LATEST CIRCULATION LICENSE FOR MEDICAL DEVICES CLASS A, B 2024

A medical device that wants to be circulated on the market must be registered and...

Looking up medical devices import licenses

  1. Which medical devices are granted import licenses?  According to the regulations of the...

Form of Circulation Resistration Number for Medical devices

Medical devices need circulation number, circulation registration number, circulation registration certificate and other documents as...

Price declaration of medical devices

Medical devices are a special type of goods that can directly or indirectly affect the...

Circulation License for Medical Devices

In recent years, the demand for medical equipment in medical facilities nationwide has increased in...

Service Fee for Applying for Medical Equipment Import License

Currently, the management of import and export of medical equipment must comply with the principles...

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...