Vietnam Medical Device Labelling Requirementsngocthanh
Medical Device Management Stakeholders: – The Ministry of Health is responsible for the implementation of medical device legislation, strategies, policies and plans. Within the Ministry of Health, the Department of Medical Equipment and Construction (DMEC) oversees the issuance of import licenses, medical device registration numbers (classes B, C and D), certificates of free sale, and confirmation of advertising content. – The provincial Ministry of Health is responsible for the notification of Class A medical devices. – The Ministry of Science and Technology (MOST) has regulatory functions in the areas of product standards and quality and labelling. – The Ministry of Finance publishes regulations on the management and use of fees and charges related to medical devices. – The Ministry of Industry and Trade (MOIT) is responsible for regulating the import and export of goods. Regulation on Management of Medical Devices: On May 15, 2016, the Vietnamese Government issued Decree 36/2016/ND-CP, which regulates the management of medical devices, including the classification of medical devices; Production, labelling, transportation, supply, delivery, online reporting, registration, management and use of medical devices. Decree 36 regulates the management of medical devices and requires all medical devices imported into Vietnam to be registered for a marketing authorization (MA). In 2019, Vietnam`s medical device (MD) market was valued at $1.4 billion, making Vietnam the ninth largest market in the Asia-Pacific region. More than 90% of medical equipment and consumables are imported into the country. The sector is expected to grow at a compound growth rate of more than 10% per year over the next five years. – Type B, C and D medical devices include low- to medium-to-medium-, medium- to high-risk and high-risk medical devices. This new Decree also amends and supplements Article 12 of paragraph 3 of Decree No.
43/2017/ND-CP on the name and address of the organization or person responsible for the goods. In particular, for medical devices manufactured domestically or imported for distribution in Vietnam, labels must include: Contact us today for a consultation with our Vietnamese medical device consultants. Yes, all medical devices must be registered in Vietnam before they can be sold. Both imported and domestic equipment must obtain a Product Approval License (MA) before being sold in Vietnam. MA licences must replace all import licences after the import licence expires. To learn more about the medical device market in Vietnam, click here. Labels for medical devices in Vietnam must include both the owner (name and address) and the holder of the registration number (name and address). If the device does not have a registration number, the company or person must also be visible on the import permit. If the label is in English or another foreign language, a Vietnamese label must be added. In general, labels should also indicate where the product came from, the responsible organism and the name of the product.
Vietnam`s economy has developed rapidly in recent years and the medical device market is one of the many beneficiaries of this growth. About 70 percent of medical device purchases in Vietnam – measured in value – go to public hospitals. Due to easy access to the Vietnamese market and less regulation of imported equipment, there are huge opportunities for foreign companies looking to increase sales. A conformity assessment of quality systems is required for products of classes B, C and D and can be demonstrated with ISO 13485:2016. Asia Actual`s new tool for RP professionals, R.O.S.E., can help identify devices of the same type (also known as quality devices) and their classification. Click here to learn more. In Vietnam, medical devices are all necessary devices, tools, materials and chemicals, software used alone or in combination to prevent, investigate, diagnose and/or mitigate disease or to examine, replace, modify or offer surgical assistance during examinations and treatments. “As the new regulations for medical devices are in transition, it can be difficult to understand which requirements apply when. We can help. Decree No.
111/2021 – amends Decree No. 43/2017 and updates labelling requirements As part of our medical device registration and import services in Vietnam, we also provide relabeling services for medical devices entering the Vietnamese market. The devices are divided into 4 classes (A, B, C and D), which are also divided into two groups, group 1 (class A) and group 2 (class B, C and D). An official classification is available from the Vietnam Department of Medical Equipment and Health Works (DMEHW). The Ministry of Health has also updated the expedited review process for medical devices approved by at least 1 reference country, including the United States, Canada, Europe, Japan or Australia. As part of Resolution 98/2021, the Ministry of Health extended the approval of the acceptable reference country to China`s NMPA and Korea`s MFDS. Products benefiting from an authorisation of at least one of these markets will still have to submit the required documentation (technical summary, label, IFU, brochure before 31 December 2022, then CSDT), but will not be subject to a technical evaluation of the dossier, which aims to reduce the withdrawal time from 60 working days to 10 days. No, there are no requirements for country of origin approval. Approval by the reference country will significantly shorten the review time. The Vietnamese Ministry of Health is responsible for the implementation of legal documents, strategies, policies and plans related to medical devices.
Group 1/Class A devices must provide the statement of the applicable standard. Group 2/Class B, C, D will receive an over-the-counter registration certificate to market the products in Vietnam. In accordance with Article 62 of Decree 98/2021, which entered into force in July 2022, ALL promotional material (e.g. print, internet or video), including material aimed at direct consumers (DTCs) and health professionals, must be uploaded to the public portal. After downloading, a unique number is indicated, which must then be included in the advertising material when it is placed on the market. Under the new plan, ads can be removed from the market if they are found not to meet the requirements of the Ministry of Health. There is no charge for uploading material to the portal. How long are medical device approvals valid in Vietnam? If the medical device was in Vietnam before the issuance of E.O. 111, the old labeling requirements are acceptable until the product`s expiration date.
If the medical device does not have a registration number, the name and address of the company or person must appear on the import permit and the name and address of the owner of the medical device on the label.