Instructions for the Procedure to Continue Circulating Class C and D Medical Devices in Cases Where the Owner Ceases Production, Declares Bankruptcy, or is Dissolved

In the field of medical devices, ensuring continuity in circulation and maintenance is a critical...

Dossier and Procedures for Obtaining Marketing Authorization (MA) for IVD Medical Devices of Class C and D with National Technical Regulations

In the context of international integration and the growing demand for quality assurance in the...

NOTES ON DECLARING ELIGIBILITY FOR MEDICAL DEVICE TECHNICAL CONSULTING SERVICES

In the context of the healthcare sector’s ongoing modernization, medical devices are becoming increasingly sophisticated,...

LABELING REQUIREMENTS FOR MEDICAL DEVICES

Medical device labeling is not only a means of product identification but also a legal...

Intructions for Searching Registration Number of Medical Devices

To be legally marketed, a medical device must be issued a registration number by Vietnam’s...

Template for medical device import license

Applying for an import license of medical devices The medical devices lacking a circulation number...

Regulations on importing medical devices

Currently, the state encourages domestic enterprises to produce medical devices for export. However, the increasing...

Enterprises without circulation registration numbers will not be able to import class C, D medical devices from 2025.

According to the provisions of Decree 07/2023/ND-CP, Section 18 of the amendment and supplement to...

PROCEDURES FOR IMPORTING MEDICAL DEVICES CLASS A

In recent years, the import of medical devices for medical examination and treatment at facilities...

GUIDELINES FOR REGISTERATION OF MEDICAL DEVICES

Enterprises need to register medical devices with the relevant authorities as outlined in Decree 98/2021...