Note for guidance on maximum shelf-life for sterile products for human use after first opening or following reconstitution From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - CPMP/QWP/159/96 corr. 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 June 4, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This is a guidance document titled "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." It focuses on premarket topics. 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 January 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Manufacture of sterile radiopharmaceuticals labelled with fluorine-18 From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance updated to reflect expectations of the new PIC/S guide to GMP PE009-13 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 June 30, 2023 Other (Non-Commercial) 0 reuses 0 favorites
CPG Sec. 300.400 Contamination of Devices Labeled as Sterile From Food and Drug Administration (FDA) 🇺🇸 This document is a Compliance Policy Guide (CPG) titled "CPG Sec. 300.400 Contamination of Devices Labeled as Sterile" and focuses on labeling and contamination of sterile devices. 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 May 3, 2021 Other (Public Domain) 0 reuses 0 favorites
Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products: Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on using container and closure system integrity testing instead of sterility testing for stability protocols of sterile products. 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 May 6, 2020 Other (Public Domain) 0 reuses 0 favorites
Notice on Strengthening the Supervision and Inspection of Sterile and Implantable Medical Devices by the Comprehensive Department of the State Drug Administration (SDA) From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2020-10001 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 March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments From Food and Drug Administration (FDA) 🇺🇸 A guidance document titled "510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments" for premarket topics. 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 17, 2020 Other (Public Domain) 0 reuses 0 favorites
General Administration on the issuance of single-use sterile syringes and other 25 kinds of medical devices production link risk list and inspection points of the notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2016-10205 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 March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
On the accreditation of Anhui Medical Device Testing Center for single-use sterile syringes and other medical equipment products and project testing qualification notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2012-10153 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 4, 2012 Other (Public Domain) 0 reuses 0 favorites
On the recognition of the Tibet Autonomous Region Food and Drug Inspection Institute for single-use sterile syringes and other medical equipment products and project testing qualifications notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2012-10071 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 February 29, 2012 Other (Public Domain) 0 reuses 0 favorites
On the accreditation of the Ningxia Hui Autonomous Region Drug Inspection Institute for single-use sterile syringes and other medical devices and project testing qualifications notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2011-10224 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 February 28, 2011 Other (Public Domain) 0 reuses 0 favorites
On the accreditation of Hunan Medical Devices and Pharmaceutical Packaging Materials (Containers) Testing Institute for single-use sterile syringes and other medical devices and project testing qualifications notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2010-10294 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 August 23, 2010 Other (Public Domain) 0 reuses 0 favorites
Notice on the accreditation of Shenzhen Medical Device Testing Center for single-use sterile syringes and other medical device products and project testing qualification From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2010-10554 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 August 23, 2010 Other (Public Domain) 0 reuses 0 favorites
On the accreditation of Sichuan Medical Device Testing Center for single-use sterile syringes and other medical devices testing qualifications notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2010-10240 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 July 5, 2010 Other (Public Domain) 0 reuses 0 favorites
On the accreditation of Anhui Medical Device Testing Center for single-use sterile syringes and other medical devices products and projects testing qualification notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2010-10172 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 December 30, 2009 Other (Public Domain) 0 reuses 0 favorites
On the accreditation of Hebei Provincial Medical Devices and Pharmaceutical Packaging Materials Inspection Institute for single-use sterile syringes and other 68 medical device products and project testing qualifications notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2009-10381 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 October 27, 2009 Other (Public Domain) 0 reuses 0 favorites
On the recognition of the Xinjiang Uygur Autonomous Region Food and Drug Inspection Institute on the one-time use of sterile syringes (with needle) and other 114 products and projects testing qualification notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2008-10234 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 December 10, 2008 Other (Public Domain) 0 reuses 0 favorites
On the accreditation of Chongqing Medical Device Quality Inspection Center on the one-time use of sterile syringes and other 130 products and projects testing qualification notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2008-10216 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 August 20, 2008 Other (Public Domain) 0 reuses 0 favorites
On the recognition of the Qinghai Provincial Drug Inspection Institute for single-use sterile syringes and other 13 medical device products and project testing qualifications notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2007-10171 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 November 28, 2007 Other (Public Domain) 0 reuses 0 favorites
On the recognition of the Henan Provincial Medical Device Inspection Institute for single-use sterile syringes and other 238 medical device products and project testing qualification notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2007-10242 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 November 26, 2007 Other (Public Domain) 0 reuses 0 favorites