{"id":156,"date":"2019-08-28T19:28:08","date_gmt":"2019-08-28T19:28:08","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-news\/?p=156"},"modified":"2019-08-28T19:28:08","modified_gmt":"2019-08-28T19:28:08","slug":"medical-devices-who-needs-to-register","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-news\/2019\/08\/28\/medical-devices-who-needs-to-register\/","title":{"rendered":"MEDICAL DEVICES \u2013 WHO NEEDS TO REGISTER?"},"content":{"rendered":"\n

Establishments that are involved in the manufacturing and distribution of medical devices that are used in commercial distribution in the United States which includes import for export only devices are required to register with FDA<\/a> annually.\u00a0 <\/p>\n\n\n\n

As per 21 CFR Part 807, most establishments that are\nregistered with FDA are also required to list the devices with FDA.<\/p>\n\n\n\n

Below are the list of requirements for registration and\nlisting depending on the type of activity conducted in the establishment. <\/p>\n\n\n\n

Manufacturer<\/strong>:\n Establishments engaged in manufacture,\npreparation, propagation, compounding, and assembly or processing of a medical\ndevice intended for commercial market in the United States are required to\nregister, list and pay FDA fees. This also includes the manufacturers of accessories\nthat are packed or labeled for commercial distribution for health related\nissues to an end user, kit assemblers and also manufacturers of custom device\nand U.S establishment that manufactures for export only. <\/p>\n\n\n\n

Contract Manufacturer:\n<\/strong>Manufactures a finished device as per other establishment\u2019s\nspecification are called as contract manufacturer. Since contract manufacturer\nmeets the definition of finished device manufacturer they are also required to\nregister, list and pay FDA fees.<\/p>\n\n\n\n

Specification\nDeveloper: <\/strong>Specification developerare the ones who creates the specification for a device which are\nmarketed under the establishment\u2019s name but do not manufacture the device. In\naddition to that, they also arrange for the manufacturing of devices labeled\nwith another establishment\u2019s name by a contract manufacturer. Specification\ndevelopers are required to register, list with FDA and pay the fees. <\/p>\n\n\n\n

Contract\nSterilizer: <\/strong>Establishments that provide sterilization service for\nanother establishment\u2019s device are required to register, list with FDA and pay\nthe fees.<\/p>\n\n\n\n

Re-processor of\nSingle Use Device<\/strong>: Establishments that remanufacture single use device\nare required to register, list with FDA.<\/p>\n\n\n\n

Re-packager or\nRe-labeler<\/strong>: Establishments that packages finished devices from bulk or\nre-package devices manufactured into different containers are required to\nregister and list with FDA.  Also\nestablishments that changes the content of the labeling from the original\nmanufacturer for distribution under establishment\u2019s own name.<\/p>\n\n\n\n

Remanufacturer: <\/strong>Any\nperson or a firm who processes, refurbishes, conditions, repackages or does any\nother operation to a finished device that considerably changes the finished\ndevice\u2019s performance are required to register, list with FDA.<\/p>\n\n\n\n

Foreign Exporter<\/strong>:\nEstablishments in a foreign country that exports finished device to United\nStates for commercial distribution are also required to register and list their\ndevices with FDA.<\/p>\n\n\n\n

Initial Importer<\/strong>: Any establishment with a physical address in the United States which furthers the marketing of a medical device from a foreign manufacturer, who make the final delivery to the end user, but does not repackage or relabel or change the device package are required to register with FDA and also needs to identify the foreign manufacturer.<\/p>\n\n\n\n

All companies that register with FDA are required to renew their registration<\/a> and pay FDA fees for the following Fiscal year between Oct 1st<\/sup> and Dec 31st<\/sup> every year to keep their registration active.<\/p>\n\n\n\n

Liberty Management Group Ltd<\/a>, is a leading FDA consultant provides assistance with FDA registration, medical device listing and registration renewal and U.S agent<\/a> service for foreign facilities.<\/p>\n\n\n\n

Sudha S<\/p>\n\n\n\n

Regulatory Consultant<\/p>\n\n\n\n

Mail : office@libertymanagement.us<\/p>\n\n\n\n

http:\/\/www.fdahelp.us<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Establishments that are involved in the manufacturing and distribution of medical devices that are used in commercial distribution in the United States which includes import for export only devices are required to register with FDA annually.\u00a0 As per 21 CFR Part 807, most establishments that are registered with FDA are also required to list the … Continue reading “MEDICAL DEVICES \u2013 WHO NEEDS TO REGISTER?”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[27],"tags":[29],"class_list":["post-156","post","type-post","status-publish","format-standard","hentry","category-fda-registration-medical-device","tag-fda-medical-device-registration"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/156","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/comments?post=156"}],"version-history":[{"count":1,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/156\/revisions"}],"predecessor-version":[{"id":157,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/156\/revisions\/157"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/media?parent=156"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/categories?post=156"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/tags?post=156"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}