New Labeling Requirements In Vietnam

In February, Vietnam issued new labeling requirements for goods including medical devices via Decree 111.

Medical device labels in Vietnam must include both the owner (name and address) and the owner of the registration number (name and address). If the device does not have a registration number, the company or person on the import license will need to be visible too. If the label is in English or another foreign language, a Vietnamese label must be added. Generally, the labels should also include where the product is from, the responsible entity, and product name.

If the medical device has been in Vietnam before Decree 111 was issued, old labeling requirements are ok until the product’s expiration date.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

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