№ lp_2_1_23504
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This document provides guidance on post-market surveillance procedures for medical devices, including criteria and forms for the exchange of National Competent Authority Reports (NCAR) among regulatory bodies.
Year:
2015
Region / city:
International
Topic:
Medical Device Regulation
Document Type:
Official Report
Organization / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
National Competent Authority Report Working Group
Target Audience:
Medical Device Regulators, Public Health Authorities
Period of validity:
Ongoing
Approval Date:
26 March 2015
Date of amendments:
None
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
XXXX
Region / city:
XXXX
Topic:
Medical Device Safety and Performance Evaluation
Document Type:
Evaluation Report
Organization / Institution:
XXXX
Author:
XXXX
Target Audience:
Regulatory Bodies, Medical Device Manufacturers
Period of Effectiveness:
XXXX
Approval Date:
XXXX
Date of Changes:
XXXX
Year:
YYYY
Region / City:
[City/Region]
Topic:
Medical Device Safety and Performance Monitoring
Document Type:
PMCF Plan
Organization:
[Manufacturer Name]
Author:
[Author Name]
Target Audience:
Regulatory Authorities, Medical Device Manufacturers
Validity Period:
YYYY/MM/DD to YYYY/MM/DD
Approval Date:
DD/MM/YYYY
Revision Date:
XXXX
Date of Changes:
YYYY/MM/DD
Year:
2016-2017
Region / city:
Australia
Topic:
Life Saving Drugs Program, Rare Diseases, Health Policy
Document type:
Government Report
Organization / institution:
Australian Government
Author:
Australian Government
Target audience:
Health policymakers, healthcare professionals, stakeholders in rare disease treatment
Period of validity:
Ongoing
Date of approval:
2014-04-09
Date of amendments:
None
Year:
2023
Region / City:
Australia
Subject:
Smoking cessation, pharmaceutical benefits
Document Type:
Report
Institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Unknown
Target Audience:
Healthcare providers, policymakers
Period of Effect:
Ongoing
Approval Date:
Unknown
Date of Changes:
Unknown
Year:
2021
Region / City:
Australia
Topic:
Smoking cessation, medicines cost-effectiveness, Pharmaceutical Benefits Scheme
Document type:
Report
Organization:
Pharmaceutical Benefits Advisory Committee
Author:
Centre for Health Economics, Monash University
Target audience:
Health professionals, policy makers, Pharmaceutical Benefits Advisory Committee members
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Purpose:
Post-market review, cost-effectiveness evaluation
Clinical issue:
Smoking cessation treatment
Proposed changes to PBS restrictions:
Yes
Market size:
Pharmacological assisted quit attempts
Treatment costs and co-payments:
Yes
Market growth:
Change in quit attempts
Health outcomes:
Quit rates, relapse rates, smoking-related diseases
References:
Yes
Note:
Contextual description
Year:
2023
Region / City:
Australia
Topic:
Opioid Dependence Treatment, Pharmaceutical Benefits Scheme
Document Type:
Government Report
Organization:
Australian Government Department of Health and Aged Care
Author:
Australian Government Department of Health and Aged Care
Target Audience:
Stakeholders, policymakers, healthcare providers, public
Effective Period:
2023-07-01 and onwards
Approval Date:
2023-03-01
Modification Date:
N/A
Interim Review Outcomes Date:
2023-03-01
Note:
Contextual Description
Year:
2019
Region / Country:
Australia
Subject:
Pulmonary arterial hypertension medicines and subsidy policy
Document Type:
Policy review agenda item and briefing
Institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Program:
Pharmaceutical Benefits Scheme (PBS)
Topic:
Post-Market Review (PMR) of PAH medicines
Medicines Mentioned:
bosentan, ambrisentan, macitentan, sildenafil, tadalafil, iloprost, riociguat, epoprostenol
Medical Classification Referenced:
WHO Functional Class II–IV pulmonary arterial hypertension
Guidelines Referenced:
2015 European Society of Cardiology / European Respiratory Society Guidelines for the diagnosis and treatment of pulmonary hypertension
Stakeholders:
PAH Reference Group, medicine sponsors including Actelion, GlaxoSmithKline, and Pfizer
Regulatory Focus:
Revision of PBS prescribing restrictions and subsidy conditions
Key Policy Changes Considered:
Extension of subsidised monotherapy to WHO Functional Class II patients, updated PAH definition, inclusion of additional WHO Group 1 PAH subtypes, removal of calcium channel blocker trial requirement, strengthened diagnostic role of right heart catheterisation
Consultation Process:
Pre-PBAC consultation with sponsors and reference group
Associated Meetings:
PBAC meetings in November 2018, March 2019, and planned July 2019 review discussion
Related Policy Activity:
Planned stakeholder meeting on PAH combination therapy scheduled for May 2019
Year:
2023
Region / City:
European Union
Subject:
Biocidal Products Regulation (EU) No 528/2012
Document Type:
Report
Organization / Institution:
European Chemicals Agency (ECHA)
Author:
European Chemicals Agency (ECHA)
Period of Validity:
Ongoing, with updates from 2015 to 2023
Approval Date:
December 2023
Date of Last Changes:
December 2023
Year:
2011
Region / City:
London
Topic:
Railways, Interoperability, Safety Regulations
Document Type:
Application Letter
Organization:
Department for Transport
Author:
PROJECT ENTITY
Target Audience:
Competent Authority, Rail Interoperability Team
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
2024
Region / city:
Not specified
Topic:
Biocidal products
Document type:
Meeting minutes
Institution:
European Commission
Author:
Not specified
Target audience:
Competent Authorities of EU Member States
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Context:
Meeting minutes of the 106th session of the Competent Authorities for the implementation of Regulation (EU) No 528/2012, discussing issues related to biocidal products and their regulation within the EU.
Year:
2024
Region / City:
European Union
Topic:
Biocidal Products, Legislation
Document Type:
Meeting Minutes
Organization / Institution:
European Commission
Author:
European Commission
Target Audience:
Competent Authorities of Member States
Period of validity:
26-27 September 2024
Approval Date:
27 September 2024
Date of amendments:
None
Contextual Description:
Minutes of a meeting of the representatives of Competent Authorities from Member States, discussing the implementation of Regulation (EU) No 528/2012 concerning biocidal products.
Year:
2015
Region / city:
European Union
Subject:
Management of product authorisation for in situ cases
Type of document:
Official guideline
Organization:
European Commission
Target audience:
Competent Authorities, applicants for biocidal product authorisation
Effective period:
Ongoing
Approval date:
23 June 2015
Year:
2023
Region / city:
Brussels
Subject:
Chemicals, Classification, and Labelling
Document Type:
Meeting Record
Organ / institution:
European Commission
Author:
Directorate-General for Environment, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
Target audience:
Competent Authorities for REACH and CLP
Period of validity:
06/03/2024
Approval date:
06/03/2024
Date of changes:
N/A
Contextual description:
A record of the 50th meeting of the Competent Authorities for REACH and CLP, discussing updates on the Globally Harmonized System, ongoing work on new hazard classes, and the implementation of GHS revisions.
Year:
2023
Region / City:
European Union
Subject:
Biocidal products, Regulation (EU) No 528/2012, Union authorisation
Document Type:
Official Discussion Paper
Authoring Organization:
European Commission
Period of Validity:
Ongoing
Date of Approval:
N/A
Date of Last Revision:
N/A
Year:
2022
Region / City:
Europe
Topic:
Biocidal products
Document Type:
Agenda
Organization / Institution:
Competent Authorities for the implementation of Regulation (EU) No 528/2012
Author:
N/A
Target Audience:
Member States Competent Authorities
Period of Validity:
22-23 June 2022
Approval Date:
N/A
Date of Modifications:
N/A
Date:
28/04/2022
Region / City:
Brussels
Subject:
Polymers, Chemicals Strategy
Document Type:
Background Document
Organization:
European Commission, Directorate-General for Environment
Author:
European Commission
Target Audience:
REACH and CLP Competent Authorities, Environmental Experts
Period of Application:
May 2022
Approval Date:
28/04/2022
Year:
2017
Region / city:
European Union
Subject:
Implementing the concept of biocidal product family
Document type:
Guidance note
Author:
European Commission
Period of validity:
Ongoing
Approval date:
November 2014
Date of changes:
March 2017, July 2017
Keywords:
Biocidal product family, authorisation, regulation, EU, risk assessment, efficacy
Year:
1993
Region / City:
South Africa
Topic:
Occupational Health and Safety
Document Type:
Appointment Letter
Institution:
Employer
Author:
CEO
Target Audience:
Employee
Period of Validity:
Ongoing
Approval Date:
Not specified
Modification Date:
Not specified