• 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 14:50:04

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 14:48:09

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:

• 2020-02-14 15:23:25

On November 14th 2017, Center for Medical Device Evaluation (CMDE) released "The Draft of the Guidance of Accepting the Overseas Clinical Trial Data for Medical Device", which is applicable to medical devices (including in vitro diagnostic reagents, IVDs).

• 2020-02-14 15:21:19

Head of Indonesia Ministry of Health, Nila Moeloek, said that the Ministry is trying to accelerate medical device and household products licensing by developing Single Submission and Indonesia Single Risk Management (ISRM) system. By using this system, hope the time consumed for licensing process can be accelerated,

• 2020-02-14 15:20:15

India's central medical device regulator, the Central Drugs Standards Control Organization (CDSCO) published, on November 1, 2017, a revised risk classification of medical devices and IVDs on the basis of their intended use. This is an extremely important development for the medical device and IVD industry because from January 1, 2018 onwards,

• 2020-02-15 06:25:26

Indonesia is the world’s fourth most populous country. Supporting the United Nations (UN) Millennium Development Goals (MDGs), the Indonesian government released their national development plan (RPJMN 2015, Propenas) in an effort to reduce poverty. Healthcare is one of the top priorities in Indonesia’s national development agenda.

• 2020-02-15 06:24:19

The purpose is to amend the clauses in the Supervision and Administration Regulation which are in conflict with the clauses of the Innovation Opinion, and to consummate the relevant regulations.