• 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.

• 2020-02-15 06:20:38

A new Circular Letter was released by Medical Device Authority (MDA) on October 2, 2017, in which MDA recognizes Institute of Medical Research (IMR) Malaysia as a credible source to provide clinical evaluation data for conformity assessment purposes conducted by a Conformity Assessment Bodies (CAB) in Malaysia. This Circular Letter comes into effect starting October 2, 2017.

• 2020-02-15 06:19:28

The Medical Device Authority (MDA) is inviting all its customers to participate in a Customer Satisfaction Survey. MDA is always trying to improve quality of service provided to all its customers.

• 2020-02-15 06:18:22

On November 1st of 2017, the Medical Device Authority (MDA) released the Draft of a new Guidance Document on the Import and/or Supply of Unregistered Medical Devices for The Purpose Of Demonstration for Marketing or Education. This Guidance Document came just in time to answer foreign manufacturers and local distributors’ concerns on whether unregistered medical devices are allowed to be imported into Malaysia for non-commercial purposes, for a specified timeline.