Field Properties

How To: Change Requests

RAPS RAC Holders

&nbsp;<figure class="table"><table><thead><tr><th style="vertical-align:top;">Property Name</th><th style="vertical-align:top;">Source</th><th style="vertical-align:top;">Description</th></tr></thead><tbody><tr><td style="height:15.0pt;vertical-align:top;">Country Name</td><td style="vertical-align:top;"><a href="https://www.iso.org/iso-3166-country-codes.html" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">The purpose of ISO&nbsp;3166 is to define internationally recognized codes of letters and/or numbers that we can use when we refer to countries and their subdivisions.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">ISO3166-1-Alpha-2</td><td style="vertical-align:top;"><a href="https://www.iso.org/iso-3166-country-codes.html" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">The purpose of ISO 3166 is to define internationally recognized codes of letters and/or numbers that we can use when we refer to countries and their subdivisions.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">ISO3166-1-Alpha-3</td><td style="vertical-align:top;"><a href="https://www.iso.org/iso-3166-country-codes.html" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">The purpose of ISO 3166 is to define internationally recognized codes of letters and/or numbers that we can use when we refer to countries and their subdivisions.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">Country Flag</td><td style="vertical-align:top;"><a href="https://www.iso.org/iso-3166-country-codes.html" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">The purpose of ISO 3166 is to define internationally recognized codes of letters and/or numbers that we can use when we refer to countries and their subdivisions.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">Continent</td><td style="vertical-align:top;"><a href="https://www.iso.org/iso-3166-country-codes.html" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">The purpose of ISO 3166 is to define internationally recognized codes of letters and/or numbers that we can use when we refer to countries and their subdivisions.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">Region Name</td><td style="vertical-align:top;"><a href="https://www.iso.org/iso-3166-country-codes.html" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">The purpose of ISO 3166 is to define internationally recognized codes of letters and/or numbers that we can use when we refer to countries and their subdivisions.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">Sub-region Name</td><td style="vertical-align:top;"><a href="https://www.iso.org/iso-3166-country-codes.html" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">The purpose of ISO 3166 is to define internationally recognized codes of letters and/or numbers that we can use when we refer to countries and their subdivisions.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">ISO4217-currency_name</td><td style="vertical-align:top;"><a href="https://www.iso.org/iso-4217-currency-codes.html" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">The purpose of ISO 4217 is to define internationally recognized codes for the representation of currencies that enable clarity and reduce errors.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">ISO4217-currency_alphabetic_code</td><td style="vertical-align:top;"><a href="https://www.iso.org/iso-4217-currency-codes.html" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">The purpose of ISO 4217 is to define internationally recognized codes for the representation of currencies that enable clarity and reduce errors.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">ISO4217-currency_symbol</td><td style="vertical-align:top;"><a href="https://www.iso.org/iso-4217-currency-codes.html" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">The purpose of ISO 4217 is to define internationally recognized codes for the representation of currencies that enable clarity and reduce errors.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">Dial</td><td style="vertical-align:top;"><a href="https://en.wikipedia.org/wiki/List_of_country_calling_codes" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">Dial prefixes for reaching telephone subscribers in foreign countries or areas via international telecommunication networks.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">is_independent</td><td style="vertical-align:top;"><a href="https://www.who.int/" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">Identifies if the country is independent or controlled by another country.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">Capital</td><td style="vertical-align:top;"><a href="https://www.worlddata.info/capital-cities.php" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">The capital city of the country.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">TLD</td><td style="vertical-align:top;"><a href="https://www.iana.org/domains/root/db" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">Top-Level Domain (TLD) for a country.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">Languages</td><td style="vertical-align:top;"><a href="https://www.iso.org/iso-639-language-code" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">The purpose of ISO 639 is to define Internationally recognized codes for the representation of the world's languages and language groups.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">WHO Website</td><td style="vertical-align:top;"><a href="https://www.who.int/" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">World Health Organization</td></tr><tr><td style="height:15.0pt;vertical-align:top;">MDSAP</td><td style="vertical-align:top;"><a href="https://www.fda.gov/medical-devices/cdrh-international-affairs/medical-device-single-audit-program-mdsap" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">Medical Device Single Audit Program (MDSAP)</td></tr><tr><td style="height:15.0pt;vertical-align:top;">ASEAN Member</td><td style="vertical-align:top;"><a href="https://asean.org/about-asean/member-states/" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">Identifies country membership.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">MENA Member</td><td style="vertical-align:top;"><a href="https://ustr.gov/countries-regions/europe-middle-east/middle-east/north-africa" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">Identifies country membership.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">EU Member Country</td><td style="vertical-align:top;"><a href="https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Glossary:European_Union_(EU)" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">Identifies country membership.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">EEA Member Country</td><td style="vertical-align:top;"><a href="https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Glossary:European_Union_(EU)" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">European Economic Area (EEA).&nbsp; &nbsp;Identifies country membership.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">IMDRF Member</td><td style="vertical-align:top;"><a href="https://www.imdrf.org/about/management-committee" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">International Medical Device Regulatory Forum (IMDRF).&nbsp; Identifies country membership.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">EU Candidate</td><td style="vertical-align:top;"><a href="https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Glossary:Candidate_countries" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">Identifies country membership.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">GHWP Member</td><td style="vertical-align:top;"><a href="http://www.ahwp.info/index.php/node/32" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">Global Harmonization Working Party (GHWP).&nbsp; Identifies country membership.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">AMDF Member</td><td style="vertical-align:top;"><a href="http://www.amdfnra.org/" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">African Medical Devices Forum (AMDF). Identifies country membership.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">Mercosur</td><td style="vertical-align:top;"><a href="https://www.mercosur.int/en/about-mercosur/mercosur-countries/" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">Identifies country membership.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">Eurasion Economic Union (EAEU) Member</td><td style="vertical-align:top;"><a href="http://www.eaeunion.org/" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">Identifies country membership.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">European Free Trade Association (EFTA)</td><td style="vertical-align:top;"><a href="https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Glossary:European_Free_Trade_Association_(EFTA)" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">Identifies country membership.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">CE Marking Accepted?</td><td style="vertical-align:top;">No Link</td><td style="vertical-align:top;">Identifies if the CE Mark is accepted as an initial market entry point. NOTE: Additional requirements may still be needed even if the CE Mark is accepted.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">US Embargo List</td><td style="vertical-align:top;"><a href="https://www.state.gov/economic-sanctions-programs/" target="_blank" rel="noopener noreferrer">Link</a></td><td style="vertical-align:top;">Identifies if the commercial distribution to the country from the US is restricted.</td></tr><tr><td style="height:15.0pt;vertical-align:top;">Data Confidence Rating</td><td style="vertical-align:top;">No Link</td><td style="vertical-align:top;">Data Confidence Rating is a qualitative rating that defines the “confidence” in the accuracy of the data. ⭐⭐⭐⭐⭐ = Publicly available resource content is robust, easily accessible, trustworthy sources established and documented, and frequently updated by members. ⭐⭐⭐⭐ ☆ = Publicly available resource content is mostly robust, easily accessible, trustworthy sources mostly established and documented, and frequently updated by members. ⭐⭐⭐&nbsp; ☆ ☆ = Publicly available resource content is fair, mostly accessible, several trustworthy sources established and documented, and occasionally updated by members. ⭐⭐&nbsp; ☆&nbsp; &nbsp;☆ ☆ = Publicly available resource content is low, not easily accessible, minimal trustworthy sources established and documented, and infrequently updated by members. ⭐&nbsp; ☆&nbsp; &nbsp;☆&nbsp; ☆ ☆ = Publicly available resource content is not readily available, cannot be easily accessible, limited to no trustworthy sources established and documented, and infrequently updated by members.</td></tr></tbody></table></figure>

Rimsys Intel was created with the community in mind, so we’re making it easy for users to submit proposed changes via Change Request Forms when they see information that has become outdated or is no longer valid on the Rimsys Intel website.<h2>Here’s how it works:</h2><h4>Create Change Request</h4><ol style="list-style-type:decimal;"><li>Click on the “Create" Change Requests button on the page that needs to be updated</li><li>Fill out the form with:&nbsp;<ol style="list-style-type:lower-latin;"><li>Basic contact information&nbsp;</li><li>The information you wish to update&nbsp;</li><li>Your proposed update&nbsp;</li><li>Your source(s) for this update&nbsp;</li></ol></li><li>Submit your Change Request Form (This will alert Rimsys of a New change request)</li></ol>You can also watch our short video to learn how to create and submit a change request: <a href="https://www.loom.com/share/5af291ba75404f308362da5fe910b17c?sid=38df81fc-b855-4f34-9eb3-2e6583b6d787" target="_blank" rel="noopener noreferrer">Submit a Rimsys Intel Change Request</a>.<h4>Formal Review</h4>Rimsys subject matter experts will peer review your change request and the source you used to validate the information provided. You’ll see the status as Pending until the review is complete and Approved, Approved (Partially), or Rejected once we finish the review. Rejected requests will have a reason for not being approved.<h4>Approval / Rejection</h4>When a change request is approved, a Rimsys team member will make the respective update on the Rimsys Intel site.&nbsp;Once your update is live, you will receive an email. Your update will also be populated in a change request feed so that all users can see recently changed information.&nbsp;Please note that you must submit one change request per proposed update, but you can submit as many as you need to.<hr><h2 style="text-align:center;">Frequently Asked Questions</h2>Got a question? We've got answers. If you have some other questions, contact us by email.&nbsp;Why did my Change Request get rejected?This can happen for several reasons, but primarily, it is related to not having a valid reference, inadequate information, and incomplete required form fields, among others.Can I cancel a Change Request once it's been submitted?Once a Change Request is submitted, you can no longer update it. If you wish to cancel an existing request, please reach out to <a href="mailto:intel@rimsys.io" target="_blank" rel="noopener noreferrer">intel@rimsys.io</a> with a description of the change request.I made a mistake. How do I update my Change Request?Once a Change Request has been submitted, you can no longer update it. Please ensure that prior to submitting, all information is as accurate as possible to avoid a rejection. You can contact us intel@rimsys.io for additional information.

We know how important it is to stay current on regulatory updates while empowering others in the community with the knowledge they need to make informed decisions about their medical technologies. That's why we are excited to offer RAPS Regulatory Affairs Certificate (RAC) holders a free opportunity to earn recertification credits by reviewing Rimsys Intel. Five hours of Rimsys Intel review is equivalent to five RAC recertification credits. Here's how you can earn your credits:Step 1: &nbsp;Sign Up and Complete Your Rimsys Intel ProfileSign up as a Rimsys Intel user and set up your profile. Make sure you include your RAPS member ID and LinkedIn URL so that we can verify you're part of the RAPS community.Step 2: &nbsp;Review the Rimsys Intel SiteReview the intelligence data on Rimsys Intel to help us keep it up to date. RAC holders are expected to complete 5 hours of Rimsys Intel review in exchange for 5 RAC credits.Step 3: &nbsp;Submit a Change RequestWhen you see information that needs to be updated, submit a change request with your references and any attachments as necessary. Rimsys will review your request and put it through our approval process.Step 4: &nbsp;Earn Recertification CreditsRimsys subject matter experts will use the following criteria to assess each change request: level of research and supporting documentation submitted with the change request, the thoroughness of the change request, and the complexity of the proposed change. Rimsys will work with RAPS to ensure the 5 recertification credits are issued once an RAC holder has met the 5-hour review requirement. Please note that RAC holder review hours must be completed by 12/31/24 to receive recertification credits from RAPS.<hr>Have a question about our collaboration with RAPS RAC holders? Email us at <a href="mailto:intel@rimsys.io">intel@rimsys.io</a>.&nbsp;

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How To: Change Requests

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