Decree 111 introduces substantial modifications to Article 12 of Clause 3 of Decree43/2017/ND-CP concerning the name and address of the organization or individual responsible for the goods. That is, regarding the mandatory information to be embedded in the labels. Specifically, for medical devices produced domestically or imported for distribution in Vietnam, the labels must show the name and address of the owner of the medical device and the name and address of the owner of the registration number.
In situations where a medical device does not have a registration number, such as those listed in Appendix 1 of Circular 30/2015/TT-BYT requiring an Import License only, the name and address of the owner of the medical device, and the name and address of the organization or individual on the Import License shall be written on the label.
For medical devices imported into Vietnam whose label does not include or has insufficient mandatory information in Vietnamese, a supplementary label containing mandatory information in Vietnamese is required to be added, whilst the original label shall remain unchanged. The Vietnamese content shall be consistent with the original label text.
In accordance with Decree 111, if there is insufficient space on the packaging to include all the mandatory information on the label, then the following must be given priority:
● the name of the product,
● the name and address for the entity responsible for the medical device, and
● the origin of the product.
In addition, Decree 111 sets forth a labeling principle when the goods' origin cannot be identified. Particularly, the label shall present the place where the final processing step is undertaken. In this circumstance, the following phrases or a combination of the following phrases shall be presented together with the name of the country or territory where the mentioned final processing step is undertaken: 'assembled at', 'bottled at', 'mixed at', 'completed at', 'packed at', 'labeled at'.
Regarding transitional provisions, Decree 111 prescribes that goods with labels in accordance with the provisions of Decree No. 43/2017/ND-CP that have been manufactured, imported, or circulated in Vietnam before the effective date of Decree 111 are allowed to remain in circulation without any time limit, or until the expiration date, if any.
Decree111/2021/ND-CP amending and supplementing Decree No. 43/2017/ND-CP on goods labeling