{"id":4138,"date":"2021-08-07T12:08:28","date_gmt":"2021-08-07T05:08:28","guid":{"rendered":"https:\/\/gmpgroups.com.vn\/solution\/tu-van-cong-bo-du-dieu-kien-san-xuat-trang-thiet-bi-y-te-2\/"},"modified":"2023-07-18T11:40:32","modified_gmt":"2023-07-18T04:40:32","slug":"consultancy-on-declaration-of-eligibility-for-medical-equipment-production","status":"publish","type":"mona_solution","link":"https:\/\/gmpgroups.com.vn\/en\/solution\/consultancy-on-declaration-of-eligibility-for-medical-equipment-production\/","title":{"rendered":"Consultancy on declaration of eligibility for medical equipment production"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">Medical equipment (TTBYT) is a special, essential item, present in every hospital and medical facility. For a country of more than 98 million people, the demand for medical equipment is huge. Since the covid epidemic situation has increased sharply, businesses have turned to manufacturing medical equipment partly to meet domestic supply, the other part to be able to overcome difficult times during the epidemic. Accompanying businesses operating in medical equipment, GMP Groups sends customers the content of advice to announce the eligibility to produce medical equipment in the country..<\/span><\/p>\n<h2><b>1. Why do you need advice to declare eligibility for medical equipment?<\/b><\/h2>\n<p>According to the current law, establishments\/enterprises may only produce medical equipment after they have been issued a receipt of dossiers of production eligibility by the Department of Health.<\/p>\n<p>Legal basis:<\/p>\n<ul>\n<li>Decree No. 36\/2016\/ND-CP on management of medical equipment<\/li>\n<li>Decree No. 169\/2018\/ND-CP amending and supplementing a number of provisions in Decree No. 36\/2016\/ND-CP on management of medical equipment<\/li>\n<li>Consolidated Document No. 01\/VBHN-BYT of the Ministry of Health: Decree on management of medical equipment, date of promulgation: 16\/03\/2020<\/li>\n<\/ul>\n<h2><b>2. Eligibility for application for a receipt for declaration of eligibility for medical equipment production:<\/b><\/h2>\n<p>Medical equipment are all kinds of equipment, tools, materials, implants, reagedies and in vitro standard materials, software that meets the conditions of diagnosis, prevention, monitoring, treatment &#8230; According to the regulations of the Ministry of Health, medical equipment is divided into 02 groups:<\/p>\n<ul>\n<li>Group 1 includes class A medical equipment &#8211; low-risk medical equipment<\/li>\n<li>Group 2 includes medical equipment of group B, C, D<\/li>\n<\/ul>\n<p>However, regardless of the group, the medical equipment production facility must meet the following conditions:<\/p>\n<h3><b>2.1. Eligibility for receipt of declaration of eligibility for medical equipment production for enterprises<\/b><\/h3>\n<p>In order to operate the medical equipment industry, customers first need to set up a business.<\/p>\n<p>In case the customer has had a previous enterprise, the company must be registered to operate the medical equipment manufacturing industry.<\/p>\n<p>In case the customer already has a company, however, the equipment factory is achieved differently from the head office of the company, the enterprise needs to establish a branch or business location at the address where the factory is located.<\/p>\n<h3><b>2.2. Eligibility for receipt of declaration of eligibility for medical equipment production for manufacturing establishments<\/b><\/h3>\n<p>&#8211; There are locations and area of production plants in accordance with the requirements of the type of medical equipment.<\/p>\n<p>&#8211; Production facilities must be certified iso 13485 quality standard<\/p>\n<p>&#8211; There is a system of production subdivisions<\/p>\n<p>&#8211; Having equipment and production process, quality inspection in accordance with the requirements of the type of medical equipment that the production facility produces.<\/p>\n<p>&#8211; The museum warehouse meets the preservation requirements of the equipment according to the instructions for use.<\/p>\n<p>&#8211; Facilities that meet fire protection and environmental conditions<\/p>\n<p>&#8211; Having means of transporting medical equipment from the production facility to the place of delivery in accordance with the type of medical equipment that the production facility produces.<\/p>\n<h3><b>2.3. Eligibility for medical equipment production vouchers for personnel<\/b><\/h3>\n<h3><b>a. Conditions of the person in charge of expertise:<\/b><\/h3>\n<p>The person in charge of expertise with a degree from a technical college of medical equipment or higher or a degree from a university majoring in engineering or majoring in medicine or pharmacy or higher. For medical equipment manufacturing establishments containing narcotics and precursors, the person in charge of expertise must have a university degree in medical equipment, medicine, pharmacy, chemistry or biology.<\/p>\n<p>&#8211; Have a direct working time on medical equipment techniques at medical equipment establishments for 24 months or more.<\/p>\n<p>&#8211; Working full-time at the production facility.<\/p>\n<ol>\n<li><b>Staff conditions<\/b><\/li>\n<\/ol>\n<p>There are staffs who meet the production requirements for the type of medical equipment that the facility produces.<\/p>\n<img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-1692\" src=\"http:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/08\/tu-van-iso-13485-san-xuat-trang-thiet-bi-y-te-1.jpeg\" alt=\"s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf\" width=\"900\" height=\"600\" srcset=\"https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/08\/tu-van-iso-13485-san-xuat-trang-thiet-bi-y-te-1.jpeg 900w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/08\/tu-van-iso-13485-san-xuat-trang-thiet-bi-y-te-1-300x200.jpeg 300w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/08\/tu-van-iso-13485-san-xuat-trang-thiet-bi-y-te-1-768x512.jpeg 768w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/08\/tu-van-iso-13485-san-xuat-trang-thiet-bi-y-te-1-450x300.jpeg 450w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/08\/tu-van-iso-13485-san-xuat-trang-thiet-bi-y-te-1-720x480.jpeg 720w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/08\/tu-van-iso-13485-san-xuat-trang-thiet-bi-y-te-1-675x450.jpeg 675w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/08\/tu-van-iso-13485-san-xuat-trang-thiet-bi-y-te-1-560x373.jpeg 560w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/08\/tu-van-iso-13485-san-xuat-trang-thiet-bi-y-te-1-210x140.jpeg 210w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/08\/tu-van-iso-13485-san-xuat-trang-thiet-bi-y-te-1-660x440.jpeg 660w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/08\/tu-van-iso-13485-san-xuat-trang-thiet-bi-y-te-1-600x400.jpeg 600w\" sizes=\"auto, (max-width: 900px) 100vw, 900px\" \/>\n<h2><b>3. Dossier of declaration of eligibility for production of medical equipment customers need to prepare\u00a0<\/b><\/h2>\n<p>&#8211; Certificate of business registration<\/p>\n<p>&#8211; ISO 13485:2016 quality management system certificate (with the scope of certification corresponding to production activities)<\/p>\n<p>&#8211; Confirmation of the working time of the organization operating medical equipment confirming to the personnel responsible for production at the facility (minimum confirmation period of 24 months)<\/p>\n<p>&#8211; Diplomas and training certificates of professional curators<\/p>\n<p>&#8211; Decision on appointment of the person in charge of expertise at the production facility<\/p>\n<p>&#8211; ID card\/CCCD\/Passport of the person responsible for production at the facility<\/p>\n<p>&#8211; List of equipment at the factory<\/p>\n<p>&#8211; List of personnel at the factory<\/p>\n<p>&#8211; Production process and product quality management<\/p>\n<p>&#8211; Test contract (if the facility does not have the capacity to check the quality to check the medical equipment that the production facility produces), the warehouse lease contract (if the facility does not have a storage warehouse), the transport contract (if the vehicle is a rental facility)<\/p>\n<h2><b>4. The process of applying for a certificate of eligibility for medical equipment production <\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Step 1: Prepare the application and submit the application to the Department of Health where the factory is located at the online page of the Ministry of Health:<\/span><a href=\"https:\/\/dmec.moh.gov.vn\/\"> <span style=\"font-weight: 400;\">https:\/\/dmec.moh.gov.vn\/<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p>Step 2: The expert receives the dossier, considers then issued an additional amendment (if the application is not valid), licensed (if the application is valid).<\/p>\n<p>Step 3: After being licensed, the Department of Health will publicize the information of the facility about the eligibility for TTBYT production.<\/p>\n<p>NOTE:<\/p>\n<p>Although it is submitted online, businesses also need to prepare a full dossier at the facility. Because after issuing the License, the Department of Health can set up a post-inspection team at any time.<\/p>\n<h2><b>5. GMP Groups Medical Equipment Manufacturing Eligibility Disclosure Service<\/b><\/h2>\n<h3><b>5.1. Services of GMP Groups<\/b><\/h3>\n<p>For start-ups in the medical field, the implementation of administrative procedures is often very difficult. GMP Groups provides customers with services to announce eligibility for TTBYT production including the following contents:<\/p>\n<p>&#8211; Free consultation on related issues before proceeding with the procedure.<\/p>\n<p>&#8211; Advising on preparation of dossiers and conditions to meet regulations on production of medical equipment.<\/p>\n<p>&#8211; Drafting dossiers, editing dossiers and carrying out procedures at competent state agencies on behalf of customers.<\/p>\n<p>&#8211; Carry out the procedures for publication at the Department of Health, monitor records, respond to dossiers if requested under your authorization.<\/p>\n<p>&#8211; Get the results and hand them over to the customer.<\/p>\n<p>&#8211; Assist in solving any problems that arise during the implementation process.<\/p>\n<h3><b>5.2. Why choose GMP Groups as a consultancy to announce eligibility to produce medical equipment?<\/b><\/h3>\n<p>We have made a lot of applications for vouchers to qualify for the production of medical equipment for customers. We are aware of the provisions of the decrees, documents on management of medical equipment as well as the order of application for receipts to ensure the quickest, COMPLETE AND MOST ACCURATE RECORDS.<\/p>\n<img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-1942\" src=\"http:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso.jpg\" alt=\"\u0110\u1ed9i ng\u0169 chuy\u00ean m\u00f4n t\u01b0 v\u1ea5n ti\u00eau chu\u1ea9n h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng\" width=\"1200\" height=\"800\" srcset=\"https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso.jpg 1200w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-300x200.jpg 300w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-1024x683.jpg 1024w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-768x512.jpg 768w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-450x300.jpg 450w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-720x480.jpg 720w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-675x450.jpg 675w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-560x373.jpg 560w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-210x140.jpg 210w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-660x440.jpg 660w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-600x400.jpg 600w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-354x236.jpg 354w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/>\n<p style=\"text-align: center;\"><em>The consulting staff announces the eligibility to produce medical equipment<\/em><\/p>\n<p>GMP GROUPS &#8211; NO. 1 SERVICE ANNOUNCES ELIGIBILITY TO MANUFACTURE MEDICAL EQUIPMENT IN VIETNAM.<\/p>\n<p><strong>GMP Groups Joint Stock Company<\/strong><\/p>\n<p><strong>Head office<\/strong>: Lot LK20.8, Ecoriver Eco-Investor, Hai Tan Ward, Hai Duong City, Hai Duong Province<\/p>\n<p><b>Hotline<\/b><span style=\"font-weight: 400;\">: 02203857968 ~ 0972345486<\/span><\/p>\n<p><b>Website<\/b><span style=\"font-weight: 400;\">: gmpgroups.com.vn<\/span><\/p>\n<p><b>Email<\/b><span style=\"font-weight: 400;\">: info@gmpgroups.com.v<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Medical equipment (TTBYT) is a special, essential item, present in every hospital and medical facility. In the context of the strong covid epidemic, businesses turned to manufacturing medical equipment partly to meet domestic supply, another part to be able to overcome difficult times during the epidemic. Accompanying businesses operating in medical equipment, GMP Groups sends customers the content of advice to announce the eligibility to produce medical equipment in the country.<\/p>\n","protected":false},"author":1,"featured_media":3626,"comment_status":"open","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"tags":[],"class_list":["post-4138","mona_solution","type-mona_solution","status-publish","has-post-thumbnail","hentry","category_solution-general-solution","category_solution-shared-cleanroom"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Consultancy on declaration of eligibility for medical equipment production<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/gmpgroups.com.vn\/en\/solution\/consultancy-on-declaration-of-eligibility-for-medical-equipment-production\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Consultancy on declaration of eligibility for medical equipment production\" \/>\n<meta property=\"og:description\" content=\"Medical equipment (TTBYT) is a special, essential item, present in every hospital and medical facility. In the context of the strong covid epidemic, businesses turned to manufacturing medical equipment partly to meet domestic supply, another part to be able to overcome difficult times during the epidemic. 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