• 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.

• 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.

• 2020-02-15 06:22:45

According to the “Regulations for the Supervision and Administration of Medical Devices,” "Provisions for Medical Device Registration,” “Provisions for In-vitro Diagnostic Reagent Registration,” and “Provisions for Instructions and Labels of Medical Devices,” when applying for medical device listing in China, the applicant name shall be in Chinese.

• 2020-02-15 06:21:59

In order to improve the design of clinical trials of medical devices in the country, the Center for Medical Device Evaluation (CMDE) drafted the guidelines for the design of clinical trials of medical devices, and asked for the public’s opinion.       

• 2020-02-15 06:21:19

Ministry of Science and Technology of the People´s Republic of China published the new administration process of human genetic resources in clinical trial in the end of October.