{"id":414,"date":"2019-11-03T21:02:02","date_gmt":"2019-11-03T19:02:02","guid":{"rendered":"http:\/\/cratia.com\/?post_type=countries&#038;p=414"},"modified":"2020-11-18T17:21:08","modified_gmt":"2020-11-18T15:21:08","slug":"registracziya-mediczinskih-izdelij","status":"publish","type":"countries","link":"https:\/\/cratia.com\/en\/countries\/moldova\/registracziya-mediczinskih-izdelij\/","title":{"rendered":"Registration of medical devices"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">All medical devices prior to placing on the Moldavian market are subject to mandatory marketing authorization, which is performed:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">when the medical device has the CE marking: by notification,<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">when the medical device has not CE marking: by national conformity assessment and registration.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">In both cases foreign manufacturer must designate an Authorized representative at the territory of Moldova. Authorized representative must be a resident of Moldova, should have the relevant written authorization from manufacturer (Agreement and\/or Power of Attorney), has the right to initiate specific regulatory procedures and acts as a contact point between competent authorities and manufacturer.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Medical devices authorized to be placed on the EU market (having CE marking) undergo the simplified procedure for admission to the market by notification. The legislation determines that since such devices have already passed the conformity assessment, there is no need to repeat these procedures.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The device is placed on the market without the national SM conformity marking, however, before placing the product on the market it is necessary to perform a number of administrative procedures.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Medical devices that were not previously placed on the EU market must undergo the conformity assessment procedure in accordance with the legislation of Moldova, and then they are entered in the State register of medical devices. It is necessary:\u00a0<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">To designate the Authorized representative in Moldova, for which purpose the manufacturer must transfer the necessary rights to the resident legal entity of Moldova by means of the Power of Attorney or Contract;\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">To prepare national labeling and instructions for use (user manual);\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">To fill in and submit the Technical documentation, formed depending on the class of medical device;\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">To apply for registration of the medical device by notifying the Agency for medicinal products and medical devices;\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Place the national symbol (mark) of conformity \u201cSM\u201d.<\/span><\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p><b>Authorized representative of the manufacturer<\/b><\/p>\n<p><span style=\"font-weight: 400;\">If the manufacturer of the medical device is not a resident of the Republic of Moldova, then such manufacturer must designate the Authorized representative. The Authorized representative is designated by the Contract or Power of Attorney. The Authorized representative may be entitled to initiate conformity assessment procedures.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Responsibilities of the Authorized representative are:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">to place his name and address on the medical devices, which have passed the marketing authorization procedure;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">to register with the Agency for medicinal products and medical devices and to provide the description of the products that are the subject of his activities for entering data into Agency&#8217;s database;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">to receive information about incidents from the Agency and to take the necessary actions;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">to take the necessary actions in case of detection of medical devices without proper labeling;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">to keep the documentation and provide the Agency with access to it during 5 years from the time of placing the medical device on the market:<\/span>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">declaration of conformity;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">technical documentation;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">changes in technical documentation;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">decisions and documents of the conformity assessment body.\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><b>Package labeling and instructions for use (user manual)<\/b><\/p>\n<p><span style=\"font-weight: 400;\">The information on the product labeling may be indicated in the form of international symbols. The labeling of the medical device, the instructions for use (user manual) should be provided to users and patients in Romanian. Thus, on the labeling of the medical device that contains international symbols, it is necessary to indicate in Romanian:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">the name or brand name of the manufacturer, name and address of the authorized representative in the Republic of Moldova;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">the name of the medical device and other data necessary to identify the device and the contents of the package;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">if the device is made to order, the following should be indicated on it: \u201cdispozitiv fabricat la comand\u0103\u201d;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">if the device is intended for clinical studies, the following should be indicated on it: \u201cexclusiv pentru investiga\u0163ii clinice\u201d;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">any special conditions of storage and\/or handling;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">any special operational instructions;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">any warnings and\/or precautions to be taken;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">information that the product contains substances derived from human blood, if applicable.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The national conformity mark \u201cSM\u201d (Securitatea conform cerin\u0163elor esen\u0163iale Moldova) indicates that the manufacturer or his Authorized representative is responsible for placing this mark, has checked the conformity of the products to all main requirements applied in the technical regulations and that the products has been subjected to conformity assessment procedures provided by all applicable technical regulations.<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><span style=\"font-weight: 400;\">The graphic representation of the SM mark<\/span><\/td>\n<td><span style=\"font-weight: 400;\">The specifications (proportions) applied to the SM mark<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<table class=\" aligncenter\" style=\"height: 318px; width: 73.9028%; text-align: center; border-style: none;\" border=\"0\" cellspacing=\"5px\" cellpadding=\"5px\">\n<tbody>\n<tr>\n<td style=\"text-align: center; vertical-align: middle; width: 402px;\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-415 aligncenter\" src=\"https:\/\/cratia.com\/wp-content\/uploads\/2019\/11\/sm.png\" alt=\"\" width=\"135\" height=\"119\" \/><\/td>\n<td style=\"width: 432px; text-align: center; height: 24px;\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-416 size-medium\" src=\"https:\/\/cratia.com\/wp-content\/uploads\/2019\/11\/th_sm-300x201.png\" alt=\"\" width=\"300\" height=\"201\" srcset=\"https:\/\/cratia.com\/wp-content\/uploads\/2019\/11\/th_sm-300x201.png 300w, https:\/\/cratia.com\/wp-content\/uploads\/2019\/11\/th_sm.png 348w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/td>\n<\/tr>\n<tr style=\"height: 56px;\">\n<td style=\"width: 402px; height: 56px;\">\n<p style=\"text-align: center;\"><span style=\"font-weight: 400;\">The graphic representation of the SM mark<\/span><\/p>\n<\/td>\n<td style=\"width: 432px; height: 56px;\">\n<p style=\"text-align: center;\"><span style=\"font-weight: 400;\">The specifications (proportions) applied to the SM mark<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 400;\">The national conformity mark should be followed by the identification number of the conformity assessment body, if the specified authority has participated in the conformity assessment procedure. The identification number of the authority shall be placed by the authority itself, or, at the direction of that authority, by the manufacturer or his Authorized representative.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Cratia provides professional services of registration of medical devices in Moldova. We have an excellent knowledge of national legislation, necessary experience and resources.\u00a0<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: <a href=\"mailto:info@cratia.ua\">info@cratia.ua<\/a>, or visit <a href=\"\/en\/contacts\/\">our office<\/a>.\u00a0<\/span><\/p>","protected":false},"featured_media":0,"parent":145,"menu_order":3,"template":"","class_list":["post-414","countries","type-countries","status-publish","hentry"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/countries\/414","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/countries"}],"about":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/types\/countries"}],"up":[{"embeddable":true,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/countries\/145"}],"wp:attachment":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/media?parent=414"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}