Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.

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Page 1 of 4 1 2 3 4 > Japan Medical Device Regulations - Discussion Threads Forum Tools Search this Forum   Rating Discussion Thread Title / Thread Starter Last Post or Poll Vote Replies Views Medical Devices in Japan - Conformity of QMS to ISO 13485 JeantheBigone started this discussion on 15th August 2018 9th September 2018 08:02 PM by v9991 1 114 Looking for English Copy of MHLW 169 regulation Sue789 started this discussion on 31st October 2017 15th August 2018 10:46 AM by JeantheBigone 5 1,514 GHTF Incidents - What does unlabeled and labeled mean? ( 1 2) jkc3usc started this discussion on 3rd April 2018 14th August 2018 08:18 AM by mylenerr 9 804 Scope change in Japan - Class I disposable medical devices smartinez started this discussion on 11th July 2018 11th July 2018 12:11 PM by smartinez 0 366 Are English translations required for Japanese Certs medic61 started this discussion on 10th May 2018 11th May 2018 04:14 AM by shimonv 1 572 Japan AE (Adverse Event) Reporting Requirements jinglot started this discussion on 20th June 2017 11th April 2018 07:33 AM by jkc3usc 3 3,003 Request for Information; Application for Accreditation bender991 started this discussion on 10th April 2018 10th April 2018 03:49 PM by bender991 0 248 JIS T 1115 Comparison (Japan Medical Device Standard) QM Becky started this discussion on 22nd March 2018 22nd March 2018 11:49 AM by QM Becky 0 257 Japan's Definition of Should and Shall jiligan started this discussion on 31st October 2017 1st November 2017 08:19 AM by Ajit Basrur 1 1,106 UDI requirements vs Japanese Barcode Marking guideline iVivien started this discussion on 12th June 2015 3rd October 2017 03:12 PM by miken99 1 2,456 Does Japan accept the Bracketing Approach for Process Validation CSH_3 started this discussion on 26th April 2017 26th April 2017 08:53 AM by redmonkey2 1 1,666 Japan MHLW Ordinance No 94. (QMS structure Regulation) pdzip2 started this discussion on 12th April 2017 24th April 2017 03:09 AM by Marc 1 1,648 Content of an IVD Technical Dossier to Register a Device to Japan Pythagore started this discussion on 2nd March 2017 2nd March 2017 04:53 AM by Pythagore 0 1,353 Source for The Enforcement Regulations in English - Article 228-20 enrevanche started this discussion on 31st August 2016 19th December 2016 02:51 PM by jmendezlsat 7 3,079 IVD Classification in Japan based on the Japanese Pharmaceutical Affairs Law esh14 started this discussion on 18th September 2016 5th October 2016 09:41 PM by esh14 2 2,071   Linked: KGMP (Korean GMP requirements) vs. ISO 13485 johnq98 started this discussion on 19th September 2016 - - - How does Japan PMDA classify Medical Devices - Classification Guidelines Arnthor started this discussion on 21st October 2011 30th August 2016 06:48 AM by woudeniv 6 6,697 Japan Medical Device Labeling Requirements ArunGokul307 started this discussion on 1st August 2016 15th August 2016 07:28 PM by QAengineer13 5 3,240 PMDA Act, Nov 2014 revisions - source in English? enrevanche started this discussion on 16th May 2016 26th July 2016 04:09 PM by enrevanche 3 2,157 IVD device distribution, what to do? Paperman started this discussion on 28th June 2016 29th June 2016 07:27 AM by TroutBrook 1 2,290 Page 1 of 4 1 2 3 4 > Lower Navigation Bar   The Elsmar Cove Business Systems and Standards Discussion Forums > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations Japan Medical Device Regulations Display Options Moderators Showing threads 1 to 20 of 76 Moderators : 2 Sorted By Thread Title Last Post Time Thread Start Time Number of Replies Number of Views Thread Starter Thread Rating Sort Order Ascending Descending From The Last Day Last 2 Days Last Week Last 10 Days Last 2 Weeks Last Month Last 45 Days Last 2 Months Last 75 Days Last 100 Days Last Year Beginning   Marcelo Antunes, Ajit Basrur  Forum Tools Search this Forum Mark This Forum Read View Parent Forum Search this Forum : Advanced Forum Search Search this Forum Show Threads   Show Posts Advanced Forum Search New posts Hot thread with new posts No new posts Hot thread with no new posts   Forum Posting Settings You may not post new threads You may not post replies You may not post attachments You may not edit your posts BB code is On Emoticons are On [IMG] code is On HTML code is Off Forum Rules