MEDICAL DEVICE REGULATION IN VIETNAM
Medical devices are regulated by the Department of Medical Equipment and Construction (DMEC) from the Ministry of Health in Vietnam. Medical devices are regulated under different Circulars.
· For importing of medical devices by the Vietnamese traders and the importers, Circular No. 30/2015 for Non-IVD MD; Circular 47/2010 for IVD MD.
· For local manufactures medical device for circulation by Vietnam manufacturers or facilities, Decree 36/2016/NĐ-CP·
· For new regulation: Decree 36/2016/NĐ-CP
Some other general goods law also applies to the medical device.
MEDICAL DEVICE REGISTRATION AND APPROVAL IN VIETNAM
An import permit is required before the medical device is allowed to be imported into Vietnam if the imported device is on the list in Circular No. 30/2015/TT-BYT. The list of medical devices that requires an import license currently contains 49 product types. The list is subjected to a yearly revision if any, and any add-on to meet the practical status and suitability to the regulatory control on medical device importation.
Some new products also require an import license from the MOH although it is not on the list. ARQon is able to assess if the product requires an import license.
Under the new regulation: the documents to be submitted should be the same format found on the Vietnam application form. The format section is similar to the Executive summary of the ASEAN CSDT. However, this information must be in the Vietnamese language. In addition, there are other documents required to be prepared by the manufacturer.
ASEAN / Asia REP
Gaining product approval from local authority and market entry has been more and more challenging in the ASEAN market over the years with rapid increase in regulatory requirement and challenges encountered during the custom clearance.
Many companies have outsourced their regulatory to simply appointing Regulatory consultancy firm to handle all the challenging regulatory requirement and opens up more options for the companies in terms of license holding, ease of appointing various distributors and acting on behalf of the company to face the expectations from the local authorities. The choice of your local representative is equally important so it is important to understand what the service and network coming from your local representative.
ARQon is a certified ISO13485 company that has manufacturer’s license, importer license and wholesaler license in Singapore, comprise of diverse background technical experts, and vast network in the ASEAN region and globally.
Whether you are a local or foreign manufacturer, ARQon can assist to:
Be your local representative in the country.
Submit product registrations for all product classifications.
Set up the QMS & technical file for ISO13485, GDP and CE
Hold product license in the country.
Transfer product license to distributor (when manufacturer secure its preferred distributor in the country)
Appoint multiple importers and distributors.