Can YOU help? --> Unanswered questions <-- (Other than Marcelo's Informational posts)


  1. A

    Japan's Requirements for Reporting Medical Device Adverse Events

    Any information on the Japan requirements for reporting adverse events? Any decision trees available?
  2. Ajit Basrur

    Refurbisher of medical devices in Japan

    Is it mandatory for a refurbisher of medical devices in Japan to be ISO 13485 certified? I am searching for this requirements in Japanese regulations but did not find it. Thank you!
  3. F

    Vietnamese Post-Market Surveillance Requirements for a medical device in Japan

    Hi, Anyone can please help out on what the adverse event reporting and recall requirements are for a medical device in Japan! Thanks, Deanna
  4. A

    Certification procedure for OEM/PLM collaboration in the medical device industry in the US - Who bears the regulatory responsability?

    What is the certification procedure for OEM/PLM collaboration in the medical device industry in the US? Who must bear the regulatory responsability?
  5. supadrai

    Informational Japan Minor Change Notification Application Form - Found it?

    Hi All, This MCN form took me ages to track down, can anyone confirm? Google translate seems to confirm it is what I think it is. But is this the Form No. 6 referenced in the official "Application for Accreditation of Foreign Manufacturers" published by the PDMA PMDA. (both attached)...
  6. I

    Japanese medical device recall requirements & procedure for foreign manufacturers

    Dear forum, I am trying to find out how medical devices are recalled in Japan for a European manufacturer. Could someone please post the procedure or a link? Best regards, Delvyn
  7. J

    Medical Devices in Japan - Conformity of QMS to ISO 13485

    I'm looking for confirmation of something I think is the case with regard to conformity of the QMS of a manufacturer marketing a device in Japan to ISO 13485. Since I can't read Japanese, I'm not 100 % positive that the following is true, but here goes...... Japan does not currently require...
  8. S

    Scope change in Japan - Class I disposable medical devices

    Hello all, first time poster long time lurker. I was wondering if anyone has had experience adding to their scope in Japan. We currently have approval for class I disposable devices in Japan and want to add repairs to our scope. I have been looking around the internet but have been coming...
  9. M

    Are English translations required for Japanese Certs

    Hello all, long time away from here but hope you can help. Getting ready for MDSAP audit. Consultant says our customers quality certs need to be formally translated into English by the originator, not the customer. I need to find where this is written. Thanks!
  10. Q

    JIS T 1115 Comparison (Japan Medical Device Standard)

    Hi All, I am stumped at the moment regarding a Japanese standard (specifically JIS T 1115) but the question is generic in case you aren't familiar with that particular standard. With respect to the Japanese standards, does anyone know of a good site or collection of data comparing the...
  11. J

    Japan's Definition of Should and Shall

    Does the definitions of should and shall mean the same for Japans MHLW and PMD Act requirements for medical devices as it does in ISO 13485:2016? Where can I find these definitions? :thanx:
  12. S

    Off-Label Use of a Medical Device in Japan

    Here is an interesting one... A physician from Japan is interested to buy a medical device which is not cleared in Japan. Most probably it will be used for research & trials. Any tips on how the manufacturer can cover himself from liability and what to declare for the customs? Would be nice...
  13. J

    Japan AE (Adverse Event) Reporting Requirements

    Hi! I am finding conflicting information online and not much in English regarding reporting requirements in Japan. Some main questions: 1. Are AEs outside of Japan reportable to PMDA? 2. Are AEs that are already provided in labeling reportable? If anyone has a decision tree that they are...
  14. C

    Does Japan accept the Bracketing Approach for Process Validation

    hello I hope this is a simple yes or no answer? Please can anyone advise if Japan accept the bracketing approach for process validation. As I am looking at registering some products? :bigwave: Many Thanks
  15. P

    Japan MHLW Ordinance No 94. (QMS structure Regulation)

    Can anyone make an english copy of the MHLW ordinance No 94 (Taisei Syorei or QMS Structure Regulation available for download)? It is referenced in an Emergo paper of October 2016 titled "Japan Ordinance 169 and Medical Device QMS Requirements" with subtitle Conformity assessment routes and...
  16. B

    Where can I find an English version of Japan's PMD Act?

    Does anyone know where I can find an English version of Japan's PMD Act? Thanks!
  17. P

    Content of an IVD Technical Dossier to Register a Device to Japan

    Hello everybody, I am searching details on the content of a IVD technical dossier to register a device to Japan. To be more specific: all the data that are necessary and their presentation (reproducibility, comparison method, LoB, LoD, sensitivity ...). Thank you very much for all your help.
  18. E

    IVD Classification in Japan based on the Japanese Pharmaceutical Affairs Law

    Hi everyone, I would like to ask about the IVD classification system in Japan. I have read through a few sites and found out that the classification for IVD instrument and IVD reagent are categorized under two different systems (medical device & drug) based on the Japanese Pharmaceutical...
  19. E

    Source for The Enforcement Regulations in English - Article 228-20

    Through the good offices of several members of this forum, I was able to obtain an English translation of the 2014 revisions of MHLW Ministerial Ordinance No. 169. I hope you will be able to help me with my latest request. :rolleyes: Adverse event reporting is covered by Article 69 of MHLW...
  20. A

    Japan Medical Device Labeling Requirements

    Dear all, Do anyone know what are the languages Japan Regulatory body is going to accept in the instructions for use? Can we add any additional languages apart from the specified languages? Thanks in advance. Best regards, Arun
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