Medical devices regulations, sor98282, retrieved on 20200426. Regulations are current to 20200319 and last amended on 20190617. Medical devices regulations 555 kb regulations are current to 20200305 and last amended on 20191216. His excellency the governor general in council, on the recommendation of the minister of health, pursuant to subsections 33, 301 and 371 a of the food and drugs act, hereby makes the annexed medical devices regulations.
Canadian medical devices regulations, en, sor 98282, 022017. One of the most frustrating things about the canadian medical device regulations cmdr, sor 98 282, is the difficulty in identifying what has changed since the previous revision. Medical device regulations from health canada emergo. The canadian medical devices regulations sor 98 282 apply to the manufacturing, sale, advertising for sale, and importation of medical devices, including in vitro diagnostic devices. Sor 98 282 medical devices regulations canada complete current edition. Commission recommendation 98 282 ec on the ways in which the member states and the signatory states to the agreement on the european economic area should protect intellectual property in connection with the development and manufacture of flavouring substances referred to in regulation ec no 223296 of the european parliament. Manufacturers selling medical devices in canada must ensure that their medical devices meet the safety and effectiveness requirements as defined in this regulation. Subsections 311 and 3 of the legislation revision and. What does sor and dors stand for in the medical devices. Drugs and narcotics veterinary use fees regulations sor985. Medical devices regulations sor98282 latest consolidated version. Transition to the revised version of iso 485, en, 16108859627, 082016.
Notices and early consultation there are no current notices or early. Consumer products containing lead regulations sor201883. Regulations are current to 20200402 and last amended on 20191216. Sor98282 medical devices regulations canada document. Medical devices regulations 555 kb regulations are current to 20200319 and last amended on 20191216. Army publishing directorate army publishing directorate. The canadian medical devices regulations sor98282 apply to the. From the list of schedules, write down the sor number of the desired.
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