Orca1

Data catalog

Health Canada regulation sections cited in inspections

About 273 records

All records

Every Health Canada citation record published by Orca1, 1000 per page. Each page lists the record id and its name; open a record for key facts, related records and what Orca1 adds.

  1. blood-regulationsBlood regulations
  2. Blood regulations - blood regulations
  3. c-01-000-and-or-c-08-000C.01.000 and/or c.08.000
  4. C.01.000 and/or c.08.000 - gvp sections
  5. C.01.017 - serious adverse drug reaction reporting
  6. C.01.018 - annual summary report and case reports
  7. C.01.019 - issue-related summary report
  8. C.01.020 - maintenance of records
  9. C.01.050 - notification of a foreign action
  10. C.01.050 - notify of a serious risk of injury to human health
  11. C.01.050 - notify of a serious risk to human health
  12. c-02-000C.02.000
  13. c-02-0004-premisesC.02.0004- premises
  14. c-02-000-gmp-sectionsC.02.000 - gmp sections
  15. c-02-003-saleC.02.003 - sale
  16. c-02-004-premisesC.02.004 - premises
  17. c-02-005-equipmentC.02.005 - equipment
  18. c-02-006-personnelC.02.006 - personnel
  19. c-02-007-c-02-008-sanitationC.02.007 - c.02.008 - sanitation
  20. c-02-007-sanitationC.02.007 - sanitation
  21. c-02-008-sanitationC.02.008 - sanitation
  22. C.02.009 - c.02.010 - raw material testing
  23. C.02.009 - raw material testing
  24. C.02.010 - raw material testing
  25. C.02.011 - c.02.012 - manufacturing control
  26. C.02.011 - manufacturing control
  27. C.02.012 - manufacturing control
  28. C.02.013 - c.02.015 - quality control
  29. c-02-013-quality-controlC.02.013 - quality control
  30. C.02.013 - quality control department
  31. c-02-014-quality-controlC.02.014 - quality control
  32. C.02.014 - quality control department
  33. c-02-015-quality-controlC.02.015 - quality control
  34. C.02.015 - quality control department
  35. C.02.016 - c.02.017 - packaging material testing
  36. C.02.016 - packaging material testing
  37. C.02.017 - packaging material testing
  38. C.02.018 - c.02.019 - finished product testing
  39. C.02.018 - finished product testing
  40. C.02.019 - finished product testing
  41. c-02-020-c-02-024-recordsC.02.020 - c.02.024 - records
  42. c-02-020-recordsC.02.020 - records
  43. c-02-021-recordsC.02.021 - records
  44. c-02-022-recordsC.02.022 - records
  45. c-02-023-recordsC.02.023 - records
  46. c-02-024-recordsC.02.024 - records
  47. c-02-025-c-02-026-samplesC.02.025 - c.02.026 - samples
  48. c-02-025-samplesC.02.025 - samples
  49. c-02-026-samplesC.02.026 - samples
  50. c-02-027-c-02-028-stabilityC.02.027 - c.02.028 - stability
  51. c-02-027-stabilityC.02.027 - stability
  52. c-02-028-stabilityC.02.028 - stability
  53. c-02-029-sterile-productsC.02.029 - sterile products
  54. c-05-003-prohibitionC.05.003 - prohibition
  55. c-05-006-authorizationC.05.006 - authorization
  56. c-05-007-notificationC.05.007 - notification
  57. c-05-008-amendmentC.05.008 - amendment
  58. C.05.010 - sponsor's obligations - good clinical practices
  59. c-05-011-labellingC.05.011 - labelling
  60. c-05-012-recordsC.05.012 - records
  61. C.05.014 - serious unexpected adverse drug reaction reporting
  62. c-08-003-label-updateC.08.003 - label update
  63. c-08-007-new-drugsC.08.007 - new drugs
  64. C.08.008 (c) - unusual failure in efficacy
  65. c-08-008-efficacyC.08.008 - efficacy
  66. c-08-008-new-drugsC.08.008 - new drugs
  67. equipment-c-02-005Equipment - c.02.005
  68. fda-s-19-hazardous-devicesFDA s.19 - hazardous devices
  69. fda-s-20-1-misrepresentationFDA s.20 (1) - misrepresentation
  70. FDA s.20(1) - prohibition of misrepresentation
  71. FDA s.20(2) - labelling violations
  72. FDA s.21 - prescribed standards
  73. FDA s.3(1) - no schedule a claims in ads
  74. FDA s.3(2)(a) - schedule a label claims - no sale
  75. FDA s.3 (2)(b) - schedule a label claims - no sale
  76. FDA s.3 (3) no contraceptive ads to general public
  77. fda-s-37-exportsFDA s.37 - exports
  78. Io covid-19 s.10 - terms and conditions
  79. MDR s.10 - safety and effectiveness
  80. MDR s.14 - transport and storage
  81. mdr-s-21-1-a-name-of-deviceMDR s.21(1)(a) - name of device
  82. mdr-s-21-1-b-manufacturerMDR s.21(1)(b) - manufacturer
  83. MDR s.21(1)(c) - device identifier
  84. mdr-s-21-1-d-control-numberMDR s.21(1)(d) - control number
  85. mdr-s-21-1-e-contentsMDR s.21(1)(e) - contents
  86. mdr-s-21-1-g-expiry-dateMDR s.21(1)(g) - expiry date
  87. MDR s.21(1)(h) - medical conditions
  88. MDR s.21(1)(i) - directions for use
  89. MDR s.21(1)(j) - storage conditions
  90. MDR s.21 (1) labelling deficiencies
  91. MDR s.21(1) - labelling requirements
  92. MDR s.21 (1) multiple label deficiencies
  93. MDR s.21(1) - multiple labelling deficiencies
  94. mdr-s-21-1-no-labelMDR s.21 (1) no label
  95. mdr-s-21-2-legibilityMDR s.21(2) - legibility
  96. mdr-s-21-s-23-labellingMDR s.21 - s.23 - labelling
  97. MDR s.22(1) - placement for general public
  98. MDR s.23(1) - official languages
  99. MDR s.23(1) - sale to general public - bilingual requirements
  100. MDR s.23(2) - bilingual directions for use
  101. MDR s.23 (2) directions for use - bilingual option
  102. MDR s.23(3) - sale to general public - bilingual requirements
  103. MDR s.26, mdr 27 - sale or advertising of unauthorized devices
  104. MDR s.26 - no sale or import of unlicensed devices
  105. MDR s.26 - sale or advertising of unauthorized devices
  106. MDR s.27 (a) no advertising of unlicensed devices
  107. MDR s.27(a) - no advertising unlicensed devices
  108. MDR s.27(b) - catalogue advertising of devices
  109. MDR s.27 - no sale or import of unlicensed devices
  110. MDR s.27 - sale or advertising of unauthorized devices
  111. MDR s.44 (1) no sale or import without establishment licence
  112. MDR s.44(1) - sale or import without establishment licence
  113. MDR s.44(3) - import from company without establishment licence
  114. MDR s.44 - establishment licensing
  115. MDR s.45(a) - name and address of establishment
  116. MDR s.45(b) - name, title, phone number of el contact person
  117. mdr-s-45-c-activitiesMDR s.45(c) - activities
  118. MDR s.45 - distribution records
  119. MDR s.45(d) - names of manufacturers
  120. MDR s.45 - establishment licensing
  121. mdr-s-45-f-device-classesMDR s.45(f) - device classes
  122. MDR s.45(g) - distribution, complaints, recalls
  123. MDR s.45(g) - distribution records
  124. mdr-s-45-g-proceduresMDR s.45(g) - procedures
  125. MDR s.45(h.1) - incident reporting
  126. MDR s.45 (h.1) incident reporting and/or provision of information in respect of serious…
  127. MDR s.45(h.1) - provision of information related to risk
  128. MDR s.45(h.1) - provision of information related to serious risk of injury to human health
  129. MDR s.45 - handling, storage or delivery
  130. MDR s.45(h)-(h.1) - incident reporting
  131. MDR s.45(h) - incident reporting
  132. MDR s.45(h) - mandatory problem reporting
  133. MDR s.45(h) - mandatory problem reports
  134. mdr-s-45-h-proceduresMDR s.45(h) - procedures
  135. mdr-s-45-i-corrective-actionMDR s.45(i) - corrective action
  136. MDR s.45(i) - handling storage and delivery, etc.
  137. MDR s.45(i) - handling, storage, delivery, etc.
  138. mdr-s-45-incident-reportingMDR s.45 - incident reporting
  139. mdr-s-45-j-listed-sitesMDR s.45(j) - listed sites
  140. MDR s.45, mdr s.52 - mdr s.56 - distribution records
  141. mdr-s-45-problem-reportingMDR s.45 - problem reporting
  142. mdr-s-45-proceduresMDR s.45 - procedures
  143. MDR s.45 - provision of information related to serious risk of injury to human health
  144. MDR s.48 - establishment licence changes
  145. MDR s.48 - establishment licensing
  146. MDR s.48 notification with respect to change to 45(a),(b) in 15 days
  147. MDR s.52(1) - distribution records per device
  148. MDR s.52 - mdr s.56 - distribution records
  149. MDR s.53 - sufficient for product withdrawal
  150. MDR s.53 sufficient information for complete and rapid recall
  151. mdr-s-55-retention-timeMDR s.55 - retention time
  152. mdr-s-56-timely-availabilityMDR s.56 - timely availability
  153. MDR s.57(1)(a) - records of problems
  154. MDR s.57 (1)(a) records of problems, complaints
  155. MDR s.57(1)(b) - records of actions taken
  156. mdr-s-57-complaintsMDR s.57 - complaints
  157. mdr-s-58-a-complaintsMDR s.58(a) - complaints
  158. MDR s.58(a) - investigation procedure
  159. MDR s.58 b, mdr s.64 - recall reporting
  160. mdr-s-58-b-recall-procedureMDR s.58(b) - recall procedure
  161. mdr-s-58-b-recall-reportingMDR s.58(b) - recall reporting
  162. mdr-s-58-b-recallsMDR s.58(b) - recalls
  163. MDR s.59(1) - incident reporting
  164. MDR s.59(1) - mandatory problem reporting
  165. MDR s.59(1) - obligation to report
  166. MDR s.59(2) - mandatory problems outside canada
  167. MDR s.59-61.1 - incident reporting
  168. MDR s.59 - s.61 - problem reporting
  169. MDR s.59 - s61 - problem reporting
  170. MDR s.60(1)(a)(ii) - preliminary report - 30 days
  171. MDR s.60(1)(a)(i) - preliminary report - 10 days
  172. MDR s.60(1)(b) - time limits - outside canada
  173. MDR s.60(2)(a)-(i) - contents of preliminary report
  174. MDR s.60(2)(a)-(i) - incident reporting
  175. MDR s.61 (1) submission of final report with respect to 60(2)(h)
  176. MDR s.61(1) - submit final report with respect to 60(2)(h)
  177. MDR s.61.2(2) - provision of information on serious risk of injury to human health
  178. MDR s.61.2(2) - provision of information related to serious risk of injury to human health
  179. MDR s.61.2 (3) provision of information in respect of risk within 72 hours
  180. MDR s.61.2(3) - provision of information related to serious risk of injury to human health
  181. MDR s.61 (2)(b) incident report - cause and actions taken
  182. MDR s.61(2) - incident reporting
  183. MDR s.61(2) - mandatory problem reports
  184. MDR s.61.4 (1)(a) preparation of summary reports for class ii medical devices
  185. MDR s.61.4 (1)(b) preparation of summary reports for class iii or iv medical devices
  186. mdr-s-61-4-1-summary-reportsMDR s.61.4(1) - summary reports
  187. mdr-s-61-4-2-summary-reportsMDR s.61.4(2) - summary reports
  188. MDR s.61.4-s.61.6 - summary reports
  189. MDR s.63.2 (a)-(g) contents of recall notification
  190. MDR s.63.2 recall notification within 24 hours
  191. MDR s.64 (a) - (k) - contents of initial recall report
  192. MDR s.64 (a)-(n) contents of initial recall report
  193. mdr-s-64-recall-reportingMDR s.64 - recall reporting
  194. MDR s.64 - submit initial recall report
  195. MDR s.64 timeline requirement for initial recall report
  196. mdr-s-64-unreported-recallMDR s.64 unreported recall
  197. MDR s.65.4 recall records for distributor
  198. MDR s.65(a),(b) - contents of final recall report
  199. mdr-s-65-recall-reportingMDR s.65 - recall reporting
  200. MDR s.65 - submit final recall report
  201. MDR s.65 timeline requirement for final recall report
  202. MDR s.70 - no sale/import without authorization
  203. MDR s.75(a)-(c) - specific labelling
  204. MDR s.75 - custom-made devices and special access
  205. MDR s.76 - distribution records
  206. MDR s.76 distribution records per device
  207. MDR s.80(2) - authorization and records
  208. MDR s.87(b) - investigational device - advertising
  209. MDR s.89(1) - export certificates
  210. mdr-s-91-export-certificatesMDR s.91 - export certificates
  211. MDR s.9(1) - safety and effectiveness - obligations
  212. MDR s.9 (2) safety and effectiveness - evidence
  213. Quality control department - c.02.015
  214. S.3(2)(a) - schedule a label claims - no sale
  215. section-100-equipmentSection 100 - equipment
  216. Section 100 - personnel, facilities, equipment and supplies
  217. section-101-equipmentSection 101 - equipment
  218. Section 101 - personnel, facilities, equipment and supplies
  219. Section 102 - personnel, facilities, equipment and supplies
  220. section-102-suppliesSection 102 - supplies
  221. Section 103 - errors and accidents
  222. Section 104 - errors and accidents
  223. Section 107 - investigation and reporting
  224. Section 108 - investigation and reporting
  225. Section 110 - adverse recipient reactions
  226. Section 112 - investigation and reporting of adverse recipient reactions
  227. Section 113 - investigation and reporting of adverse recipient reactions
  228. Section 114 - investigation and reporting of adverse recipient reactions
  229. section-117-recordsSection 117 - records
  230. section-118-recordsSection 118 - records
  231. section-119-recordsSection 119 - records
  232. section-121-recordsSection 121 - records
  233. section-122-recordsSection 122 - records
  234. Section 23 - establishment licences
  235. section-31-registrationSection 31 - registration
  236. section-33-registrationSection 33 - registration
  237. section-38-58-processingSection 38-58 - processing
  238. Section 39 - donor suitability assessment
  239. Section 41 - donor suitability assessment
  240. Section 42 - donor suitability assessment
  241. Section 44 - donor suitability assessment
  242. section-45-collectionSection 45 - collection
  243. section-48-collectionSection 48 - collection
  244. section-49-collectionSection 49 - collection
  245. section-51-collectionSection 51 - collection
  246. section-52-testingSection 52 - testing
  247. Section 5-37 - authorizations, establishment licenses and registrations
  248. section-59-68-labellingSection 59-68 - labelling
  249. section-61-labellingSection 61 - labelling
  250. section-64-labellingSection 64 - labelling
  251. section-65-labellingSection 65 - labelling
  252. section-68-labellingSection 68 - labelling
  253. section-69-72-storageSection 69-72 - storage
  254. section-69-storageSection 69 - storage
  255. section-70-storageSection 70 - storage
  256. section-73-76-distributionSection 73-76 - distribution
  257. section-75-distributionSection 75 - distribution
  258. section-76-distributionSection 76 - distribution
  259. section-77-80-transformationSection 77-80 - transformation
  260. section-77-transformationSection 77 - transformation
  261. section-78-transformationSection 78 - transformation
  262. section-79-transformationSection 79 - transformation
  263. section-80-transformationSection 80 - transformation
  264. Section 93-123 - quality management
  265. Section 93 - quality management system
  266. Section 94 - quality management system
  267. Section 95 - operating procedures
  268. Section 96 - operating procedures
  269. Section 97 - operating procedures
  270. section-98-personnelSection 98 - personnel
  271. Section 98 - personnel, facilities, equipment and supplies
  272. section-99-facilitiesSection 99 - facilities
  273. Section 99 - personnel, facilities, equipment and supplies

About this dataset

Health Canada inspection reports cite the section of the Food and Drug Regulations, Medical Devices Regulations or Blood Regulations behind each observation. This page counts the published inspections that cite the requirement.

Source: Health Canada, Drug and Health Product Inspections; citation counts by Orca1. Contains information licensed under the Open Government Licence – Canada