medical device registration

  1. M

    Entering the Italian Market - Implantable Medical Device

    I have a Class IIb implantable device. I have identified a surgeon and centre in Italy who I would like to be the first to use the device. I will provide the initial devices free of charge. In this instance, do I need to register the device with the Italian MOH and do I need to provide...
  2. G

    Device Registration Ammendments - Modifications to Medical Devices

    I work for a US device manufacturer and oversee many projects that require modifications to devices. The devices have already been registered in the countries which we are now releasing the modification into. It's unclear (other than reading every country regulation under the sun) what the...
  3. M

    IVD Registration - Use of Prospective Study Data

    Hello all, It would be very helpful if you could address below query regarding the regulatory aspects of IVD device registration in South Africa, Kenya and Tanzania. Q1. Would it be possible to use prospective study data for in-country registration of an IVD? If yes, can you please let us...
  4. J

    Medical Device Registration in Argentina - Client asks us to provide “European FSC”

    Hello, Our factory is in China, and my Argentinian client asks us to provide “European FSC” for registration. I check ANMAT web site, the required document for procedure only shows FSC (apostille /consularized ) [ the original words: CLV vigente(apostillado/consularizado, traducido y...
  5. A

    Philippines Medical Device Registration Transfer

    Hello, anyone can help on below questions? I tried searching online but I could not find anything.. 1. Is multiple registration of medical device by different distributors for same product (Same brand) allowed in Philippines? 2. Can the registration be transferred from an existing...
  6. A

    Docs for Medical Device registration in China - List of certificates

    Hello everyone! Tell me please about a list of certificates which I should ask in chinese company to registration medical device in other country. It will be CFDA, FDA. What else?
  7. K

    Registering a Software medical device (SaMD) in China

    Hello, Does anyone know where I can find information (in English) on how one would register a software medical device in China? Thanks
  8. B

    How to certify a Class IIa Medical Device

    Hello, I have a product that would fall into class IIa. I would like to certify. Do you think that it is possible without much foreknowledge? Can the notfied body help with everything and is it then too expensive? What will change in May 2020? thanks best regards
  9. K

    510K Interactive Review

    We have had notification that our submission has passed through substantive review and that any discrepancies will be brought up during the interactive review process. AS far as I can see the deadline for interactive review is in two weeks time and we have yet to hear anything. Does anyone...
  10. F

    Class IIa/b in-country registrations x5 ?

    Hi all. We have two devices that we are wanting to sell within the following 5 countries: South Africa Iran Israel Kuwait UAE One of the devices is Class IIa and the other Class IIb (per the Medical Device Directive). I know some countries within the EU (my main focus) require additional...
  11. Gamula

    CFDA Biological Evaluation Report

    Dear Elsmar cove-dwellers, I hope that someone is knowing about te biological evaluation report, which has to be written in certain cases: "CFDA Notice on issuing guidance for Biological Evaluation and Review of Medical Devices (国食药监械[2007]345号). I received this because it shall be written...
  12. F

    Health Canada Registration : Company and/or 3PL ?

    Hi everyone. I'm hoping you can advise on another of my "I'm new to RA" related questions. I work for a global medical device/IVD manufacturer. One of our sites is based in Canada and they currently use a 3PL warehouse facility in Toronto to support with storage and distribution of products...
  13. S

    Uzbekistan - Medical Device Registration

    Hi All, Following our registration in Kazakhstan, my manager has asked me to look into registering our medical devices in Uzbekistan, and to check whether [company name] is "on the list", which I presume is the list of registered companies/medical devices within Uzbekistan. I've done some...
  14. L

    Can a hair transplant apparatus be CE-marked as medical device?

    It is a needle concerning Follicular unit extraction (fue) procedure for hair transplantation. I've seen some robotics used in hair transplantation have been regulated as medical device, i.e. in Canada. However, I'm not familiar with the European approach. Could you please help me?
  15. J

    MDR and Creative Clinical Evidence

    Hello all, This morning I watched a webinar which was about preparing for MDR. In the presentation, the speaker mentioned coming up with creative ideas to use for clinical evidence which would be less costly than clinical trials. She suggested possibly using focus groups, establishing a...
  16. L

    Can distilled water be certified as a medical device?

    I was wondering whether distilled water which is intended to be used for all general irrigation, washing and rinsing procedures; especially in surgical field (to be specific it will be used to rinse and wash surgical instruments). Thanks a lot :)
  17. rob73

    Worldwide device regulatory authorities at country level

    Hi All Found this and thought i would share WHO | Medical devices regulatory systems at country level
  18. V

    Submission for a cross-labelled combination product

    I am working on a cross-labelled combination product (the device and drug parts are manufactured and packaged separately but are both required to achieve the intended use). Doe anybody have experience with preparing a submission for a cross-labeled device? Do you prepare a DHF for the device and...
  19. M

    Audit Mandays for OBL/Virtual Manufacturer

    Hi guys, We have recently gotten our re-certification quote from the NB and they have quoted to audit us for 4 mandays. We a small company (OBL) with 10 ppl, five Class 1s devices and two Class II devices. When we asked the NB to justify the claim, they said that the number is derived by...
  20. Fatima444-4

    CLASS III - Preparing a registration dossier for a dermal filler

    Dear All , Good morning. Iam in the process of preparing registration dossier for a dermal filler. In Europe, it is classified as class III. I plan to submit the product to MENA region. I did not receive the master dossier yet from the supplier. In order for me to review the master dossier...
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