Introduction

The client recently established a manufacturing site in Vietnam to manufacture whole blood collection sets and apheresis disposable sets. The products were intended for sale in Vietnam and for export to other countries and had been approved by both the US FDA and had CE Mark.

Business Challenge

Despite having a local team in Vietnam and meeting with the local Ministry of Health, the client did not have clarity on how to obtain Certificate of Free Sales (CFS) and how to legalize the CFS.

Solution

Through RegDesk’s expert-sourced regulatory intelligence service, the client was able to receive a step-by-step process of how to obtain and legalize the CFS. In the process, the client also gained knowledge and insights of how to register their product in Vietnam.

Results

The client verified the information received through RegDesk with the information they had obtained through their consultation with the local Ministry of Health and determined the knowledge received through the local experts was accurate and superior to what they had received from the Ministry of Health.

Why RegDesk

RegDesk is an A.I.-powered regulatory intelligence software that offers 24/7 access to the latest regulatory information for over 50 markets worldwide. Our platform eliminates the need for medical device companies to spend months gathering intelligence and preparing their registration applications. Through RegDesk’s centralized platform, clients can get access to product-specific registration requirements, expert answers to their most critical regulatory questions, and real-time alerts about global regulatory changes. To experience the power of RegDesk, contact us at desk@regdesk.co or visit www.regdesk.co.