• 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:

• 2020-02-14 14:53:03

Malaysian lawmakers take medical device related issues pretty seriously, starting with the introduction of the Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012. A faulty pacemaker or even a leaking catheter are the last things patients need to worry about as they may pose various levels of threat to their lives.

• 2020-02-14 14:52:01

Starting from January 1, 2018, the Malaysian Communications and Multimedia Commission (MCMC) no longer permits any kind of Short Range Devices (SRD) and Radio Frequency Identification Devices (RFID) to operate in the frequency range from 869 MHz to 870 MHz.

• 2020-02-14 14:50:54

On November 16th of 2017, Philippine Food and Drug Administration (FDA) announced that the importation and exportation of radiation devices that can be ionizing and non-ionizing shall not be allowed to enter the country unless a Clearance for Customs Release (CFCR) has been issued by the Center for Device Regulation,

• 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.

• 2020-02-14 14:49:16

On December 4, 2017, Philippine Food and Drug Administration (PFDA) announced that Philippine Food and Drug Administration (PFDA) Cashier will be accepting cash payments for all applications from 8:00 AM to 5:00 PM, Monday to Friday, at the Food and Drug Action Center (FDAC), Civic Prime Building, Filinvest City, Alabang Muntinlupa City, until further notice.

• 2020-02-14 14:48:09

This means that the Marketing Authorization License for Class B, C, and D medical devices will be delayed for one year from the original date set forth under Decree 36. Thus, with the official release of the Dispatch 7165 in Vietnam, some specific interim regulations are as follows: