• 2021-02-22 02:35:59

Taiwan FDA has announced a Product Registration Guidance for Artificial Intelligent/Machine Learning based Software Medical Device, or so-called AI/ML-Based SaMD. The guidance provides overall requirements and forethoughts for manufacturers to consider and describe when designing and establishing the products.

• 2020-04-14 08:47:59

In order to promote high-quality medical device industry, China is looking for ways to encourage domestic manufacturers to adopt higher technology and introduce incentives for foreign manufacturers with investments by local establishments.

• 2020-02-21 06:56:04

In Indonesia, E-Katalog become the most popular platform for the public hospital or government related institution to find required medical device equipment. In October, Government invite Medical Device Company to submit an offering of Medical Devices and Household Health Supplies products to be included in E-Katalog.

• 2020-02-12 14:24:17

Just recently, a number of advisories concerning recalls of healthcare products were observed to increase. These advisories being referred to are a result of product recalls conducted in accordance with the guideline issued in mid of 2016.

• 2020-02-14 07:43:27

Based on a recently issued circular letter, No. 3 Year 2017 (Rev.1), MDA has reiterated the implementation and enforcement date for the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combinations Products, which will be strictly enforced in Malaysia starting July 1st, 2019.

• 2020-02-14 14:50:04

On December 15, 2017 Philippine Food and Drug Administration (FDA) announced some changes in the Application of Variation of Certificate of Product Registration for Medical Devices.