice E va lua tio n D iv is ionD r. Irw in H inb e rg (A c tin g )

D e v ice L ice n s in g D iv is ionN a n cy S ha d e ed (A ctin g )

D e v ice S u rve illa n ce D iv is ionD r. P h ilip N e u fe ld

Q u a lity S ys te m s U n itA n n e -M a rie C o u tu

D ire c to r (A c tin g )D o n B o yer

A sso c ia te D ire c to r G e n e ra lO m er B o u dre au

D ire c to r G e n e ra lD r. R . P e te rson



Goals of the Regulatory SystemGoals of the Regulatory Systemin Canadain Canada

risked based approachrisked based approach

post-market surveillancepost-market surveillance

global harmonizationglobal harmonization

international standardsinternational standards

quality systems approachquality systems approach

transparency and communicationtransparency and communication



Regulatory Provisions: EssentialsRegulatory Provisions: Essentials

Health Canada regulates the Health Canada regulates the advertising,advertising, manufacturemanufacture and and salesale of medical devices in of medical devices in Canada.Canada.

The Food and Drugs Act and Medical Devices The Food and Drugs Act and Medical Devices Regulations are the tools used to ensure that safe Regulations are the tools used to ensure that safe and effective devices are available.and effective devices are available.

Manufacturers of devices apply to Health Canada Manufacturers of devices apply to Health Canada to receive either a Licence or an Authorization to to receive either a Licence or an Authorization to sell their devices.sell their devices.



Regulatory Provisions: Essentials

Foundation of the Medical Devices Regulations

Degree of pre-market scrutiny based on the risk of a device

Balance of pre-market, post-market and quality system

Harmonize as much as much as possible with the regulatory approach of Canada’s international

trading partners



A manufacturer in the RegulationsA manufacturer in the Regulations sells a medical device under:sells a medical device under:

their own name, trade-mark, design, trade name or other name their own name, trade-mark, design, trade name or other name owned or controlled by the personowned or controlled by the person

is responsible for :is responsible for : designing, manufacturing, assembling, processing, labelling, designing, manufacturing, assembling, processing, labelling,

packaging,refurbishing or modifying the device, assigning it a packaging,refurbishing or modifying the device, assigning it a purposepurpose

performs or performs or has someonehas someone perform on their behalf perform on their behalf

Manufacturer = Name on the label

Regulatory Provisions: Essentials



Device Licence Class IIDevice Licence Class II

Identification information ISO 13488

Quality System

Certificate from CMDCAS "recognized"

auditing organization

Attestation of compliance with S&E, Intended Use/Purpose to verify Class, Application Type

+ +



Device Licence Class IIIDevice Licence Class III

Identification information

Same as Class II + label; list of "recognized" standards used in mfg; description of material in mfg and packaging; method of sterilization; summaries and conclusions of S&E studies; marketing history (#sold, where, problem reports and recalls)

+ +ISO 13485

Quality System

Certificate from CMDCAS "recognized" auditing organization



Device Licence Class IVDevice Licence Class IV

Identificationinformation

Same as Class II +label; risk assessment & risk reduction measures; quality plan;material specifications; Manufacturing process; Detailed information - S&E:

pre-clinical & clinical studiesprocess validation studiessoftware validation studiesliterature studies

ISO 13485Quality System+ +

Certificate from CMDCAS

"recognized" auditing organization



Licences Held by Country of Manufacture December 2003



Licences Renewed Annually



Medical Devices Regulatory Medical Devices Regulatory ProgramProgramKey ComponentsKey Components

Medical Devices Bureau – premarket review Medical Devices Bureau – premarket review of medical device licence applications, of medical device licence applications, Investigation Testing, Special Access Investigation Testing, Special Access Program, Regulatory Interpretation, Support Program, Regulatory Interpretation, Support to Post-market investigationsto Post-market investigations

Health Products and Food Branch Health Products and Food Branch Inspectorate – Compliance and Enforcement Inspectorate – Compliance and Enforcement – Establishment Licensing for Importers and – Establishment Licensing for Importers and DistributorsDistributors

Marketed Health Products Directorate – Marketed Health Products Directorate – Surveillance and Risk CommunicationSurveillance and Risk Communication



Medical Devices RegulationsMedical Devices RegulationsSection 26Section 26

…………..no person shall ..no person shall importimport or sell a Class II, III or sell a Class II, III or IV medical device unless the manufacturer of or IV medical device unless the manufacturer of the device holds a licence in respect of that the device holds a licence in respect of that device or, if the medical device has been device or, if the medical device has been subjected to a change described in section 34, subjected to a change described in section 34, an amended medical device licencean amended medical device licence

Importers / Distributors / Manufacturers of Class Importers / Distributors / Manufacturers of Class I devices not employing a “licensed” importer / I devices not employing a “licensed” importer / distributor require an distributor require an Establishment LicenceEstablishment Licence



Medical Devices BureauMedical Devices BureauCurrent IssuesCurrent Issues

December 2003 letter to hospitalsDecember 2003 letter to hospitals Evidence brought to Health Canada’s attention Evidence brought to Health Canada’s attention

indicates “unlicensed” medical devicesindicates “unlicensed” medical devices Letter makes two recommendations:Letter makes two recommendations:

Purchase only licensed devicesPurchase only licensed devices Conduct audit to ensure hospital is using licensed devicesConduct audit to ensure hospital is using licensed devices

Auditor General’s Report on Medical Devices Auditor General’s Report on Medical Devices Regulatory ProgramRegulatory Program




Medical Device Active Licence Listing Medical Device Active Licence Listing (MDALL)(MDALL)

www.mdall.cawww.mdall.ca::

All Class II, III and IV medical devices All Class II, III and IV medical devices “licensed” by Health Canada“licensed” by Health Canada

Contains information such as manufacturer’s Contains information such as manufacturer’s name, licence #, catalogue #name, licence #, catalogue #

QS requirements for manufacturers came into QS requirements for manufacturers came into force January 1, 2003 / November 1, 2003 force January 1, 2003 / November 1, 2003 (renewal) – major impact for industry and TPD(renewal) – major impact for industry and TPD




Reuse of Single-Use Devices (SUDs)Reuse of Single-Use Devices (SUDs) Reuse of Multiple-Use DevicesReuse of Multiple-Use Devices MDALL – only supplies information for currently MDALL – only supplies information for currently

valid licensed medical devices – no info on what valid licensed medical devices – no info on what was previously licensed, cancelled at renewal, was previously licensed, cancelled at renewal, suspended by HC, discontinued by manufacturersuspended by HC, discontinued by manufacturer

Delivery of healthcare is a “shared Delivery of healthcare is a “shared responsibility” – HC needs to develop effective / responsibility” – HC needs to develop effective / efficient partnerships with users / healthcare efficient partnerships with users / healthcare providersproviders



Bureau ContactsBureau Contacts

Bureau Director’s Office:Bureau Director’s Office:Don Boyer (613) 957-4786Don Boyer (613) 957-4786Associate Director’s OfficeAssociate Director’s OfficeNancy Richards (613) 946-6556Nancy Richards (613) 946-6556

Quality Systems:Quality Systems:Anne-Marie Coutu, (613) 954-0385Anne-Marie Coutu, (613) 954-0385Medical Device Licensing / Classification / Regulatory Medical Device Licensing / Classification / Regulatory Inquiries:Inquiries:Nancy Shadeed, (613) 954-0285Nancy Shadeed, (613) 954-0285Device Evaluation Division / ITA / SAP:Device Evaluation Division / ITA / SAP:Dr. Irwin Hinberg, (613) 954-0298Dr. Irwin Hinberg, (613) 954-0298Post-Market Surveillance:Post-Market Surveillance:Dr. Philip Neufeld, (613) 954-0288 Dr. Philip Neufeld, (613) 954-0288

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