• 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 07:52:35

In an effort to showcase the latest developments in the medical, dental and pharmaceutical industry, the MEDICAL Philippines, in partnership with Pharma Philippines and Dental Philippines will be holding a Medical Expo which serves to bring international congregation of Medical & Healthcare equipment and services, Dental Technology,

• 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.

• 2020-02-14 14:54:42

In order to enhance the inspection of imported drugs and medical devices, China Food and Drug Administration (CFDA) has issued “Draft of Regulations for The Administration of Overseas Inspection of Drug and Medical Devices”. It is currently looking for public comments until January 24, 2018.

• 2020-02-14 14:54:11

Before undergoing registration application in China, medical devices shall be sent to medical device inspection agencies for examination to ensure that the products meet national standards. CFDA has issued a notice on the examination work to ensure the efficiency of registration of medical devices. The details of the notice are as follows: