{"product_id":"mda-class-a-product-registration","title":"MDA Class A product registration \u0026 AR Administration Fee","description":"\u003cp class=\"p1\"\u003e\u003cstrong\u003eA. MDA product registration for one (1) Class A medical device family. (per year)\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp class=\"p1\"\u003ePreparation and review of the required registration documents and technical information.\u003c\/p\u003e\n\u003cp class=\"p1\"\u003eSubmission to the Medical Device Authority (“MDA”) and liaison during the registration process.\u003c\/p\u003e\n\u003cp class=\"p1\"\u003eiElder to act as the Malaysian Authorised Representative, subject to execution of an AR agreement and\u003c\/p\u003e\n\u003cp class=\"p1\"\u003ereceipt of complete manufacturer authorisation and supporting documents.\u003c\/p\u003e\n\u003cp class=\"p1\"\u003eStorage support for the registered products.\u003c\/p\u003e\n\u003cp class=\"p1\"\u003eSales and distribution support under the 30% margin arrangement in Section 3.\u003c\/p\u003e\n\u003cp class=\"p1\"\u003eThis is per year rate\u003c\/p\u003e\n\u003cp class=\"p1\"\u003eB. \u003cb\u003eAuthorised Representative Arrangement (Per year)\u003c\/b\u003e\u003c\/p\u003e\n\u003cp class=\"p2\"\u003eThe product registration will be submitted and held under iElder’s applicable establishment licence as the appointed AR.\u003c\/p\u003e\n\u003cp class=\"p2\"\u003eThe manufacturer shall provide a valid Letter of Authorisation appointing iElder and execute the applicable AR agreement before submission.\u003c\/p\u003e\n\u003cp class=\"p2\"\u003eThe manufacturer\/customer remains responsible for the accuracy and completeness of product information, ongoing product compliance, and timely notification of any product, manufacturer, labelling, safety or regulatory change.\u003c\/p\u003e\n\u003cp class=\"p2\"\u003ePost-market surveillance, complaint handling, vigilance reporting, field safety corrective action, recall, renewal and change-notification work outside routine administration may be charged separately depending on the work required.\u003c\/p\u003e\n\u003cp class=\"p2\"\u003eThe ongoing AR appointment is subject to iElder’s establishment licence remaining valid and the\u003c\/p\u003e\n\u003cp class=\"p2\"\u003ecustomer maintaining all agreed commercial and regulatory obligations.\u003c\/p\u003e\n\u003cp class=\"p1\"\u003e \u003c\/p\u003e","brand":"iElder.Asia (Asian Integrated Medical Sdn Bhd 1016900-U)","offers":[{"title":"MDA registration per year","offer_id":48266836738274,"sku":"MDA1","price":2500.0,"currency_code":"MYR","in_stock":true},{"title":"Authorised Representative per year","offer_id":48266836771042,"sku":"MDA2","price":500.0,"currency_code":"MYR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0066\/3771\/5517\/files\/MDAregistration_1.png?v=1787726179","url":"https:\/\/ielder.asia\/en-vn\/products\/mda-class-a-product-registration","provider":"iElder.Asia (Asian Integrated Medical Sdn Bhd 1016900-U)","version":"1.0","type":"link"}