On October 4th, 2021, Vietnam Minister approved the plan to reduce and simplify regulation related to business activities under the management of the Ministry of Health. More than 100 administrative procedures are included. One is to convert Import Permit number to Registration number and to amend requirement on application for fast approval from 2 CFS to 1 CFS. Likewise, procedure for declaring eligibility to trade medical devices class B, C, D and procedure for issuing certificate of advertising contents on medical devices are abolished.
In particular, for medical devices that has been granted an Import Permit under Circular 30/2015, License Holder shall create an application in compliance with Decree 36/2016 and ensure this registration submission dossier is identical with import permit file. All issued Import Permit, Letter of Authorization, CFS and ISO13485 must be valid at the time. Qualifying applications will be reviewed in 5 working days.
Next to this alteration, MOH shall amend the requirement for fast approval from 2 CFS to 1 CFS. Current regulation requires medical device to be circulated in at least 2 reference countries including Japan, Canada, Australia, America and EU countries. In addition, MOH shall allow applicant to change from regular registration route to expedited without having to submit a new application. This option will reduce costs for businesses and shorten the reviewing process for MOH.
Implementation roadmap for this procedure is from 2021 to 2022, same as roadmap for abolishing procedure for declaring eligibility to trade medical devices class B, C, D. It is from 2022 to 2025 in case of abolishing procedure for issuing certificate of advertising contents on medical devices.