License maintenance is an important consideration for manufacturers selling medical devices in Vietnam as failures to comply could lead to importation delays or loss of market access. Unlike in the U.S. and Europe, where many changes made to a registered medical device or its production process can be updated retroactively in the technical documentation, in Vietnam changes made to a medical device will typically require an amendment to the license before the updated device can be imported into the country, and possibility a new registration application. So, it is important to understand when a medical device registration amendment is required in Vietnam to avoid Customs clearance delays and maintain timely market access.
Changes made to a registered medical device that require an amendment:
Address of product owner, or license holder
Name of the license holder
Either name or address (no both) of the product manufacturer
Product packaging (for IVDs)
Labels and instructions for use, but the indication of the product cannot be changed
The notification of the change should include a notification letter and relevant documents to the change. License Maintenance compliance in this way is compulsory to clear customs and sell devices in Vietnam.
Notice: Changes – Interpretations of permissible modifications can vary and it’s important to always check with your License Holder or Regulatory Professionals when considering new changes to maintain compliance and avoid losing market access.
Contact Asia Actual with any medical device license amendment questions in Vietnam. Our local, bi-lingual regulatory experts are well positioned to assist.