What are the conditions for placement of medical devices on the market of Vietnam? What are the principles of management of medical devices in Vietnam?
What are the conditions for placement of medical devices on the market of Vietnam?
Pursuant to the provisions of Article 22 of Decree No. 98/2021/ND-CP stipulating as follows:
Conditions for placement of medical devices on the market
1. A medical device may be placed on the market if it meets the following conditions:
a) It has been granted registration number or import license in accordance with regulations laid down in this Decree, except the cases specified in Clause 8 Article 3 and Article 24 of this Decree;
b) Its label contains adequate information in accordance with regulations of law on labeling of goods;
c) Instructions for use of the medical device are given in Vietnamese;
d) Information about warranty center, conditions and time for warranty, except disposable medical devices defined by product owners or cases where there are documents proving that the medical device is not under warranty.
2. If the information specified in Point c and Point d Clause 1 of this Article is not provided upon the medical device itself, it must be provided in the form of electronic information for which instructions for search must be available on the label of the medical device.
However, in Clause 2, Article 1 of Decree No. 07/2023/ND-CP, the conditions for placement of medical devices on the market as follows:
A medical device may be placed on the market if it meets the following conditions:
- It has been granted registration number, marketing authorization number, certificate of registration or import license in accordance with regulations on management of medical devices or in the cases specified in Point d Clause 2 Article 76 of this Decree, except the following cases:
+ The medical device is liquidated as prescribed by laws;
+ The medical device reaches its expiry date;
+ The defect that is harmful to users’ health cannot be repaired as prescribed in Clause 4 Article 34 of this Decree;
+ The use of medical device is prohibited by a regulatory authority.
- Its label contains adequate information in accordance with regulations of law on labeling of goods;
- Instructions for use of the medical device are given in Vietnamese language;
- Information about warranty center, conditions and time for warranty, except disposable medical devices defined by the product owner or cases where there are documents proving that the medical device is not under warranty.
- If the import license is available as prescribed in Points a, b, c, d and dd Clause 1 Article 48 of Decree No. 98/2021/ND-CP, the satisfaction of the condition in Point d Clause 1 Article 22 of Decree No. 98/2021/ND-CP is not required.
- If the information specified in Point c and Point d Clause 1 Article 22 of Decree No. 98/2021/ND-CP is not provided upon the medical device itself, it must be provided in the form of electronic information for which instructions for search must be available on the label of the medical device.
What are the conditions for placement of medical devices on the market of Vietnam? What are the principles of management of medical devices in Vietnam?
What are the principles of management of medical devices in Vietnam?
Pursuant to the provisions of Article 3 of Decree No. 98/2021/ND-CP stipulating the principles of management of medical devices in Vietnam as follows:
- The quality, safety and efficacy of the medical device must be verified.
- Adequate, accurate and timely information about specifications and intended purpose of the medical device and potential risks to the user must be provided.
- The traceability of medical devices must be ensured.
- 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.
- 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.
- 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.
- 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.
- Regulations on classification, issuance of registration number, and eligibility requirements for trading of medical devices laid down herein shall not apply to:
+ Software used for medical devices;
+ Medical devices that are traded as normal goods and imported as gifts or presents given to individuals or organizations other than health facilities.
Remove many problems about medical devices when issuing the new Decree?
On March 3, 2023, the Government issued Decree No. 07/2023/ND-CP, amending Decree No. 98/2021/ND-CP on management of medical devices.
The highlights of Decree No. 07/2023/ND-CP are as follows:
- Automatically renew import license, registration number, clear problems in importing medical devices:
To solve the shortage of equipment due to the number of import permits for medical devices issued from January 1, 2018 to December 31, 2021, which expired on December 31, 2022 and the registration number for circulation of medical devices is In vitro diagnostic biological products issued from January 1, 2014 to December 31, 2017 expired on December 31, 2022, meanwhile, the progress of issuing new registration numbers of medical devices is slow, not meeting the demand.
- Moving from pre-inspection to post-test:
The Government's guiding view in the Decree determines that from 2025, it will change from pre-inspection to post-inspection, the circulation number has an indefinite value associated with the responsibility of enterprises for information on medical devices and the responsibility of management agencies in the organization of inspection and examination.
- Change management and declaration of medical devices prices
Decree No. 07/2023/ND-CP stipulating the implementation of price listing for all medical devices at places prescribed by law on prices or on the website of the Ministry of Health (current regulations require must declare the price of medical devices for all more than 200,000 types, each type has many different configurations, technical features, etc.
Only declare prices for medical devices when there is an abnormal fluctuation in price affecting the supply of medical devices, the buyer's ability to pay, and the solvency of the Health Insurance Fund.
- Handling of medical devices with registration number revoked
Decree No. 07/2023/ND-CP also stipulates to solve problems in the handling of medical devices when the registration number is revoked, so it may cause difficulties for businesses, people, and state management agencies in implementing and handling medical equipment whose circulation registration number has been revoked.
- Amendment of regulations on import and export and temporary import and re-export of medical devices
In order to remove difficulties in import and export and temporary import and re-export of medical devices
The Government has considered to issue a Government Resolution to pilot mechanisms and policies to ensure that drugs, medical devices and payment of medical examination and treatment costs are covered by health insurance in accordance with the specific conditions of the health sector until relevant regulatory documents are promulgated.
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