Get in touch.

US

HEADQUARTERS

515 Congress Avenue, Suite 2100
Austin, TX 78701

+1 512 898-9222

SOUTHEAST ASIA

HEADQUARTERS

116 Changi Road, #04-05
Singapore 419718

+65 3138-4148

This contact form is deactivated because you refused to accept Google reCaptcha service which is necessary to validate any messages sent by the form.

LATEST NEWS.

Navigating the New Vietnamese Public Medical Device Pricing Portal

The new Medical Device Pricing Portal was opened to the public on November 20th with the goal of setting new international standards for medical device sales transparency. The medical device section is split into 2 sections, the Medical Equipment Price and Pricing Information on Winning Bids. On one side, users can view product listings and on the other, review all final government purchases, including contracted pricing.

China’s Green Pathway Registration for Innovative Medical Devices

China’s NMPA created a registration route specifically for innovative medical devices called the Innovative Green Pathway in 2014 and is based on the CFDA Order No. 13 2014. Since this registration route tends to cause some confusion, specific clarifying details are provided.

Thailand Implements New Medical Device Regulations

On February 15th the Thai FDA published significant new guidance governing the classification, technical documentation requirements, fee schedule and transition plan for medical device registration. This much anticipated action harmonizes the Thailand’s Medical Device Act/Ordinance B.E. 2562 (2019) (Issue 2) with the ASEAN Medical Devices Directive.