Decree 98/2021/ND-CP on the management of medical devices
From 2022, only medical equipment whose prices have been declared are allowed to purchase
This highlight content is prescribed by the Government in the Decree No. 98/2021/ND-CP dated November 08, 2021, on the management of medical devices.
In accordance with the new provisions, to exempt from declaration of applicable standards and circulation registration for medical device is imported into Vietnam to serve the purposes of emergency aid or provision of humanitarian medical services; unregistered medical devices which are imported to serve pandemic prevention and control, or catastrophe and disaster relief and cannot be replaced by any other medical devices sold on the market.
Noticeable, it is required to post up the wholesale and retail prices of medical devices in VND at transaction or selling locations of medical device trading establishments; such prices shall be publicly posted on a board, paper or in other forms. Especially, it is not allowed to trade medical devices before the prices are declared or at prices higher than those available on the Ministry of Health’s portal on management of medical devices at the time of trading.
The Government also announces 11 online procedures related to medical equipment, including: Declaration of eligibility for manufacture of medical devices; Declaration of applicable standards for medical devices; Application for registration of medical devices; Declaration of prices of medical devices; Application for the License to import medical devices, etc.
This Decree takes effect from January 01, 2022.
For further details of the Decree 98/2021/ND-CP, Click here
translation of the Official Gazette of the Vietnam News Agency
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
Hanoi, November 8, 2021
On the management of medical devices
Pursuant to the Law on Organization of the Government dated June 19, 2015; the Law dated November 22, 2019 amending and supplementing a number of articles of the Law on Organization of the Government and the Law on Organization of Local Administration;
Pursuant to the Law on Investment dated June 17, 2020;
At the proposal of the Minister of Health;
The Government promulgates the Decree on the management of medical devices
Article 1. Scope of regulation
1. This Decree provides for the management of medical devices, including the classification of medical devices; the manufacture, clinical research, placement of medical devices on the market, the purchase and sale, export, import of medical devices, and the provision of services related to medical devices; the information and advertisement of medical devices; the management of medical devices prices, and the management and use of medical devices at medical facilities.
2. This Decree does not apply to:
a) Raw materials and semi-finished products used for manufacture of medical devices, except raw materials containing narcotic substances and precursors;
b) Raw materials used for manufacture of medical devices, which are samples of blood, serum, plasma, urine, fecal, body fluids or other human biological specimens that are subject to biosafety requirements upon import/export as prescribed by the law provisions;
c) Medical gases;
d) Fittings for medical devices;
dd) Research Use Only (RUO) and Laboratory Use Only (LUO) products.
Article 2. Interpretation of terms
1. “Medical device” means any instrument, implant, apparatus, material, in-vitro reagent and solution, or software that meets all the following requirements:
a) The device is intended by the product owner to be used, whether separately or in combination with each other, for human beings for one or more of the following purposes:
- To diagnose, prevent, supervise, treat, and alleviate a disease or to compensate for an injury or trauma;
- To examine, replace, modify, or assist surgery activities or physiological processes;
- To support or sustain life;
- To control conception;
- To disinfect medical devices;
- Provide information serving diagnosis, monitoring and treatment through the examination of human biological specimens.
b) The device does not use pharmacological, immunological, or metabolic mechanism of action in or on the human body, or if it is used, it may only assist the device to achieve any of the purposes as prescribed at Point a of this Clause.