000	00000nam 2200000zi 4500
001	9.859830
003	CaOODSP
005	20221107160338
006	m     o  d f
007	cr |||||||||||
008	180730e201911##onc     o    f000 ||eng d
020	|a9780660274393
040	|aCaOODSP|beng|erda|cCaOODSP
043	|an-cn---
086	1 |aH13-9/20-2019E-PDF
245	00|aFees for the review of medical device licence applications : |bguidance document.
264	1|aOttawa, Ontario : |bHealth Canada = Santé Canada, |cNovember 2019.
264	4|c©2019
300	|a1 online resource (15 pages)
336	|atext|btxt|2rdacontent
337	|acomputer|bc|2rdamedia
338	|aonline resource|bcr|2rdacarrier
500	|aCover title.
500	|aIssued also in French under title: Frais pour l'examen des demandes d'homologations des instruments médicaux : ligne directrice.
500	|a"Effective date: 2020/04/01."
500	|aIssued also in HTML format.
520	|a"Before a medical device is authorized for sale in Canada, scientific evidence of its safety, efficacy and quality, as required by the Food and Drugs Act and Regulations, must be provided to Health Canada to determine whether the benefits associated with the product outweigh the risks. Health Canada has charged industry fees for these pre-market regulatory activities since 1998 in order to recover some of the associated costs"--Introduction, page 6.
650	0|aMedical instruments and apparatus industry|xLicenses|xFees|zCanada.
710	1 |aCanada. |bHealth Canada, |eissuing body.
775	08|tFrais pour l'examen des demandes d'homologations des instruments médicaux : |w(CaOODSP)9.859831
856	40|qPDF|s265 KB|uhttps://publications.gc.ca/collections/collection_2022/sc-hc/H13-9-20-2019-eng.pdf
856	4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/fees-review-medical-device-licence-applications-2019/document.html
986	|aPub.: 180196