Overview Vietnam’s Medical Device market is picking up over the years and is currently one of the booming sectors in the country. Medical Devices in the country are regulated by Department of Medical Equipment and Health Works (DMEHW) under Ministry of Health. 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). Appointment of reliable and capable Vietnamese agent for foreign manufacturers is crucial as they must undertake the warranty services offered by manufacturer as part of the device sale. Translation to Vietnamese is a must to enter the region, which indeed can be challenging in actual practice. Freyr offers Regulatory support extending the complete range of activities such as procuring Free-sale Recognition Number involved in medical device approval from authorities. We also provide linguistic expert support to maintain the Regulatory perspective of the translation intact. We cater to the post-approval needs of clients to maintain compliance throughout product lifecycle in Vietnam. Vietnam Market Entry for Medical Devices - Process Flow Freyr Expertise Regulatory Assistance in Registration Process Medical Device Classification Support in Free-sale Registration Number (FRN) Procurement Local Authorized Representation Summary S.No Regulatory Parameter Vietnam 1 Regulatory Authority Department of Medical Equipment and Health Works (DMEHW) 2 Regulation Decree 36/2016/NĐ-CP (Medical Equipment Management) 3 Risk Classification Type A - Group 1 Type B - Group 2 Type C - Group 2 Type D - Group 2 4 Regulatory Pathway Type A Declaration of applicable standard Type B, C & D Certificate of free-sale registration 5 Authorized Representative Required 6 Fee payable ~ $ 200* 7 QMS Requirement ISO 13485 8 Assessment of Technical Data Department of Medical Equipment and Construction (DMEC) of MoH 9 Validity of License Type A Unlimited Type B, C & D 5 Years 10 Labelling Requirements Article 54 of Decree 36/2016/NĐ-CP 11 Submission format Online 12 Final Outcome Free-sale registration number 13 Timelines 15 - 60 days 14 Language English & Vietnamese *The price is as per records at the time of documentation and is subject to change.