adverse event reporting

  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. 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
  3. Q

    FDA 3500A Reports - Trip and Fall - Weight scale with a fold out platform

    Scenario: a weight scale that has a fold out platform that you stand on when weight is being taken. If the platform was left in the down position and someone tripped and fell on it and had a serious injury is it required to report to the fda (3500A) as the manufacturer? regards, qu1nn
  4. F

    Guidance in English for PMS requirements for Taiwan

    Hi, I am unable to find the Guidance in English for PMS requirements for Taiwan. Does anyone have this translated or a similar presentation or template procedures for adverse event reporting and field corrections in Taiwan, I would be greatly appreciative. Thanks!
  5. Marcelo Antunes

    Medical Device News Olympus Medical pleads guilty to failing to file events notice: Justice Department

    Continuing with the duodenoscope topic: Olympus Medical pleads guilty to failing to file events notice: Justice Department. Continuando com o tema do duodenoscópios: Olympus Medical pleads guilty to failing to file events notice: Justice Department. Continue reading...
  6. S

    MAUDE database and similar devices

    Hi everyone, The MAUDE database can be used to search adverse events for different product codes. One question came up as I was doing some risk analysis for a particular product code. As part of risk analysis, I was told that we can search for product codes. What does it mean by similar...
  7. FoGia

    IMDRF opened a Consultation on Annex E & F and the link to ISO 14971

    Hello, IMDRF opened a consultation regarding annex E & F on their draft guidance related to health effects. According to their guidance, adverse events ought to be classified following their clinical signs, symptoms and conditions on one hand and following their health impact on the other...
  8. S

    Adverse Event and Serious Adverse Event Reporting - Korea

    Hi All - There is a new regulation from MFDS, Korea on reporting Serious Adverse Events occurred globally. Can someone confirm my understanding: - If a medical device is registered in S.Korea, then adverse events (AE)/serious adverse events(SAE) occurred in-country will be reported to MFDS. -...
  9. Q

    U.S. Agents - Responsibility for reporting adverse events to the FDA

    Good morning fellow Cove-ers We are a Canadian medical device company who currently uses a U.S Agent as required for any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States. Upon review of our...
  10. I

    Adverse Event Reported during Non-Approved Indication Use

    One of our clients is using a device he purchased to us to perform a clinical trial outside our CE mark indications. He is the sponsor and the investigator, we are not involved in his activity at all. However he has reported us an adverse event (no SAE). This event is not related to the...
  11. 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...
  12. I

    Where to submit Adverse Events Reports in Europe

    Hello all I'm getting a bit confused with regards to where we need to submit adverse event reports in Europe.... We are a UK based company BSI is our notified body MHRA is our national competent authority We sell our devices into multiple countries in Europe As an example. if we...
  13. 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...
  14. A

    Accessing Medical Device Adverse Event databases in EU

    Is there any means to access adverse events database in EU? Basically, in EU, what is comparable to MAUDE database (US)? Thanks, Pooja
  15. B

    Changes in Medwatch Reporting Requirements

    Can anyone shed some light on what types of medical device complaints need to be reported? Years ago we used to only report adverse incidents that was caused or contributed by our medical device. Now that I am working for a different company, this company's policy is to report any incident...
  16. R

    Reporting Times & Requirements for when an Adverse Event has occurred (Japan)

    Hi all. Could anybody help me with the reporting times / requirements for when an adverse event has occurred with a medical device in Japan. There are a couple of IMDRF/GHTF documents that might help me... but the fact that there are more than one, with different information in doesnt help...
  17. Z

    Kyrgyzstan Medical Device Classification and Registration Requirements

    Hello everyone :bigwave: i'm searching for registration requirements for Kyrgyzstan and i hope you can help me a little bit :( I can find very different information about the requirements. Unfortunately i only find the law of medical devices in russian and can't understand anything! Maybe...
  18. S

    AHWP Guidance on Adverse Event Reporting for Comments

    Hi All, AHWP has released a draft guidance on Adverse Events and seeking comments from the Industry. More details about AHWP are available at the below link: Regards, Sreenu
  19. M

    Major Revision to FDA Adverse Event Reporting

    From QMN Weekly Bulletin: My understanding is that some device makers will see a significant difference in the system, in that FDA will follow up faster both on manufacturer reports received, and on manufacturer reports not received when FDA learns of a potentially reportable event through...
  20. S

    Singapore - Revised Adverse Event reporting and FSCA Reporting Guidance

    Hi All, Singapore Health Sciences Authority (HSA) has provided the updated guidance and forms for Adverse Event reporting and FSCA Reporting. Especially, more clarity is given on reporting and a flow chart of reporting with updated Forms. Attached is the guidance. Regards, Sreenu
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