• 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 07:52:35

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 14:54:42

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 14:52:01

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 15:24:31

According to the post-show figures from the organizer, PT. OSI, indicate that medical device should be set for a prosperous year ahead in 2018 of a record-breaking attendance of more than 43,869 and 518 exhibitors from 46 countries. Around 40% of exhibitors were international, with more than 54% from China, 22% from Taiwan and 12% from South Korea.

• 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 15:22:02

The Clause 29th of "The Guidance of Registration for In-vitro Diagnostic Reagent” clarifies that for in-vitro diagnostic (IVD) reagents exempt from clinical trial, the applicant is responsible for the evaluation of the clinical performance of the IVD reagents by means of evaluating the clinical samples from the intended use, interference factors, comprehensive literatures and other pre-clinical data.

• 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,

• 2020-02-14 15:18:33

On November 10, 2017, Philippine Food and Drug Administration (FDA) announced that the technical review and reevaluation process of 51 contraceptives products covered by a resolution issued by the Supreme Court – the highest court and judiciary power in the Philippines, has been completed.