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

Indonesia’s National Agency of Drug and Food Control (BPOM) has issued a regulation to amend the country’s food labeling regulations by instituting various additional restrictions and providing additional clarity on food labeling requirements—not only for final food products but also for food additives and food products for further processing. The additions are contained in Regulation No. 20 of 2021 (an amendment to Regulation No. 31 of 2018), which took effect on August 2, 2021. The deadline to comply with the new labeling requirements for final food products is December 31, 2021, and the deadline for requirements related to food additives and food products for further processing is August 2, 2022. The new requirements introduced by the latest regulation are outlined below. Final Food Products Non-halal foods. The new regulation clarifies that food products containing non-halal ingredients are exempt from halal certification requirements. This provision is important as it explicitly confirms that non-halal food products can still be sold and distributed in Indonesia. Ingredient percentages. Percentages of ingredient content must be included in the list of ingredients on a food label, and on any ingredients that are emphasized on the label in words or pictures, or stated as part of the food name. Polyol warning. Labels for food products containing polyol must now include a warning to this effect. Allergen information. The new regulation provides an alternative for indicating allergen information on the food label. Under the 2018 regulation, allergens had to be indicated in the ingredients list in bold type, and the label had to have the disclaimer “contains allergens, see list of ingredients printed in bold.” The new regulation, however, allows allergen information to be declared on the label with the phrase “contains allergens:” followed by the allergen name(s) printed in bold. With this new alternative, it is

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

Attorneys from Tilleke & Gibbins have provided the latest update to the Thailand contribution to Doing Business in…, a Q&A-style guide published by Thomson Reuters Practical Law that presents an overview of the legal framework for doing business in 63 jurisdictions worldwide. The Thailand chapter of the guide outlines Thailand’s legal system and key laws applicable to foreign companies doing business in the country. The chapter specifically covers the following main topics: Legal system: Thailand’s court system and codified legal system. Foreign investment: Lists of reserved business activities, restrictions on doing business with certain jurisdictions, exchange controls and currency regulations, and grants and incentives available to investors. Business vehicles: Ordinary partnerships, registered ordinary partnerships, limited partnerships, private limited companies, and public companies. Environment: Main laws and regulations, factory operation. Employment: Laws, employment contract requirements, work permits, and termination and redundancy. Tax: Taxes on employment, tax and nontax resident employees and businesses, corporate income tax, value added tax, special business tax, municipal tax, stamp duty, dividends, interest, intellectual property royalties. Competition: Important aspects of Thailand’s regulatory regime surrounding competition, centered around the updated Trade Competition Act. Antibribery and corruption: Laws, compliance requirements, regulatory authority. Intellectual property: Patents, trademarks, registered and unregistered designs, and copyright. Marketing agreements and advertising: Regulation of marketing agreements, Thailand’s Consumer Protection Act, direct marketing, role of the Consumer Protection Board and Food and Drug Administration. E-commerce: E-commerce laws and regulations, marketing and sales via online platforms. Data protection: An outline of Thailand’s Personal Data Protection Act. Product liability: Procedures and regulations for product liability and product safety, including the Unsafe Goods Liability Act and the Consumer Case Procedure Act. Product liability: Key regulatory authorities for trade competition, environmental issues, and financial services. To browse, download, or print the Thailand chapter, please visit the Practical Law website.