Export medical devices to vietnam. In Vietnam, there have been adjustments to streamline the procedure, yet the process remains complex for foreign healthcare providers entering this dynamic market. 31/2022 Explore healthcare export opportunities and the regulatory environment in Vietnam. Introduction to Vietnam’s Medical Device Market Vietnam’s medical device market has experienced remarkable growth in recent years, driven by increasing healthcare expenditure, an aging population, and rising demand for advanced medical technologies. Medical devices classification. Vietnam Medical Import-Export Joint Stock Company operates as a diversified healthcare and trading company centered on pharmaceuticals and medical products. Medical device registration in Vietnam is a must to ensure that a device is compliant with essential safety and medical standards. In June 2017, in cooperation with Traide and German Ministry for Economic Affairs, BDG Vietnam Nov 30, 2020 · How to distribute medical goods in Vietnam Under the Law of Vietnam, only businesses registered in Vietnam with an import license will be able to distribute medical devices legally in Vietnam. Mar 25, 2025 · Step 3. Product registration certificate or equivalent document. Dec 26, 2023 · By leveraging DHL Express Vietnam's Medical Express (WMX) services, a specialised pharmaceutical and medical device shipping solution, businesses can seamlessly navigate the complexities of overseas shipping. Therefore, foreign medical device suppliers are required to set up a local office or appoint local distributors. In June 2017, in cooperation with Traide and German Ministry for Economic Affairs, BDG Vietnam About Exports In 2024, Vietnam exported $1. Apply for a medical devices import license Application for import license of medical devices into Vietnam: Application for import license. In addition, it provides advice to foreign suppliers with ambitions to enter Vietnam’s market. S. Foreign investors must first obtain an investment registration certificate (IRC) from the Department of Planning and Investment, followed by specific permits related to medical device manufacturing. Learn what's required, what's exempt, and how to secure market access in 2025. Vietnam Medical Device Industry: Facts, Figures and Opportunities This publication provides a comprehensive picture of Vietnam’s healthcare system, market and import regulations for medical devices. (Source: Australia Unlimited) In 2014, exports and imports of medical equipment reached US $ 751 million (up 127% from 2010) and US $ 707 million (up 44% from 2010). Most often, foreign medical device suppliers opt for selling their medical devices through Nov 25, 2024 · Establishing medical device manufacturing facilities in Vietnam requires careful navigation of various regulatory requirements and procedures. During the same year, Medical Instruments were the 47th most exported product (out of 1,176) in Vietnam. According to current regulations, all medical devices need to be classified. Only companies with a legal business entity registered in Vietnam and that have an import license are eligible to distribute medical equipment. Sales contract, commercial invoice, packing list. With the U. Medical devices are classified into 4 categories based on the level of potential risks associated with the technical design and manufacture of such medical devices: For foreign manufacturers, this framework clarifies what is needed to legally market medical devices in Vietnam and sets expectations for both administrative and technical compliance. Jul 17, 2025 · Vietnam now requires MA licenses for all medical devices. Mar 17, 2021 · Vietnam Briefing gives an overview of Vietnam’s medical devices industry and insights on emerging market trends as well as optimal market-entry paths. Bill of Lading. PrimeMed JSC is specialized in providing materials, equipment and devices for disease diagnosis and treatment; medical and patient education and training. . The organization imports and distributes drugs, vaccines, biologicals, medical devices, laboratory chemicals, and medical consumables. Economic growth and demographic changes are driving demand for healthcare services throughout Vietnam, and not just in the two economic centers of Hanoi and Ho Chi Minh City. However, medical devices are subject to regulation and licensing requirements set by MOH. Dec 1, 2024 · Export and Import of Medical Devices is not only a potential business sector but also a crucial part of the global healthcare system. market having a high demand for quality medical devices, Vietnamese enterprises need to understand the regulations, legal procedures, and quality requirements to successfully enter this market. Q&A: Vietnam’s Medical Devices Industry: Opportunities for European Businesses During the last decade, Vietnam has been experiencing rapid economic and population growth, making the country an attractive investment destination for foreign investors in the public healthcare sector. 73B of Medical Instruments, making it the 19th largest exporter of Medical Instruments (out of 222) in the world. These factors present significant opportunities for foreign investors but also come with regulatory challenges that require careful navigation. The Ministry of Health has issued Circular 19/2024/TT-BYT on October 1, 2024, to provide updated guidelines for exporting and importing medical devices. This circular introduces an official list of devices assigned Harmonized System (HS) commodity codes, aligned with the Vietnam Export and Import Goods Classification List (Circular No. Feb 14, 2020 · The major countries supplying medical equipment to Vietnam are Japan, USA, Singapore, China and Germany, accounting for 55% of Vietnam's medical equipment imports. zczjlj fsyuwh npx xpafpu lhzaltv imx zvawm zsqr qxewaz ghhrt