Canadian medical devices regulations, en, sor 98282, 022017. Regulatory requirements db orthodontics ensures that its orthodontic and dental products meet the european regulatory requirements detailed in mdd 9342eec, as amended by directive 200747ec, the united states medical device regulations 21 cfr part 820 and the canadian mdr sor 98 282 as applicable. Regulations are current to 20200421 and last amended on 20191216. June 8, 2011 notice global medical device consulting.
Legislation and guidelines medical devices acts and regulations the therapeutic products directorate tpd applies the food and drug regulations and the medical devices regulations under the authority of the food and drugs act to ensure that the pharmaceutical drugs and medical devices offered for sale in canada are safe, effective and of. The canadian medical devices regulations sor98282 apply to the manufacturing, sale, advertising for sale, and importation of medical. Health canada drug and medical device recall listings. Iso 485 what is being done to achieve global acceptance of. Medical devices regulations sor 98282 justice laws website.
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. Sor98282 medical devices regulations canada document. Sor 98282 may 7, 1998 dors 98282 le 7 mai 1998 food and drugs act loi sur les aliments et drogues medical devices regulations reglement sur les instruments medicaux p. Knowledge of iso 9001, iso 485, ivd directive 9879ec, 21 cfr 820, medical device regulations sor98282 and cgmp quality standards. Canada how to identify new and revised canadian medical device regulations. Medical devices regulations, sor98282 status in force since jul 01, 1998 main subjects exporting product safety quality management systems qms official title medical devices regulations, sor98282 extracted summary these regulations apply to a the sale and advertising for sale of a medical device. Regulations instruments medicaux medical devices reglement. Within the ul family of companies we provide a broad portfolio of offerings to all the medical device industries. Iso 485 what is being done to achieve global acceptance.
List of medical device regulatory documents published by health canada. Policy on the canadian medical devices conformity assessment. This act applies to all food, drugs, cosmetics and medical devices sold in canada, whether. Regulations for the monitoring of medical assistance in dying sor2018166 department of health act this act sets out the powers, duties and functions of the minister, which extend to all matters covering the promotion or preservation of the health of canadians over which parliament has jurisdiction. An empirical analysis of the legal frameworks governing. However, if the asp has purchased a medical device with which the asp is providing a service, the manufacturer of the device is still required to comply with the requirements of the medical devices regulations and obtain the appropriate licence prior to the sale to the asp. Regulations amending the medical devices regulations p. Manufacturers selling medical devices in canada must ensure that their medical devices meet the safety and effectiveness requirements as defined in this regulation. General requirements for basic safety and essential performance. His excellency the governor general in council, on the recommendation of the minister of health, pursuant to subsections 33, 301 and 371 footnote a of the food and drugs act, hereby makes the annexed medical devices regulations. Cmdr current as of february 21, 2006 medical devices regulations current as of february 21, 2006 sor98282 food and drugs act his excellency the governor general in council, on the recommendat ion of the minister of health, pursuant to subsections 33, 301 and 371a of the. Sor98282 archives document centers standards forum. Use of fda guidance materials to support canadian mdl. Regulations for the monitoring of medical assistance in dying sor 2018166 department of health act this act sets out the powers, duties and functions of the minister, which extend to all matters covering the promotion or preservation of the health of canadians over which parliament has jurisdiction.
The therapeutic products directorate tpd applies the food and drug regulations and the medical devices regulations under the authority of the food and drugs act to ensure that the pharmaceutical drugs and medical devices offered for sale in canada are safe, effective and of high quality. The canadian medical devices regulations sor98282 apply to the manufacturing, sale, advertising for sale, and importation of medical devices, including in vitro diagnostic devices. This includes certification, notified body and consultancy services. The tpd also administers fee regulations for drugs and. Materials and methods in order to identify and compare the legal frameworks governing genetic services labs across canadian provinces, we undertook a systematic empirical study for each province of the legal documents, both statutes and regulations, retrieved from the canadian legal electronic database canadian legal information institute canlii and the published literature obtained. Brief history of the canadian medical device regulatory. Regulatory requirements db orthodontics ensures that its orthodontic and dental products meet the european regulatory requirements detailed in mdd 9342eec, as amended by directive 200747ec, the united states medical device regulations 21 cfr part 820 and the. Canada gazette regulations amending the medical devices. Consumer products containing lead regulations sor201883. The canadian medical devices regulations sor 98282 apply to the manufacturing, sale, advertising for sale, and importation of medical devices, including in vitro diagnostic devices.
The manufacturer and importer of a medical device must make a preliminary and final report to the minister on any incident occurring inside or outside of canada and involving a device that is sold in canada. Sor98 282, 2012 consolidated edition, medical devices regulations canada iec 606011, consolidated edition 3. Links to acts and regulations for which health canada is responsible. Referred to by legislative instruments f2008l04337 tga referred to by sor98282 health canada 21 cfr part 820 harmonized with iso 485. Regulations since no sale of a medical device is taking place. Most documents listed below were published by health canada and are in pdf format. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, ul is. Canadian medical device regulatory regulations medical device.