WORLD TRADE G/TBT/Notif.97.65
26February 1997
ORGANIZATION
(97-0817)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: CANADA
Ifapplicable, name oflocalgovernment involved (Articles 3.2and7.2):
2. Agency responsible: Department ofHealth
Agency orauthority designated tohandle comments regarding thenotification canbe
indicated ifdifferent from above:
3. Notified under Article 2.9.2 [X],2.10.1 [],5.6.2 [],5.7.1 [],other:
4. Products covered (HSorCCCN where applicable, otherwise national tariff heading.
ICSnumbers maybeprovided inaddition, where applicable): Medical devices
6. Description ofcontent: TheMedical Devices Regulations setouttherequirements
governing thesale,importation andadvertisement ofmedical devices. Thegoalofthe
Regulations istoensure thatmedical devices distributed inCanada arebothsafeand
effective.
Thepurpose ofthisamendment istoreplace theMedical Devices Regulations
which havebeeninforce since 1975, withanewsetofMedical Devices Regulations.
ThenewRegulations stemfrom a1991-1992 review oftheDepartments 's
Medical Devices Program (MDP) which recommended thattheMDP should focus on
regulating medical devices onariskassessment andriskmanagement basis. An
implementation planwasthendeveloped toactontherecommendations. Thatplanwas
founded ontwoprinciples: (1)Thatthelevel ofscrutiny afforded adevice should be
dependent upon theriskthatthedevice presents; and(2)thatthesafety and
effectiveness ofmedical devices canbestbeassessed through abalance ofquality
systems requirements, pre-market scrutiny andpost-market surveillance.
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Page2
6. Description ofcontent: (cont'd)
Indeveloping these Regulations, andconsistent withtherecommendations from
the1991-1992 review, theMDP conducted extensive examination andevaluation of
regulatory systems formedical devices inother jurisdictions (United States,
European Union, Japan and Australia). Emphasis was placed ondeveloping
requirements which areharmonious withthose ofourinternational trading partners and
eliminating, tothegreatest extent possible, requirements unique toCanada. Adoption of
harmonious Regulations inCanada will, ontheonehand, raise thelevel ofregulatory
scrutiny fordevices soldinCanada tolevels currently exercised inthecountries noted
above. Thiswillprovide greater assurance ofthesafety andeffectiveness ofmedical
devices sold inCanada. Ontheother hand, harmonization allows meaningful
negotiations towards Mutual Recognition Agreements (MRA) tooccur, thereby
eliminating barriers totrade. MRAs, onceoperational, willallow devices tobeassessed
inonejurisdiction andplaced onthemarket inallother jurisdictions party tothe
agreement without further assessment. Theelimination ofduplicative assessments also
hastheeffect ofsignificantly reducing compliance costs toboth industry and
Government andquicker access tomarkets fortheindustry. Itisunderstood thatthe
benefits ofMRAs willberealized inthelonger term duetothecomplexity ofthe
negotiations. TheMDP iscommitted toandsupported byindustry inachieving thisgoal
anditisthisfeature oftheRegulations, more thananyother, thatisappealing toand
supported bytheCanadian medical devices industry.
7. Objective andrationale: Protection ofhuman health andsafety.
8. Relevant documents: Canada Gazette, PartI,15February 1997
9. Proposed dateofadoption:
Proposed dateofentry intoforce:1August 1997
10. Final dateforcomments: 30April 1997
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: