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This document outlines the standard operating procedures followed by the International Medical Device Regulators Forum (IMDRF) in developing and managing documents and memberships related to medical device regulation.
Year:
2021
Region / City:
International
Topic:
Medical Device Regulation
Document Type:
Standard Operating Procedures
Organization:
International Medical Device Regulators Forum
Author:
IMDRF Management Committee
Target Audience:
Regulatory Authorities, Medical Device Regulators
Effective Period:
Ongoing
Approval Date:
25 March 2021
Modification Date:
Not specified
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Year:
2019
Region / City:
International
Subject:
Medical device adverse event reporting
Document Type:
Proposed document
Organ / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF Adverse Event Terminology Working Group
Intended Audience:
Regulatory authorities, healthcare providers, manufacturers, reporters of adverse events
Period of validity:
Not specified
Approval date:
27th June 2019
Date of Changes:
Not specified
Year:
2020
Region / City:
International
Topic:
Medical device regulation
Document Type:
Final Document
Organization / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF Adverse Event Terminology Working Group
Intended Audience:
Regulatory authorities, medical device manufacturers, healthcare providers
Period of Validity:
Not specified
Approval Date:
18 March 2020
Date of Changes:
Not specified
Year:
2025
Organization:
International Medical Device Regulators Forum (IMDRF)
Type:
Implementation Report
Authors:
IMDRF Management Committee, Authoring Group
Scope:
International medical device regulatory convergence
Document Series:
IMDRF/MC/N84
Related Documents:
IMDRF technical documents, GHTF documents
Implementation Status Categories:
Implemented, Partly Implemented, Not Implemented, Not Applicable
Countries Covered:
Brazil, Canada, China, EU, Japan, Russia, Singapore, Switzerland, USA, Argentina, Saudi Arabia, Australia, South Korea, UK
Audience:
Regulatory authorities and stakeholders in medical device regulation
Year:
2018
Region / city:
International
Topic:
Medical device regulation
Document type:
Proposed document
Organization / institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF UDI WG
Target audience:
Medical device regulators
Period of validity:
Ongoing
Approval date:
12 July 2018
Date of changes:
None
Year:
2014
Region / City:
International
Topic:
Medical Device Submissions
Document Type:
Guidance Document
Organization / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF RPS ToC Working Group
Target Audience:
Medical device industry, regulatory authorities
Implementation Period:
Pre-RPS electronic submission environment
Approval Date:
30 June 2014
Amendment Date:
Not specified
Year:
2015
Region / city:
International
Theme:
Medical device regulation, pilot program
Document type:
Final document
Organization / institution:
International Medical Device Regulators Forum (IMDRF)
Author:
Toshiyoshi Tominaga, IMDRF Chair
Target audience:
Medical device regulators, industry participants
Period of validity:
2015-2016
Date of approval:
8 July 2015
Date of revisions:
N/A
Document Number:
IMDRF/RPS WG (PD1)/N27R2
Status:
Proposed Document
Organization:
International Medical Device Regulators Forum
Authoring Group:
Regulated Product Submissions Table of Contents Working Group
Date:
17 September 2015
Subject:
Medical device regulatory submissions
Scope:
Assembly of IMDRF Table of Contents (ToC) based submissions
Related Standard:
Health Level Seven (HL7) Regulated Product Submission Standard
Related Documents:
IMDRF In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC); IMDRF Non-In Vitro Diagnostic Medical Device Market Authorization Table of Contents (nIVD MA ToC); IMDRF Standard ToC Folder Structure; IMDRF Frequently Asked Questions Document
Submission Types:
Non-IVD Market Authorization; IVD Market Authorization
Participating Regions:
ANVISA; EU; Health Canada; TGA; USFDA; CFDA
Language:
English
Access:
No restrictions on reproduction, distribution or use
Year:
2019
Location:
New Delhi, India
Type of document:
Technical Proposal
Organization:
ITU-T Focus Group on AI for Health, WG-DAISAM
Authors:
Luis Oala, Pradeep Balachandran, Pat Baird, Thomas Wiegand
Target audience:
Regulators, AI for health developers, medical device manufacturers
Period:
2017-2020
Document status:
Draft
Contact emails:
[email protected]; [email protected]; [email protected]; [email protected]
Abstract:
Provides a mapping of IMDRF Essential Principles to aspects of AI for health software
Keywords:
AI4H, IMDRF, SaMD, Regulatory framework, Risk management, Performance evaluation
Year:
2020
Region / Organization:
IMDRF
Subject:
Medical Device Adverse Event Terminology
Document Type:
Coding Guide / Terminology Reference
Annexes Covered:
A, B, C, D, E, F, G
Authoring Group:
IMDRF AE Working Group
Audience:
Medical device regulators, terminology specialists
Hierarchy Details:
Terms in Annex A, C, D, F, G occur once; Annex B has no hierarchy; Annex E terms may appear at multiple levels
Columns Included:
Level 1 Term, Level 2 Term, Level 3 Term, Code, CodeHierarchy, Definition, Non-IMDRF Code/Term, Status, Status Description, Primary Category, Secondary Category (E only)
Purpose:
Standardizing term definitions and hierarchical coding for adverse events in medical devices
Year:
2023
Region / City:
N/A
Topic:
Registration Service, Operational Choreography
Document Type:
Change Request
Organization:
MHHS Programme
Author:
N/A
Target Audience:
Programme Participants
Period of Validity:
N/A
Approval Date:
08/02/2023
Date of Changes:
N/A
Organization:
United Nations Development Programme
Country:
Kuwait
Document type:
Standard Operating Procedures
Subject area:
Project cycle management
Implementation modality:
National Implementation Modality with Country Office support
Strategic framework:
UNDP Strategic Plan 2014–2017
Programme framework:
Country Programme Document and Country Programme Action Plan 2015–2018
Responsible institution:
UNDP Kuwait Country Office
Government coordinating agency:
General Secretariat of the Supreme Council for Planning and Development
Scope:
UNDP programmes and projects implemented in Kuwait
Project phases covered:
Formulation, appraisal, implementation, monitoring, evaluation, extension and closure
Intended users:
UNDP staff and national implementing partners
Annexes included:
Capacity assessment checklist, project document template, risk logs template, quality assurance checklist
Year:
Contract Year No.
Supplier:
Legal Name of Supplier
Facility:
Name of Facility
Contract:
Contract Title / Contract ID
Contract Date:
Contract Date
Time Period:
From insert date To insert date
Contract Capacity (MW):
Contract Capacity
Planned Outages:
As specified per unit and month
Unplanned Outages:
Percentage per unit and month
Overall Availability:
Percentage per unit and month
Type of Document:
Prescribed Form – Annual Operating Plan
Audience:
Buyer and Contract Management
Source:
Independent submission under Section 14.3(b)(i) of the Contract
Note:
Year
Issuing authority:
Ministry for Primary Industries
Jurisdiction:
New Zealand
Legal basis:
Biosecurity Act 1993
Document type:
Operating manual
Facility type:
Transitional Facility for uncleared risk goods
Approval status:
Approved Transitional Facility
Regulatory standards referenced:
TFGEN (Standard for General Transitional Facilities for Uncleared Risk Goods)
Scope of activities:
Receipt, holding, processing, treatment and inspection of uncleared risk goods; inspection of imported containers
Responsible roles:
Transitional Facility Operator; Deputy Transitional Facility Operator; Accredited Person
Compliance requirements:
MPI inspection and verification audits; access for MPI Inspectors at any reasonable time
Version control:
Review and amendments record with dates and sections
Training requirements:
MPI-approved training and refresher training for operators and accredited persons
Operational areas covered:
Security, biosecurity equipment, inspections, record keeping, hygiene management, pest control, audits, contingency plans
Organization:
AMJ Construction
Topic:
Covid-19 health and safety measures
Document type:
Company policy
Industry:
Construction
Applicable guidelines:
Construction Leadership Council; Public Health England
Target audience:
Employees, site visitors, clients, supply chain partners
Date referenced:
11 May 2020
Scope:
Construction sites operated by AMJ Construction
Review frequency:
Weekly
Key measures:
Site inductions, risk assessments, cleaning regimes, social distancing, PPE, signage, adjusted working hours
Year:
2015
Region / City:
United Kingdom
Topic:
Tender Process, Procurement
Document Type:
Invitation to Tender
Authority:
Department of Health
Target Audience:
Potential Tenderers
Validity Period:
From 16/11/2015 to 27/11/2015
Approval Date:
16/11/2015
Amendment Date:
Not specified
Year:
2023
Region / City:
South Africa
Theme:
Food Business Operations, Agriculture
Document Type:
Standard Operating Procedure
Organization:
Department of Agriculture, Forestry and Fisheries (DAFF)
Author:
Not specified
Target Audience:
Food business operators, DAFF personnel, relevant stakeholders
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Amendments:
Not specified
Year:
2025
Region / City:
Bloemfontein
Subject:
Procurement
Document Type:
Request for Bid (RFB)
Organization / Institution:
SITA
Author:
N/A
Target Audience:
Potential Bidders
Validity Period:
200 Days from the Closing Date
Approval Date:
N/A
Amendment Date:
N/A
Year:
2021
Region / City:
Air Force and Space Force Bases Worldwide
Subject:
CGOC Setup and Management
Document Type:
Guide
Organ / Institution:
Air Force National Company Grade Officers Council
Author:
Unknown
Target Audience:
Company grade officers, CGOC leaders
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Note:
Contextual Description
Year:
2026
Organization:
Department of the Air Force (DAF)
Type of document:
Training manual / Operational guide
Authors:
1st Lt Brianna Johndrow, Capt Hannah Kolobow
Target audience:
Company Grade Officers (CGOs)
Course duration:
Three days
Frequency:
Biannual or quarterly, depending on officer accession numbers
Contents:
FTOC startup procedures, recommended course structure, program documents
Access:
DAFCGOC TEAMS channel link provided
Communication:
Email contact for authors included
Professional focus:
Leadership development, integration into first assignment, technical and practical skills