Chương I Nghị định 98/2021/NĐ-CP: Những quy định chung

Chapter I

GENERAL PROVISIONS

Article 1. Scope

1. This Decree deals with the management of medical devices, including: classification of medical devices; manufacture, placement on the market, trading, import, export and provision of services related to medical devices; medical device information and advertising; management of prices of medical devices, and management and use of medical devices in health facilities.

2. This Decree does not apply to:

a) Ingredients and semi-finished products used for manufacture of medical devices, except raw materials containing narcotic substances and precursors;

b) Raw materials for manufacture of medical devices, including samples of blood, serum, plasma, urine, fecal, body fluids or other human materials that are subject to biosafety requirements upon import/export as prescribed by law;

c) Medical gas;

d) Medical device accessories;

dd) Research Use Only (RUO) and Laboratory Use Only (LUO) products.

Article 2. Definitions

1. “medical device” means any instrument, implant, apparatus, material, in-vitro reagent or calibrator, or software that meets all of the following requirements:

a) It is intended, by the product owner, to be used, whether alone or in combination, for human beings for the purpose of one or more of the following:

- diagnosis, prevention, monitoring, treatment or alleviation of disease, or compensation for an injury or trauma;

- investigation, replacement, modification or support of the anatomy or of a physiological process;

- supporting or sustaining life;

- control of conception,

- disinfection of medical devices;

- providing information serving diagnosis, monitoring or treatment through examination of specimens derived from the human body.

b) The device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means to serve the purposes mentioned in Point a of this Clause.

2. “in vitro diagnostic (IVD) medical device” means a reagent, calibrator, control material, instrument, apparatus, equipment or system or other product, whether used alone or in combination, intended by the product owner, to be used in vitro for the examination of specimens derived from the human body.

3. “personalized medical device” means a medical device that is specifically made in accordance with a duly qualified medical practitioner’s written prescription, which gives, under his responsibility, specific design characteristics and intended for the sole use of a particular individual.

4. “accessory” means an article that is intended specifically by its product owner to be used together with a particular medical device to enable or assist that device to be used in accordance with its intended purpose.

5. “product owner” means any organization or person that:

a) supplies the medical device under its/his own name, or under any trademark, design, trade name or other name or mark owned or controlled by it/him; and

b) is responsible for designing, manufacturing, assembling, processing, labeling, packaging, refurbishing or modifying the medical device, or for assigning to it a purpose.

Article 3. Principles of management of medical devices

1. The quality, safety and efficacy of the medical device must be verified.

2. Adequate, accurate and timely information about specifications and intended purpose of the medical device and potential risks to the user must be provided.

3. The traceability of medical devices must be ensured.

4. Medical devices shall be managed in accordance with risk classification rules and relevant national technical regulations and/or national standards issued or recognized by competent regulatory authorities or announced standards applied by organizations/individuals in accordance with regulations of law.

5. Medical devices that are measuring devices or radiation equipment must be managed in accordance with regulations of the law on measurement, the law on atomic energy and regulations herein.

6. Chemicals and preparations intended solely for disinfection of medical devices shall be managed in accordance with regulations herein. Chemicals and preparations intended for other purposes, in addition to the disinfection of medical devices, shall be managed in accordance with regulations of law on insecticidal and germicidal chemicals and preparations for medical and household use.

7. Medical devices, raw materials or ingredients used for manufacturing of medical devices, and substances for external quality assessment that contain narcotic substances and precursors must be managed in accordance with regulations of law on drug control, if they are imported or exported, and regulations herein.

8. Regulations on classification, issuance of registration number, and eligibility requirements for trading of medical devices laid down herein shall not apply to:

a) Software used for medical devices;

b) Medical devices that are traded as normal goods and imported as gifts or presents given to individuals or organizations other than health facilities.