Guidance document : requirements in the recognition process for Medical Device Single Audit Program (MDSAP) auditing organizations.: H13-9/30-2018E-PDF
"The purpose of this document is to outline the requirements that the Therapeutic Products Directorate (TPD) will use in the recognition process for Auditing Organizations. This policy applies to the quality management system (QMS) certification requirements applicable to Class II, III and IV medical devices in the Medical Devices Regulations. For the purposes of this policy, the term ‘Auditing Organization’ has the same meaning as the term ‘registrar’ found in the Medical Devices Regulations"--Introduction, page 5.
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| Department/Agency | Canada. Health Canada. |
|---|---|
| Title | Guidance document : requirements in the recognition process for Medical Device Single Audit Program (MDSAP) auditing organizations. |
| Variant title | Requirements in the recognition process for Medical Device Single Audit Program (MDSAP) auditing organizations Requirements in the recognition process for MDSAP auditing organizations |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| Electronic document | |
| Note(s) | Title from cover. "Date adopted 2018-10-30 ; Effective date 2019-01-01." Issued also in HTML format. Issued also in French under title: Ligne directrice : exigences du processus de reconnaissance pour les organismes d’audit du Programme d’Audit Unique pour le Matériel Médical (PAUMM). Includes bibliographical references. |
| Publishing information | Ottawa, ON : Health Canada, 2018. ©2018 |
| Description | 1 online resource (11 pages) : chart |
| ISBN | 9780660283920 |
| Catalogue number |
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| Departmental catalogue number | Pub.: 180554 |
| Subject terms | Medical products Audit Program development |
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