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

On March 1, 2021, the government of Vietnam promulgated Decree No. 14/2021/ND-CP on Penalties for Administrative Violations Involving Animal Husbandry (Decree 14). The new decree took effect on April 20 and, among other contents, repeals the regulations on animal feed found in Decree No. 64/2018/ND-CP dated May 7, 2018. In the field of animal feed, notable penalties of Decree 14 include the following: Penalty forms and levels For each administrative violation, the violator will be imposed a monetary penalty, which is the main penalty form. For the same violation, the monetary penalty level applied to an organization is double the amount applied to an individual. In addition, based on the nature and extent of the violation, additional penalties may be imposed on the violators, including confiscation of violating items, and confiscating Certificates of Eligibility to manufacture animal feeds. Violations of regulations on declaring product information A fine of up to VND 3 million (USD 130) will be imposed for the act of changing information on product labels that has been published on the Portal of the Ministry of Agriculture and Rural Development (MARD) without conducting the notification procedure to inform the MARD of such change. A fine of up to VND 7 million (USD 300) will be imposed for the act of deliberately falsifying or erasing contents of documents or making false declarations in the applications for animal feed products on the Portal of the MARD. Violation of regulations on quality in importing animal feed A fine of up to VND 25 million (USD 1,080) will be imposed for the act of importing each animal feed having (i) a quantitative content of each quality criterion lower than the minimum level or higher than the maximum level compared with the standards announced or written on the goods label; or (ii) each safety criterion/each harmful microbiological criterion exceeding the allowable threshold under technical regulations or applied standards, depending on the specific criterion and percentage difference. Violation of regulations on purchasing, selling, and importing expired animal feed A fine of up to VND 40 million (USD 1,730) depending on the value of the violating goods will be imposed for the act of purchasing, selling, or importing animal feed products whose labels or enclosed documents state that the product has expired. A fine of up to VND 10 million (USD 430) will be imposed for the act of not presenting or incorrectly presenting the manufacturing date on the product label or documents accompanying the product. Violations of regulations on purchasing, selling, and importing animal feeds containing antibiotics A fine of up to VND 15 million (USD 650) will be imposed for each acts of purchasing, selling, or importing an animal feed product having antibiotic content different from the content presented on the product label or in the documents accompanying the product, depending on the difference. A fine of up to VND 15 million (USD 650) will be imposed for each act of (i) purchasing or importing an animal feed product containing antibiotics in which the information about the name and content of antibiotics, instruction for use, or time to ease using is not presented on the product labels or accompanying documents; or (ii) importing an animal feed product containing antibiotics without a prescription or not according to the prescription of a person having a practice certificate of prevention and treatment of animal diseases. A fine of up to VND 20 million (USD 860) will be imposed for the each act of (i) importing an animal feed product containing antibiotics that is not a complete mixed feed for livestock or poultry, or pure feed for grass-fed cattle; (ii) purchasing, selling, or importing an animal feed product containing antibiotics to prevent disease for pets that are not in the immature stage; and (iii) purchasing, selling, or importing an animal feed product containing antibiotics for the purpose of growth stimulation. A fine of up to VND 30 million (USD 1,300) will be imposed for the acts of purchasing, selling, or importing each animal feed product containing antibiotics that is not a veterinary drug approved for circulation in Vietnam or has not been approved by the relevant authority. Violations of regulations on using animal feed material A fine of up to VND 20 million (USD 860) will be imposed for each act of using an animal feed material which is not listed in the list of materials permitted to use in animal feed, depending on the value of the violating batch or the amount of illicit profits. Remedial measures In addition to the fines above, some remedial measures below are applied, depending on the case: Being forced to repeal the published animal feed product information, or correct the false information published on the Portal of the MARD; Being forced to recall, recycle, transform the use purpose, re-export or destroy the violating products; and Being forced to re-submit the illicit profits gained from the violations. Transitional provisions For administrative violations that occurred before the effective date of Decree 14 (April 20, 2021) but were detected later, or are being considered and resolved, regulations that are beneficial to the violators will be applied. For decisions on sanctioning of administrative violations that were issued or completely implemented before the effective date of Decree 14, but for which the violators can still appeal the decision, the previous legal document (Decree No. 64/2018/ND-CP) is applied. For violations detected after the effective date of Decree 14 that are effective in transitional provisions in the Law on Animal Husbandry and documents detailing the implementation of the Law on Animal Husbandry, Decree No. 64/2018/ND-CP is still applied until the transition period expires.

In an effort to unify and streamline regulations on the management of medical devices in Vietnam, the Ministry of Health (MOH) recently developed the draft of a new decree intended to replace the existing legislation.

Practitioners from Tilleke & Gibbins’ Hanoi and Ho Chi Minh City offices contributed content for Vietnam to the latest edition of the Practical Law Life Sciences Global Guide.