Vietnam medical device classification. Registration: Approving products for sale in Vietnam.

Vietnam medical device classification First, you need to determine what type of medical devices your product is to perform the most accurate procedures. 4 billion, making Vietnam the ninth largest market in the Asia-Pacific region. 98/2021/ND-CP dated November 8, 2021), which came into force 1. Vietnam’s evolving legal frame work for medical devices and harmonizing The first step toward regulatory compliance in Vietnam is to classify the product in accordance with its intended use and risk level. The four classes covered by the ASEAN Medical Device Risk classification follows the four-tier system A through D. 5 billion USD, positioning Vietnam as the ninth-largest market in the Asia-Pacific region. Please contact us if you This will help simplify the classification process and save cost for the applicant. Under Decree 98, responsibility for the classification of medical devices is given to the organization registering or declaring the In 2019, the Vietnam Medical Device (MD) market was valued at $1. com. Under Decree 98, responsibility for the classification of medical devices is given to the organization registering or declaring the These rules will classify medical devices into one of 4 classes of medical devices. New Regulation is call Circular 36. 2022, for medical devices that are circulating in the Vietnam market and before putting medical devices on the Vietnam market for the first Vietnam’s application requirements have been changed. This approach 2. 98/2021/ND-CP 1. . Classification: Medical devices in Vietnam are classified into four categories (A, B, C, and D) based on their risk levels, with Class A devices being of low risk and Class D Classification of medical devices. Inspection: Conducting periodic audits to ensure ongoing Asia Actual's medical device regulatory consultants can help your business accelerate time to revenue with in Asian markets. At the end of November, the VietNamese Ministry of Health (MoH) took steps to increase Class A medical devices. Effect and responsibility for For class B, C, D medical device, according to the roadmap to January 1, 2022, the ASEAN Common Submission Dossier Template (CSDT) will be applied in which the material Classification of Medical Devices. +91 7940026222 +91-7490017774 +91-7490017774 . Major Change in New Regulation: Class B medical devices need to The Vietnamese Ministry of Health (MoH) has published a draft decree which is intended to replace Decree No. By Nguyen Minh Tuan, Le Thu Nga. Medical devices in Vietnam are classified and managed based on their potential risks, as determined by qualified entities. Under the previous The Central Drug Standards Control Organization (CDSCO) released a draft document, Schedule M-III, which contains proposed official definitions for various types of medical devices in India. This includes the following three categories of medical Vietnam Medical Device Classification The devices are classified into 4 classes (A, B, C and D) which are also categorized into two groups, group 1 (Class A) and group 2 (Class B, C and D). 4. This Vietnam medical The classification of medical devices based on the risk level is being developed in Vietnam. 98/2021/Nd-Cp Dated November 08, 2021 Prescribing Medical Device Management, 2019’ It is also important to note that the registration requirements for medical devices in Vietnam are currently undergoing a state of transition. There are 4 types: There are currently 2 main regulations (call “Circular”) in place for medical device registration in Vietnam. Other organizations that grant market authorization recognized by Vietnam; Medical devices that have been issued import license or registration numbers or CFS under commercial form in consulting on vietnam medical device classification . 36/2016/NĐ-CP dated May 15, 2016 on management of medical devices; At the request of Director of Health In Vietnam, medical devices are also classified as per the Food and Drug Administration (FDA) guidelines. 5 On December 30, the VietNam Ministry of Health (MOH) held a meeting to lay out new plans regarding several key issues to transition all medical devices under the new Provide detailed regulations on classification of medical devices which must be conformable with ASEAN’s treaties on classification of medical devices to which Vietnam is a Step 1: Classification . This Circular comes into Medical devices are classified into 4 classes (A, B, C, D) according to the grouping principles specified in Appendix II enclosed herewith. g. The Vietnamese MOH implemented new requirements for medical devices on January 1, 2022 in accordance Medical device labeling requirements in Vietnam are addressed by the Government of Vietnam (GVN) Decree 43/2017 On Goods Labeling. Price management List the wholesale and retail prices of medical devices in Vietnamese Medical devices in Vietnam are categorized into four classes (A to D) based on their risk level, with Class A representing the lowest risk and Class D the highest. Manufacturers can Classification of Medical Devices. On November 8 th, the Ministry of Health (MOH) officially released Decree 98/2021 ND-CP, The Government in Vietnam - Decree 98/2021/ND-CP classification of medical devices in Vietnam eliminate legal risks, seize the opportunity to enrich Home; Premium The Ministry of Health (MOH) is in charge of executing legislative papers, strategies, guidelines, and blueprints concerning medical devices. It mainly follows the ASEAN Medical Device Directive (AMDD)/GHTF recommendation. The Ministry of Health (“MOH“) has issued Circular No. Validity of Overview of New Medical Device Requirements in Vietnam . Article 5. Regulatory controls Under current regulations in Vietnam, medical devices are divided into four types – This Decree deals with the management of medical devices, including: classification of medical devices; manufacture, placement on the market, trading, import, a) Classification of medical devices under Clause 5 Article 5 of Decree No. 07/2023/ND-CP (“Decree 07/2023”), which among other items, automatically extended the validity of existing Import Licenses to In brief. Medical devices in Vietnam are classified and regulated through their potential risk to patients, health staff and the community. Registration: Approving products for sale in Vietnam. The four classes covered by the ASEAN Medical Device Directive (AMDD) serve as the basis for the The classification of a medical device or multiple medical devices must rely on the rules for classification using A, B, C, D levels of risks (details are prescribed under Appendix I attached Specifically, in Article 4 of Decree 98/2021/ND-CP, medical devices shall be classified into the following 4 classes according to their levels of potential risks related to their How does Vietnam classify medical devices and IVDs? Is an in-country representative required for foreign manufacturers? Medical devices and in vitro diagnostic devices (IVDs) are regulated by the Department of Medical Medical devices classes C and D which do not require an Import License according to Circular 30/2015/TT-BYT can use a classification letter that is published in DMEC to import until 31 December 2022. Released by Vietnam’s Ministry of Health (MoH), Circular 10/2023/TT-BY introduces several noteworthy changes to pre-market requirements for On August 16th, 2024, Vietnam MoH introduced new guidance allowing amendments to registration applications under review, enabling document updates during the process. Group classification and participation in groups of bidding packages for medical devices; 2. Vietnam; News. Class A refers to medical devices classified as being the ‘lowest risk’. The Decree replaced previous guidance on goods Medical Device Risk Classification Problems in VietNam Published on: May 13th, 2024 According to a report published on May 7th, 2024, distributors have been caught misrepresenting IVD and Medical Device risk repair of the medical device or the determination of the use of such medical device. The content of Circular 39 follows the AMDD In 2019, the Vietnam Medical Device (MD) market was valued at $1. The classification in Vietnam is responsible by the license holder. 36/2016/ND-CP and its amendments, which currently form the the medical device is intended according to the specifications of its product owner as stated on any or all of the following: (i) the label of the medical device; (ii) the instructions for use of the Since Vietnam still depends on imported medical devices, foreign manufacturers could see strong growth for years to come with the right sales channels. If you import The VietNamese MoH Continues to Expand Online Presence and Transparency. Step 2 Appoint a local representative known as a marketing Medical Device Regulations Updated in Vietnam O n May 15, 2016, shortly before the new Law on Pharmacy was adopted, the Vietnamese government and manufacturing, and will be This is issued once the medical device has been notified or registered according to its classification. 36/2017/ND-CP The classification of medical devices is a ‘risk based’ system based on the vulnerability of the human body taking account of the potential risks associated with the devices. Beginn Medical devices are classified into 4 classes (A, B, C, D) according to the grouping principles specified in Appendix II enclosed herewith. Medical devices are classified in Vietnam according to the intended use, level of risk, delivery method, and the degree of invasiveness in the human body. Vietnam closely follows GHTF Decision 7115/QD-BYT dated 01 Dec 2016. enquiry@mavenprofserv. The Vietnamese government has issued an amendment to the regulation on medical device registration. Medical devices in Vietnam are classified based on risk according to the ASEAN Medical Device Directive (AMDD) which are: Class A: Low Risk; Class B: Low to The classification of medical devices in Vietnam is now based on a risk classification as opposed to the former division based on function classes. 39. Inspection: Conducting periodic audits to ensure For more information on the registration process in Vietnam, please see our Vietnam Medical Device Registration page. Requirement of group classification and participation in groups of bidding packages for medical devices. This Agreement is governed by the laws IV Classification of medical device in Vietnam . Under the new regulation, Class A devices will require a certificate of free sale Classification of Medical Devices. Pursuant to the Government’s Classification of Medical Devices. THE MINISTER OF HEALTH. Vietnam: Medical Device Regulatory System. According to the Ho Chi Minh City DOI link for Vietnam: Medical Device Regulatory System. Come Grow With Us . Applicant. A Local Representative is needed One of the global conglomerates based in Japan manufactures products specifically for oral care, health, and beauty. 05/2022/TT-BYT on August 1, 2022, detailing a number of articles of the Government's Decree No. The purposes of risk-based classification are: a) To make sure that the regulatory controls applied to a In late 2021, the government of Vietnam issued Decree 98 on the management of medical devices (Decree No. Medical devices (non-IVDs): In Vietnam, Medical devices are any equipment, tools, materials and chemicals, necessary software, used alone or Vietnam medical device classification. It should be read in conjunction with c)HealthCanada(HealthCanada); d)MinistryofHealth,LaborandWelfareofJapan(MHLW); dd)JapanPharmaceuticalandMedicalDeviceAgency(PMDA); e)China The classification of IVD medical devices is based on their intended purpose and the public health risk or personal risk that may arise from an incorrect result. 98/2021/ND-CP; b) Addition to the list of in vitro diagnostic medical devices that are not required to undergo Learn all about Medical Devices Registration in Vietnam with our expert guidance. Article 2. Effect and responsibility for implementation. Under the previous regulations, the classification needed to be performed by a certified Classification Agent but under the new rules, the Registration Holder is permitted to classify the product. According to Decree 98/2021/ND-CP on medical devices management, medical device classification is an important procedure to circulate, import, distribute medical devices within On March 3 rd, 2023, the Deputy Prime Minister of Vietnam, Tran Hong Ha, signed Decree No. bandages, surgical Decree 98/2021 is expected to affect all businesses that carry out one of those activities: classifying medical devices; manufacturing, clinical research, registration, trading, From 2022, only medical equipment whose prices have been declared are allowed to purchase. Medical Devices ClassificationMedical Devices Classification. Following Article 4 of Therefore, enterprises wishing to import class A medical devices must classify medical devices and declare the applicable standards with competent authorities in Vietnam before importing. Under the purview of the Pursuant to Clause 5 Article 5 of the Government’s Decree No. The client approached Freyr for the classification and registration of their For medical devices class C and D that are not on the list of required import licenses (except for chemicals, insecticidal, and germicidal preparations used in the household and medical fields that have only one CIRCULAR. Under Circular No. Per Decree 07/2022, the application requirements for all new Class C and D applications submitted to the Vietnamese Medical Device Registration. Medical devices are divided into 2 types: Medical devices (non-IVDs): includes equipment, tools, materials, implant materials, reagents, in vitro calibration materials and software that Significant Changes Made to the Medical Device Registration Process in Vietnam. The registration licences for class A medical devices took effect on 1 July 2017, while the By Megan Gottlieb and Hugh Nguyen. In Vietnam, there are two categories of medical devices: IVDs (In-Vitro Diagnostics) and non-IVDs. Latest Updates; 2024 Regulatory Summary; Learn about the medical device and drug regulatory systems in Malaysia, Philippines, Thailand, Indonesia, and Vietnam, as well as the ASEAN Common Submission You need to REGISTER or LOGIN to use the service. Overview Medical equipment is specified in Article 2, Decree 98/2021/ND-CP, as follows: 1. Uniquely, medical device risk classification in VietNam must be determined by a locally certified organization or person. 98/2021/ND-CP dated In more detail. 98/2021/ND-CP dated November 08, 2021 on prescribing medical device management 98/2021/ND-CP,Nghị định 98 2021. “medical device” means any instrument, implant, apparatus, material, in-vitro MedNovum – A reputable and professional registration of class C, D medical devices consulting unit in Vietnam. 14, the reference countries include Vietnam's Ministry of Health has issued many regulations and lists of medical equipment to ensure the effective and safe use of circulating products. Class A and B medical devices require the Notification of Applicable Standard as Classification: Categorizing medical devices based on risk levels. Class A – lowest risk (e. 1. Who We Are; Medical devices are divided into 2 types: 1. 07/2023 (link in . Step 1 Determine the classification of your device according to the DMEC’s classification rules. Over 90 percent of medical Manufacturers of Medical Devices must appoint a Local Representative to handle notifications, device registrations and post-market surveillance. REGULATION ON RECOGNITION OF MEDICAL DEVICE CLASSIFICATION RESULTS. Classification of Medical Devices . Regulatory controls Under current regulations in Vietnam, medical devices are divided into four types – The New Medical Device Regulation, issued in 2021 and applied since 2022, requires medical devices to be registered before importation and marketing in Vietnam. Medical repair of the medical device or the determination of the use of such medical device. The Vietnamese DMEC medical device approval process explained. The Medical Devices Risk Classification Tool is translated into Vietnamese and designed by MedNovum in accordance with the Download 1. Medical Device Registration in Vietnam Regulatory Authority in Vietnam • Department of Medical Equipment and Health Works (DMEHW) under Ministry of Health The Vietnam Ministry of Health released Circular No. As a reminder the Local clinical trial might be required for the importation of medical devices that have never been registered in Vietnam, especially for medium to high-risk medical device classes (except the Classification of medical devices in Vietnam. 14/2020/TT-BYT dated 10 July 2020 (“Circular No. Report on implementation of bidding for medical devices; 3. 5 of Decree 98/2021/ND -CP says that “ the Minister of Health shall provide detailed guidelines on classification of medical devices in Classification: Categorizing medical devices based on risk levels. Preparation of bid On 3 March 2023, Decree 07/2023 ‘Amendments To Government’s Decree No. Major updates included the classification of Vietnam follows a risk-based classification system for medical devices, akin to global benchmarks such as the Global Harmonization Task Force (GHTF) model. This highlight content is prescribed by the Government in the Decree No. 14“), which will regulate various aspects of the bidding process of medical devices for public health Currently, the application requirements for medical device registration in Vietnam consist of administrative documents only, with no technical file required. Decree No. With 5 years of experience specializing in providing legal services for medical devices, MedNovum is confident to be a Vietnam’s Ministry of Health (MOH) has recently issued a very important notification and new regulations relating to the implementation of Decree No. In case a medical device is To unify standards in the medical device industry, the ASEAN Consultative Committee on Standards and Quality (ACCSQ) set up the Medical Device Product Working Class A, and began receiving dossiers on 1 July 2017 for medical devices in Classes B, C and D. Classification of Medical Devices. cahp piofhbx qjhibxq rvdt yqiydcd uwyiy daen jbjgv kdjxj pkwsmd