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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
Health SantéCanada Canada
Health Products and Food BranchDirection générale des produits de santé et des aliments
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
Health SantéCanada Canada
Health Products and Food BranchDirection générale des produits de santé et des aliments
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
Health SantéCanada Canada
Health Products and Food BranchDirection générale des produits de santé et des aliments
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.
Health SantéCanada Canada
Health Products and Food BranchDirection générale des produits de santé et des aliments
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
Health SantéCanada Canada
Health Products and Food BranchDirection générale des produits de santé et des aliments
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
Health SantéCanada Canada
Health Products and Food BranchDirection générale des produits de santé et des aliments
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
+ +
Health SantéCanada Canada
Health Products and Food BranchDirection générale des produits de santé et des aliments
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
Health SantéCanada Canada
Health Products and Food BranchDirection générale des produits de santé et des aliments
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
Health SantéCanada Canada
Health Products and Food BranchDirection générale des produits de santé et des aliments
Licences Held by Country of Manufacture December 2003
Health SantéCanada Canada
Health Products and Food BranchDirection générale des produits de santé et des aliments
Licences Renewed Annually
Health SantéCanada Canada
Health Products and Food BranchDirection générale des produits de santé et des aliments
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
Health SantéCanada Canada
Health Products and Food BranchDirection générale des produits de santé et des aliments
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
Health SantéCanada Canada
Health Products and Food BranchDirection générale des produits de santé et des aliments
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
Health SantéCanada Canada
Health Products and Food BranchDirection générale des produits de santé et des aliments
Medical Devices BureauMedical Devices BureauCurrent IssuesCurrent Issues
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
Health SantéCanada Canada
Health Products and Food BranchDirection générale des produits de santé et des aliments
Medical Devices BureauMedical Devices BureauCurrent IssuesCurrent Issues
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
Health SantéCanada Canada
Health Products and Food BranchDirection générale des produits de santé et des aliments
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