Learn medical device registration from a-z at Medgate

Are you looking to transition into the field of medical device registration but lack basic...

Conditions, Procedures, and Documentation for Opening a Medical Device Business Store

Opening a business store selling medical devices requires compliance with legal regulations, as medical devices...

Business conditions for the inspection and calibration services  of medical devices

Legal Basis Decree No. 98/2021/NĐ-CP issued on November 8, 2021: Management of medical devices. Decree...

ISO 13485- Medical Devices Quality Management System

What is ISO 13485? ISO 13485 is an international standard developed by the International Organization...

List of medical device must to be granted import permit 

(According to Article 6. Circular 05/2022/TT-BYT: Elaborating Decree No. 98/2021/ND-CP dated November 8, 2021 of...

Procedures and rules for the classification of medical devices

Legal Basis Decree No. 98/2021/ND-CP issued on November 8, 2021: On the management of medical...

What are A Class medical devices and What are they included?

The classification of medical devices is crucial for obtaining import licenses and declaring standards for...

Decision on Classification of Medical Device

Regulations on the Classification of Medical Devices Currently (In accordance with Article 2, Decision No....

Classification of Medical Devices a b c d

According to Decree No. 98/2021/ND-CP issued on November 8, 2021, on the management of medical...

The management of medical devices

On November 8, 2021, the Government issued Decree No. 98/2021/ND-CP on the management of medical...