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

regulations and regulatory requirements

  1. M

    Exemption Clauses for Research, Demonstration, etc.

    Hello All, I am hoping to compile in one place references to various exemption clauses, that allow for regulation exemptions in cases of, for example, devices used for research/investigative purposes, or demonstration/trade-fair purposes. This thread could also be used to discuss the specific...
  2. Marcelo Antunes

    Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia

    TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Continue reading...
  3. Marcelo Antunes

    Pharmaceuticals News UK – Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal

    Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal Continue reading...
  4. M

    Challenges Incorporating Mobile Devices into Medical Devices

    I'd like to start a thread to discuss challenges associated with incorporating mobile devices into medical devices. There are several applications: Mobile device is intended to replace an existing wireless controller. This was discussed briefly in another thread. Mobile device used to...
  5. Marc

    Interesting Topic We have food safety laws thanks to 19th century “poison squad”

    The "Poison Squad" Excerpt: "Dairy suppliers were among the worst offenders, adding pureed calf brains to milk to make it look more like rich cream, thinning the milk with water and gelatin, and then adding dyes, chalk, or plaster dust to correct the color. Worst of all, they added...
  6. K

    Moist Heat Sterilization worldwide Requirements and Regulations

    I need to find out the variety in local requirements for moist heat sterilization throughout the world. Client is selling laser equipment and accerssoiries in many countries with some items that need to be re-sterilized in the hospital. Issue is that next to the ISO standards individual...
  7. M

    Strategy for Foreign Regulatory Compliance

    Hoping to start a discussion on how companies handle regulatory compliance where regulations are only available in foreign languages (so you cannot read/interpret the requirements for yourself, do gap analysis, etc.). Here are some initial points of discussion: 1. Consultants Obviously, if you...
  8. M

    Medical Device News Health Canada Notice of intent: Strengthening the post-market surveillance and risk management

    Health Canada issued this notice of intent back in April regarding "Strengthening the post-market surveillance and risk management of Medical Devices". As written in the notice, most of the proposed changes are written in the format "Provide the Minister with the authority to...". Does this...
  9. R

    How to keep track of all FDA rules and regulations for medical device companies

    Is it just me or is there anyone else having difficulties keeping track FDA rules and regulations for medical device companies. The company I work at is going to apply for FDA 510k and CE mark. We follow all the guidelines, but it is getting harder and harder to keep track of all requirements...
  10. S

    We are planning to sell a Medical Device Group

    We are planning to sell a medical device group, consisting of individually licensed devices (both Class II), made by the same manufacturer. The regulation and guidance explain that we do not need to apply for another licence because the group is deemed licensed if the individual products are...
  11. M

    Is "Made in (Country)" a labelling requirement?

    Just wondering if anyone can point to any medical device regulation that requires a label to state "Made in [Country]"? Presently, our labelling includes this text, but I'd like to remove it if possible to avoid having to translate the English text. My justification is that we already use...
  12. C

    Where to buy the latest MHLW, Canada MDR, Brazil medical device regulations

    Hello, Is there one website that I can get, buy, download the latest MHLW, Canada MDR, Brazil regulations for medical devices? Or if you have the sites you use for each one will be fine too. Thank you,
  13. N

    Triple insulated wire for transformer isolation

    Hi, This is my first post here but I was hoping for some advice. I am redesigning a power supple for a piece of medical equipment, which is subject to 60601 Pt 1 and Pt 2.2. The transformer is subject to a dielectric stress test of 3kV AC 50Hz. I am considering using triple insulated wire as...
  14. Q

    Minor non-conformance for not controlling local regulation laws?

    Hello everyone. An external auditor auditing compliance with 9001 2015, raised me a minor nc for not referencing anywhere into my qms other standards apart from Iso 9001. The point is, in my policy I state " complying with legal and statutory reglamentation " just to say that if I'm...
  15. Edward Reesor

    Role of increased regulatory costs in increasing risk

    :notme: Now here's a "fun" discussion topic that came up in our office. I was explaining to our staff how our company is responsible to track the entire lifespan of our product from design to contract manufacturing, shipping, distribution to final disposal - all in the name of patient...
  16. F

    New to RA: FDA Regulation Checklist/Gap Analysis

    Hi all, I'm relatively new to RA but worked within IVD manufacture for nearly 10 years. I work for a medical devices company and I've been tasked with leading a gap analysis of our quality management system against the FDA regulations (CFR 820 Part 21?), in preparation for us applying for...
  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. Sidney Vianna

    IAF Endorsed Accredited 13485 Certification helping Control of Medical Distributors

    Cover Grant Ramaley is the author of an article available at the IAF website: Read the whole article here.
  19. A

    EASA Easy Access Rules for Continuing Airworthiness - June 2017

    EASA has jut released a set of consolidated regulations that might be helpful to visitors. It is a handy online resource that shows the current amended rules, and for each 145 regulation the Acceptable Methods of Compliance and Guidance material. There is also a good set of guidance material...
  20. Marcelo Antunes

    MDR and IVDR to be published May 5th 2017

    Seems like the new European regulations for medical devices will be published this Friday....
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