• 2020-02-14 07:48:41

The Medical Device Authority (MDA) of Malaysia has organised for a medical device exhibition to be held in Malaysia in April 2018. This event, the Malaysia Medical Device Expo, is an initiative by MDA to bring light to latest innovative technologies and advances of global medical devices, in hopes to provide all its stakeholders a one-stop centre for medical devices solutions.

• 2020-02-14 07:47:54

The Guidelines released by the Department of Health concerning Medical Device Registration is in place to be officiated following its publication. This shall be implemented a year after its effective date. Delayed implementation allows sufficient preparation for applicants in securing technical documents crucial to the registration process.

• 2020-02-14 07:47:14

In order to create favorable conditions for importers, the customs office shall handle the goods release procedures for special-purpose medical equipment and instruments, shall apply 5% VAT on the basis of written commitments and shall take responsibility before the law for the declaration.

• 2020-02-14 14:45:04

"The Guidelines for Accepting Overseas Clinical Data of Medical Devices" (hereinafter referred to as the "Guideline") was promulgated last January 11, 2018. CFDA has declared that they will be accepting overseas clinical trial data of devices registered in China.

• 2020-02-14 14:44:06

The CFDA has approved "The Administration Regulation for Online Medical Device Sales" (hereinafter referred to as the “Regulation”) proposed last November 7 2017, and will be fully implemented on March 1 2018. A total of 50 Clauses, including legislative purposes and scope, are outlined in the Regulation.

• 2020-02-14 14:43:01

Medical device standards are a unified basis for the development, production, operation, use and management of medical devices. These are also important indications of the development of medical device industry.

• 2020-02-14 07:54:36

On February 6, 2018, Medical Device Authority (MDA) of Malaysia released a Second Edition of the Guidance Document on Requirements for Labelling of Medical Devices. This GD serves a great purpose in informing the stakeholders on the additional requirements and content to be included in medical device labelling which are to be placed in Malaysia market or be exported.

• 2020-02-14 07:53:13

The medical device market in Vietnam is one of the fastest growing in the Asian region due to the government’s recent hospital improvement efforts. More than 90% of medical devices in Vietnam are imported. In this article, we take you go through Vietnam medical device market and importation work.

• 2020-02-14 14:56:10

Fast-growing the medical device market is by reading the domestic medical device manufacturing sector growth. In first-half of 2017, it grows 12.6% comparing to 2016 with total revenue at 142 billion RMB, according to Ministry of Industry and Information Technology of China

• 2020-02-14 14:55:31

In line with the rapid development of cloud computing, big data and artificial intelligence, mobile technology has been widely used in medical devices. Recently, China Food and Drug Administration (CFDA) released “Guidelines of Mobile Medical Device Registration." The provisions of this guideline was implemented from its effective date on December 29th, 2017.