№ lp_2_3_39200
File format: docx
Character count: 17573
File size: 95 KB
Regulatory guidance document outlining harmonized technical and structural specifications for assembling IMDRF Table of Contents–based medical device premarket submissions within participating jurisdictions.
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
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
Note:
Year
Year:
2025
Region / City:
Chicago, IL
Theme:
Healthcare, Medical Equipment
Document Type:
Resource Guide
Institution:
CountyCare
Author:
N/A
Target Audience:
Healthcare Providers, CountyCare Teams
Effective Period:
May 2025
Approval Date:
N/A
Revision Date:
N/A
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 Type:
Technical Specification
Product Name:
Hach BioTector B3500ul Online TOC Analyzer
Manufacturer:
Hach Ireland Ltd
Measurement Parameters:
Total Organic Carbon (TOC), Total Carbon (TC), Total Inorganic Carbon (TIC), Biological Oxygen Demand (via correlation), Chemical Oxygen Demand (via correlation), Volatile Organic Carbon (via calculation)
Measurement Method:
Two Stage Advanced Oxidation utilizing hydroxyl radicals and manganese catalyst
Measurement Range:
0 – 5 mgC/l
Detection Limit:
0.010 mgC/l
Repeatability:
±2% of reading or ±0.01 mgC/l
Cycle Time:
From 5 minutes depending on range and application
Sample Requirements:
Minimum 100 ml per analysis; ambient pressure; 2 to 60 °C
Operating Conditions:
0 to 45 °C; 5 to 85% relative humidity non-condensing
Certifications:
CE, KC, ACMA, China RoHS
Warranty Period:
One year from date of shipment
Installation Requirements:
Installation per transmittal drawings and user manual; manufacturer start-up and service required
Service Conditions:
Factory-trained personnel only; manufacturer parts and reagents required
Data Transmission:
SD card
Year:
2022
Version:
4
Place of publication:
Geneva
Organization:
World Health Organization
Department:
WHO Prequalification of In Vitro Diagnostics
Document code:
WHO/MHP/RPQ/PQT/2022.03
Licence:
Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO (CC BY-NC-SA 3.0 IGO)
Subject:
Prequalification of in vitro diagnostics
Document type:
Product dossier checklist
Intended users:
IVD manufacturers submitting dossiers for WHO prequalification
Related document:
IMDRF/RPS WG/N13 FINAL:2019 (Edition 3)
Language requirement:
English
Format requirement:
Searchable PDF
Administrative reference:
PQDx_015 Pre-Submission Form
International guideline referenced:
International Medical Device Regulators Forum
Year:
2012
Region / city:
United States
Topic:
Speech Codes on University Campuses
Document Type:
Article
Author:
Greg Lukianoff
Target Audience:
Students, Educators, Policy Makers
Period of Action:
Ongoing
Approval Date:
December 19, 2012
Date of Changes:
None
Note:
Contextual Description
Year:
[Year]
Region / City:
[NAME OF JURISDICTION]
Topic:
Transit-Oriented Communities Compliance
Document Type:
Resolution
Institution:
Metropolitan Transportation Commission (MTC)
Author:
[MAYOR OR CITY MANAGER]
Target Audience:
Metropolitan Transportation Commission (MTC), Local Jurisdictions
Action Period:
2026
Approval Date:
[Approval Date]
Amendment Date:
[Amendment Date]
Year:
2016
Region / City:
Brazil
Topic:
Soil analysis
Document Type:
Research report
Institution:
Gomes
Author:
Gomes
Target audience:
Researchers, Soil Scientists
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
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
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
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