ZL203_00_002e_WL Guidance document No marketing / interruption of distribution From Swiss Agency for Therapeutic Products (Swissmedic) π¨π This document provides guidance on the marketing and distribution of ZL203_00_002e_WL without any interruptions. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
International Recognition Procedure From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ How to use the procedure for medicines licensing applications. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated 3 weeks ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Pre-submission Advice & Support From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 13, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
List of persons responsible for custom-made medical devices marketing From National Agency for the Safety of Medicines and Health Products (ANSM) π«π· Reference document List of persons responsible for custom-made medical devices marketing in your application process Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 5, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 822 Postmarket Surveillance From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 822 Postmarket Surveillance". Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated on June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 879 of 28/05/2024 From Brazilian Health Regulatory Agency (Anvisa) π§π· Prohibits the manufacture, import and marketing, as well as the use in health services, of mercury and powder for non-encapsulated amalgam alloys indicated for use in dentistry. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 3, 2024 Other (Public Domain) 0 reuses 0 favorites
Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device From Food and Drug Administration (FDA) πΊπΈ Document number 2024-10895. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying the ultrasound cyclodestructive device, a postamendments class III device (product code LZR), into class II (special controls), subject to premarket notification. FDA isβ¦ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 20, 2024 Other (Public Domain) 0 reuses 0 favorites
Send and receive information on adverse drug reactions (ADRs) From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 9, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
GeGant From European Medicines Agency (EMA) πͺπΊ Information about marketing authorisation application of GeGant, a device to obtain a solution containing radioactive gallium. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 26, 2024 Other (Public Domain) 0 reuses 0 favorites
GN-15-R11 Guidance on Medical Device Product Registration (2024 Mar) PUB From Health Sciences Authority (HSA) πΈπ¬ Provides guidelines on product registration for medical devices. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on March 1, 2024 Other (Public Domain) 0 reuses 0 favorites
Operational Information Sharing From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ Guidance for Marketing Authorisation (MA) applicants on providing consent to share operational information during the MA application process. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 2, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
ZL404_00_001e_WL Guidance documentTransfer of marketing authorisation From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Guidance document on transferring marketing authorisation. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on May 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
How to draft a direct healthcare professional communication From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ Guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs) Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 4, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Questions and Answers (Q&A) on Points to Consider for Ensuring the Reliability in Utilization of Data from Registry or Medical Information Database in Applications for Marketing Approval and Re-examination for Regenerative Medical Products From Pharmaceuticals and Medical Devices Agency (PMDA) π―π΅ PSEHB/MDED Administrative Notice Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on March 31, 2023 Other (Public Domain) 0 reuses 0 favorites
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a draft guidance for the FDA and industry staff on marketing submission recommendations for AI/ML-enabled device software functions. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 30, 2023 Other (Public Domain) 0 reuses 0 favorites
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers : Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This is a guidance document titled "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" for premarket review by the FDA. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 21, 2023 Other (Public Domain) 0 reuses 0 favorites
Content of Human Factors Information in Medical Device Marketing Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a draft guidance for the FDA staff and industry on the content of human factors information in medical device marketing submissions. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 8, 2022 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Human Immunodeficiency Virus Viral Load Monitoring Tests From Food and Drug Administration (FDA) πΊπΈ Document number 2022-23868. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order to reclassify human immunodeficiency virus (HIV) viral load monitoring tests, postamendments class III devices with the product code MZF, into class II (special controls), subject toβ¦ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on November 4, 2022 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests From Food and Drug Administration (FDA) πΊπΈ Document number 2022-10461. The Food and Drug Administration (FDA, we, or the Agency) is issuing a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid (NAT) diagnostic and supplemental tests, postamendments classβ¦ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 16, 2022 Other (Public Domain) 0 reuses 0 favorites
Requirements for Medical Devices Marketing Authorization (MDS-REQ 1) From Saudi Food and Drug Authority (SFDA) πΈπ¦ Regulation outlining the requirements for marketing authorization of medical devices. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on December 19, 2021 Other (Public Domain) 0 reuses 0 favorites