Since 2016, the government of Vietnam has issued a number of legal documents on medical device management, including Decree No. 36/2016/ND-CP dated May 15, 2016; Decree No. 169/ND-CP dated December 31, 2018; and Decree No. 03/2020/ND-CP dated January 1, 2020; all of which are concurrently valid. 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 three decrees above. The draft is expected to be submitted to the government for further opinion and approval in the near future.
Below are some highlights of the new draft:
1. Clinical Trials of Medical Devices
The draft adds new regulations on clinical trials of medical devices. In particular, medical device trials will include three phases, in which phases 1 and 2 need to be finished before product registration while phase 3 will be conducted after the medical devices are approved for circulation following the specific requirement from the authorities. This regulation 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.
The draft also specifically stipulates cases (i) requiring full-stage clinical trials, (ii) being exempted from some stages of clinical trials, and (iii) being entirely exempted from clinical trials. The full exemption is intended to be applicable to class-A medical devices and medical devices that are already approved for circulation in at least one country in the world, and have sufficient safety and efficacy data.
Also, the draft sets out provisions on the requirements and obligations of relevant entities (the owners of the medical devices that need to be clinically evaluated and entities conducting the trials); dossiers for the trial; and procedures and processes to register and approve clinical trial protocols and trial results.
2. Medical Device Circulation
The draft adds two additional cases ((c) and (d) below) that qualify for the quick registration procedure. Accordingly, under the draft, the class-B/C/D medical devices that are subject to the quick registration procedure will include:
- Products circulated in at least two of the following countries: Japan, Canada, Australia, the U.S., an EU member country, the U.K., or Switzerland.
- Products circulated in Vietnam prior to December 31, 2020, and satisfying both of the following conditions:
- The product was circulated for at least three years within a period of five years before the submission date.
- There have been no warnings about the quality or safety of the product.
- Products granted an import license and circulated in at least two countries in the world, one of which is Japan, Canada, Australia, the U.S., an EU member country, the U.K., or Switzerland.
- Products meeting urgent needs for national defense, security, epidemic prevention and control, and overcoming of consequences of natural disasters and catastrophes, and having no substitutes available on the market.
Further, according to the draft, the MOH’s evaluation timeline will increase – up to 120 days instead of up to 60 days under current regulations. This is to ensure the feasibility of the evaluation.
3. Importation of Ingredients for Medical Device Production
Under the draft, import licenses are not required for medical device raw materials, except for materials containing narcotic substances and precursors.
4. Medical Device Advertisement
Under the draft, the content of medical device advertising must conform with either the dossiers for declaration of applicable standards for class-A medical devices, or the registration dossiers for class-B/C/D medical devices.
In addition, advertising contents will not require approval from the authorities. 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 Medical Equipment Management Portal before conducting the advertising; the declaration for class-A/B medical devices would be applied from July 1, 2021 while the declaration for class-C/D medical devices would be applied from July 1, 2022.
5. Transitional Regulations
The draft sets out the transition mechanisms below:
- Import licenses for class-B/C/D medical devices granted from 2018 to 2022 will be valid until December 31, 2022.
- The procedures for obtaining import licenses during the transition period for class-B/C/D IVD medical devices, including reagents, calibrators, and control materials, are newly stipulated; this also means that the current procedures under Circular 47/2010/TT-BYT guiding the export and import of medicines and packaging in direct contact with medicines and Circular 30/2015/TT-BYT on import of medical equipment will be abolished.