Tag Archive for: regulatory consulting

Hong Kong Increases Prioritization of Registered Medical Devices

On July 4th, 2024, the Hong Kong Department of Health (DH) released an update on the upcoming enhancements to their procurement strategy concerning the registration of Applicable Medical Devices (AMDs).

Hong Kong Prepares Office for Mandatory Medical Device Regulations

On June 5th, Hong Kong’s Department of Health (DH) announced plans for the establishment of the Centre for Medical Products Regulation (CMPR).

Asia Actual Summit in Indonesia

April 23rd to 27th, 2024, Asia Actual Indonesia hosts Asia Actual USA, Singapore, China, Vietnam, Philippines, and Thailand, for a Summit.

Innovative Medical Device Registration in Japan

In 2019, Japan’s Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) introduced a innovative device registration designation system, called Sakigake, which is meant to streamline the regulatory pathway for qualifying medical products.

Medical Device Consultation in Japan

Medical device consultation in Japan is a very involved but essential process in registering a medical device. A significant part of the regulatory process in Japan is consultation meetings with the Pharmaceuticals and Medical Devices Agency (PMDA).

Asia Actual is the Best Medical Device Consulting Company in Asia

Manufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”