№ lp_1_06639
File format: docx
Character count: 4150
File size: 95 KB
Year:
2026
Region / City:
Global
Topic:
Regulatory Compliance, Certification
Document Type:
Notification Form
Organization / Institution:
SGS
Author:
SGS
Target Audience:
Clients holding SGS certification
Period of Validity:
Ongoing
Approval Date:
N/A
Date of Changes:
N/A
Contextual Description:
A form for notifying SGS of any changes or regulatory actions affecting the validity or scope of certification for medical devices.
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Note:
Year
Document Type:
Audit Form
Audit Criteria:
ISO 13485:2016 and applicable national regulations
Scope of Audit Program:
Design and development, Manufacturing, Distribution, Installation, Servicing
Year:
2021
Region / City:
International
Topic:
Medical Device Regulation, Auditing
Document Type:
Final Document
Organization / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF MDSAP Working Group
Target Audience:
Regulatory Authorities, Auditing Organizations
Effective Period:
Not specified
Approval Date:
16 September 2021
Revision Date:
Not specified
Year:
2016
Region / City:
International
Theme:
Medical Device Auditing, Certification
Document Type:
Application Form
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Regulatory Authorities, Auditing Organizations
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Note:
Year
Topic:
Wastewater Regulation
Document Type:
Form
Year:
2021
Region / City:
West and Central Africa
Topic:
Electricity, Governance, Institutional Strengthening, Africa
Document Type:
Report
Organization:
European Union, African Union Commission
Author:
Dr. Dimitris Papastefanakis, Dr. William Gboney, Dr. George Kyriakarakos, Mr. Jian Bani
Target Audience:
Policy makers, energy sector professionals
Period of Validity:
2021-2040
Approval Date:
August 31, 2021
Date of Revisions:
N/A
Note:
Year
Year:
2014
Region / City:
Global
Topic:
Pharmaceutical Product Prequalification
Document Type:
Guideline
Organization / Institution:
World Health Organization (WHO)
Author:
World Health Organization
Target Audience:
Pharmaceutical manufacturers, regulatory bodies
Effective Period:
Not specified
Approval Date:
2014
Modification Date:
Not specified
Note:
Year
Topic:
Pharmaceutical product, regulatory approval, prequalification
Document type:
Template
Organization / institution:
WHO
Target audience:
Regulatory authorities, pharmaceutical manufacturers
Year:
2023
Region / City:
United States
Subject:
Pharmaceutical Regulatory Guidance
Document Type:
Guidance
Organization / Institution:
FDA
Author:
FDA
Target Audience:
Industry stakeholders, Sponsors, Applicants
Effective Period:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Note:
Contextual Description
Year:
2023
Region / City:
Global
Topic:
Biopharmaceutical studies, bioavailability, bioequivalence
Document Type:
Regulatory Guidance
Agency / Institution:
FDA, EMA
Author:
Not specified
Target Audience:
Industry professionals in pharmaceuticals
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified
Note:
Year
Year:
2026
Region / City:
Global
Topic:
Clinical Efficacy Studies
Document Type:
Guidance
Author:
FDA
Target Audience:
Industry professionals in pharmaceuticals
Action Period:
Ongoing
Approval Date:
N/A
Modification Date:
N/A
Description:
Regulatory guidance on the structure and numbering of templates in eCTD submissions, with a focus on the proper organization and presentation of efficacy studies in pharmaceutical documentation.
Year:
2023
Region / City:
Sellafield
Theme:
Nuclear Waste Management, Environmental Safety, Nuclear Regulatory Oversight
Document Type:
Regulatory Position Report
Organization / Institution:
Office for Nuclear Regulation (ONR)
Author:
Office for Nuclear Regulation (ONR)
Target Audience:
Stakeholders in nuclear safety, regulatory bodies, Sellafield Limited
Period of Validity:
Until MSSS waste retrieval completion (2045-2050)
Approval Date:
2023
Date of Amendments:
None
Year:
2021
Region / city:
Worldwide
Topic:
Biotherapeutic Product Documentation
Document type:
Guidelines
Organization / institution:
World Health Organization (WHO)
Author:
World Health Organization (WHO)
Target audience:
Regulatory authorities, pharmaceutical companies, healthcare professionals
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2017
Region / city:
Wisconsin, Madison
Subject:
Radiation safety policy for dental facilities
Document type:
Regulatory guide
Institution / organization:
Department of Health Services, Division of Public Health, Radiation Protection Section
Author:
Wisconsin Department of Health Services
Target audience:
Dental facilities and operators
Period of validity:
Ongoing
Approval date:
April 2017
Date of changes:
N/A
Year:
2005
Region / City:
England & Wales
Subject:
Fire Safety, Risk Assessment
Document Type:
Template
Organization / Institution:
C.S. Todd & Associates Ltd.
Author:
Colin Todd, MBE
Target Audience:
Persons responsible for fire safety, safety assessors
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Modifications:
Not specified
Year:
2022
Region / City:
Scotland
Topic:
Sewage discharge regulations
Document type:
Regulatory method
Organization / Institution:
Scottish Environment Protection Agency (SEPA)
Author:
Scottish Environment Protection Agency (SEPA)
Target Audience:
Environmental professionals, sewage management stakeholders
Effective period:
Ongoing
Approval date:
April 2022
Amendment date:
V9.0 updates in 2022
Year:
2023
Region / City:
[insert name of school district]
Theme:
Health and Safety
Document Type:
Letter
Organization / Institution:
[insert name of school district]
Author:
[insert name of school district]
Target Audience:
Parents, Guardians, Medical Providers
Period of Validity:
Ongoing
Approval Date:
[insert date]
Modification Date:
[insert date]
Note:
Year
Region / City:
Bernalillo County
Theme:
Air Quality, Environmental Regulations
Document Type:
Application Form
Agency / Institution:
City of Albuquerque
Target Audience:
Facility owners, operators, and applicants for AQN
Certification:
Signed by responsible officer