Intellectual property experts from Tilleke & Gibbins were engaged by ARISE+ IPR, a regional support program funded by the European Union and implemented by the European Intellectual Property Office, to craft a series of IP enforcement guides for Southeast Asian countries, aimed at raising local awareness of the importance of IP protection. The five-year, EUR 5.5 million ARISE+ IPR program supports regional integration through IP cooperation and aims to upgrade national IP systems for creation, protection, utilization, administration, and enforcement to be in line with international best practices and standards and the strategic objectives of the ASEAN Intellectual Property Rights Action Plan 2016-2025. The guides were developed by Tilleke & Gibbins’ lawyers in cooperation with the IP offices of each participating country, and cover issues related to trademarks, industrial designs, and geographical indications. Each guide was produced in a compact leaflet form in English as well as the local language, and is considered an official publication of the respective national IP office. The guides can be accessed from the ARISE+ IPR site (under “Leaflets, brochures and booklets”), or by clicking on the links below: Cambodia: English | Khmer Indonesia: English | Bahasa Indonesia Thailand: English | Thai Vietnam: English | Vietnamese

On December 9, 2021, the Government of Vietnam issued Decree No. 111/2021/ND-CP amending and supplementing Decree No. 43/2017/ND-CP dated April 14, 2017, on goods labeling (Decree 43). Decree No. 111/2021/ND-CP (Decree 111) takes effect on February 15, 2022. Under Decree 111, the regulations on goods labeling will change as follows: Exported goods The scope of regulations for goods labeling is currently restricted to goods imported and circulated in Vietnam according to Article 1.1 of Decree 43. However, under Decree 111, the scope is expanded to include exported goods, and exporters are added to the list of entities subject to the regulations. An exception is added whereby exported goods do not need to be labeled in Vietnamese if the goods are not consumed domestically. According to the new regulations, labels for exported goods must comply with the regulations of the import country. The origin of goods must be identified and labeled in compliance with Vietnam’s laws on origin of goods or with international agreements Vietnam has joined or signed. Moreover, the label must not display any images or information relating to a sovereignty dispute or other sensitive information which may affect national security, politics, the economy, society, diplomatic relations, or traditions of Vietnam. Origin of goods Under Decree 43, it is compulsory to display the origin of goods on their labels with no alternatives. This can cause difficulty for entities who cannot determine the origin of the goods. Decree 111 has addressed this issue by adding a clause whereby, if the origin of goods cannot be determined, it is required to clearly state the place where the final production stage is conducted to complete the product. The following statements should be used to present the final production stage: “assembled at”, “bottled at”, “mixed at”, “finished at”, “packed at”, or “labeled at”, followed by the country name or the territory where the final completion process takes place. Compulsory information on original labels Decree 43 mentions the original label as the initial label attached to a good or the good’s commercial package by the manufacturer. If the original label of an imported good does not conform with the provisions of Decree 43, the importer must make supplementary labels with the compulsory contents before putting such goods into circulation together with their original labels. This means there is no compulsory information for original labels. However, Decree 111 requires that goods imported into Vietnam must have original labels that fully display certain compulsory information. Electronic presentation of information According to Decree 111, several contents can be presented electronically. The Minister of Science and Technology will promulgate guidance on electronic goods labeling. Presentation of food ingredients For food ingredients, unlike Decree 43, Decree 111 allows the INS to be used instead of a specific name when presenting the names of sweeteners or colorings in the ingredient list section, while it is no longer required to specify the names of flavorings in this section. Transitional provisions After the new decree takes effect on February 15, 2022, goods with labels in compliance with Decree 43 that were manufactured, imported, and/or circulated before the effective date can continue to be circulated and consumed until their expiry date. Goods labels and packages with accompanying labels in compliance with Decree 43 that were manufactured or printed before the effective date can also continue to be used for manufactured goods, but for no more than two years beyond the effective date (i.e., not after February 15, 2024).

On November 8, 2021, the Vietnamese government issued Decree No. 98/2021/ND-CP on the Management of Medical Devices (“Decree 98”). The new decree will take effect from January 1, 2022, replacing Decree No. 36/2016/ND-CP and its amendments on the same subject (“Decree 36”). Below are the main highlights of Decree 98: 1. Classification of Medical Devices Under Decree 98, responsibility for the classification of medical devices is given to the organization registering or declaring the medical device. Under Decree 36, this responsibility was reserved for Vietnamese organizations qualified for medical device classification. 2. Clinical Trials of Medical Devices Decree 98 provides stricter and more detailed requirements on clinical trials. Particularly, medical device trials will include three phases, in which phases 1 and 2 need to be finished before the product registration, while phase 3 will be conducted after the medical devices are approved for circulation, following the specific requirement from the authorities. This requirement aims to continue evaluating the safety and efficacy of medical devices after they are widely used in the community in line with their usage conditions. 3. Medical Device Registration Similar to the current regulations, Decree 98 requires that medical devices must be registered with the Vietnamese authority (i.e., must obtain registration numbers) before being imported/manufactured for circulation in the Vietnam market. However, Decree 98 further stipulates new requirements as below. Validity of registration numbers Under Decree 98, the registration numbers for all classes of medical devices, not only Class A medical devices as in the current regulations, are valid indefinitely, except for registration numbers granted under the emergency registration procedure. Registration procedure for Class A/B medical devices Instead of having to register with the central level authority with a complex registration dossier as currently required, Decree 98 allows Class B medical devices to be subject to a simpler registration procedure, namely, “Declaration of applied standard” with the provincial level authority, which is the same procedure as for the lowest risk Class A devices. Registration procedure for Class C/D medical devices For the first time in Vietnam, Decree 98 sets out three procedures to apply for registration of Class C/D medical devices: the normal registration procedure, a quick registration procedure, and an emergency registration procedure. The Ministry of Health’s evaluation timeline for handling registration dossiers for Class C/D medical devices under the normal procedure will be up to 45 days, while the timeline under the quick and emergency procedures will be only 10 days. Quick registration procedure: Class C/D medical devices that are subject to the quick registration procedure will include: Products granted a Certificate of Free Sale (CFS) or marketing authorization (MA) by at least one of the following organizations/countries: the United States Food and Drug Administration; the Therapeutic Goods Administration of Australia; Health Canada; the Ministry of Health, Labor and Welfare or Pharmaceuticals and Medical Devices Agency of Japan; an EU-member country, the U.K., or Switzerland; the National Medical Products Administration of China; the Ministry of Food & Drug Safety of South Korea; or any organization included in the list of MA-issuing organizations recognized by the Vietnam authority (“reference countries”). Products granted import licenses or registration/MA numbers for commercial purposes in Vietnam Emergency registration procedure: This procedure is applicable to Class C/D medical devices used for epidemic prevention and control and overcoming consequences of natural disasters and catastrophes that are included in the list stipulated by the Minister of Health and fall into one of the following: Products approved for circulation or emergency use by one of the reference countries; Products included in the WHO’s list of products permitted for emergency use; Products included in the list of popular products declared by the EU Health Security Committee; Products granted import licenses or registration/MA numbers for commercial purposes in Vietnam; or Products produced in the form of technology transfer or processing of the above products. 4. Price Management In an effort to control the price of medical devices, Decree 98 includes a new requirement in which registration number holders must declare the prices of their medical devices on the Portal of Medical Device Management before putting the medical devices on the Vietnam market; the actual prices must not be higher than the declared prices. The authorities may question the registration number holder about grounds for the declared prices at any convenient time. 5. Importation of Medical Devices Decree 98 sets out situations where medical devices without registration numbers must have import licenses. These include, among others, medical devices for scientific research, tests, trials, quality assessment, or training; medical devices for aid, humanitarian aid, gifts, fairs, exhibitions, displays, or product introduction; and medical devices meeting urgent needs for national defense, security, epidemic prevention and control, and overcoming consequences of natural disasters and catastrophes. 6. Medical Device Advertisement Decree 98 completely removes the procedure for approval of medical device advertising contents. Instead, the holders of medical device registration numbers or their authorized entities will be responsible for publicly declaring the intended content and form of the advertising on the Portal of Medical Device Management before conducting the advertising. 7. Transitional Regulations Decree 98 sets out the following transitional mechanisms: Medical devices produced/imported into Vietnam before January 1, 2022, may be continuously circulated until they are liquidated as stipulated or until their expiry date. For import licenses/registration numbers granted before January 1, 2022: Registration numbers granted under Decree 36 and its amendments will be valid indefinitely. MAs granted to domestic medical devices will be valid until their expiry date. Import licenses for medical devices that were granted from January 1, 2018, will be valid until December 31, 2022. Import licenses for medical devices that are IVD biologicals will have no limit on quantity. For Class C/D medical devices that are not subject to import licenses and whose classification results were published on the Portal of Medical Device Management, they can be continuously imported until December 31, 2022, with no limit on quantity and without an approval letter from the Ministry of Health. MAs for medical devices that are IVD

Attorneys from Tilleke & Gibbins in Vietnam have written the Vietnam chapter of the newly released Fashion Law 2021, a guide to law surrounding the business of fashion in jurisdictions around the world. The guide covers 18 key jurisdictions for the global fashion industry, offering insights into local legal frameworks surrounding vital issues such as brand enforcement and protection, e-commerce and marketing, and sustainability considerations. The Vietnam chapter of Fashion Law 2021 provides detailed information on the following topics: Trademarks, designs, copyright, and other intellectual property types such as patents and trade secrets. Strategic local contractual arrangements for manufacturing, distributing, and advertising fashion products. Overview and application of online marketing regulations and consumer protection regulations in Vietnam. The most relevant unfair competition rules for fashion businesses, and local courts’ interpretation and enforcement of the rules. ESG (environmental, social, and governance) concerns and sustainability issues for the fashion industry. Customs monitoring and local import and export guards against counterfeit products. The full Vietnam chapter is available for free on the Global Legal Post website. Tilleke & Gibbins also contributed the Thailand chapter to the guide.