A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.

PHILIPPINES TO BAN POWDERED SURGICAL AND EXAM GLOVES

/in , /by

With FDA Advisory No. 2017-180 issued on June 20, 2017 the Philippines Food and Drug Administration (FDA) announced intentions to gradually switch to power-free gloves.  A full ban of powdered surgical and examination glove will go into effect on January 1, 2019 effecting the importation, distribution and sale of specified devices.

Read more

Indonesia Publishes Guidelines for Clinical Trail Approvals for Medical and Diagnostic Devices

/in , /by
Read more

Korea Intends to Increase Medical Device Registration Fees in 2017

/in , /by

The Korean government has announced intentions to increase the official fees charged by the Ministry of Food and Drug Safety (MFDS) and Medical Device Information and Technology Assistance Center (MDITAC) for processing medical device conformity assessment applications.

Read more

INDIAN GOVERNMENT REMINDS MEDICAL DEVICE INDUSTRY OF PENDING REGULATORY CHANGES

/in , /by

Exactly 6 months before the new Medical Device Rules, 2017 are to take effect the Drugs Controller General (India), Dr. G.N. Singh, published a notice that serves as a reminder to industry to prepare for the coming changes.

Read more