Vietnam issues new regulation for product labeling
On 9 December 2021, the Vietnam government released Decree No. 111/2021/ND-CP which amended Decree No. 43/2017/NĐ-CP on product labeling regulation, including medical devices. This decree will come into effect on 15 February 2022.
According to this new decree, organizations and individuals producing, exporting, and importing goods must determine and label the origin of goods, as well as ensure the truthfulness, accuracy, and compliance with legal provisions on the origin of exported, imported, or manufactured goods in Vietnam, or international agreements to which Vietnam is committed.
In situations where the origin of goods cannot easily be determined, the place of final stage of finishing the goods is performed shall be used on the label. It shall be expressed by one of the following phrases or a combination of phrases expressing the finishing stage of goods as follows: “assembled at”; “bottled at”; “mixed at”; “completed at”; “packed at”; “labeled at” with the name of the country or territory where the final stage of finishing the goods is performed.
This new decree also amends and supplements Article 12 of Clause 3 of Decree No. 43/2017/ND-CP concerning the name and address of the organization or individual responsible for the goods. 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 (i.e. the legal manufacturer), and
- the name and address of the owner of the registration number (i.e. the company or individual who is the registrant).
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.
Medical device labeling in Vietnam: language requirements
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.
This supplementary label is added after customs clearance procedures are carried out and before the goods circulate in the Vietnamese market.
Medical device relabeling services in Vietnam
As part of our registration and importation services of medical devices into Vietnam, we also offer relabeling services for medical devices entering the Vietnamese market.
If you have any queries regarding registrations, market authorizations or our services for medical device registration, representation, importation or relabeling in Vietnam, please click on the button below.
To learn more about registering medical devices in Vietnam click here.
To learn more about the medical device market in Vietnam click here.