Medical Device Regulatory News in Asia

At the July 25th Drugs Technical Advisory Board (DTAB) meeting, a resolution passed to add (1) glucometers, (2) blood pressure monitoring devices, (3) nebulizers, and (4) digital thermometers to the list of notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India.

Indonesia Tightens Enforcement of Medical Device Licensing

July 25, 2018/in Indonesia, Latest Updates/by Bryan Gilburg

With the implementation of Regulation No. 60, 2017 on February 1st, 2018 the Indonesia government tightened enforcement of medical device licensing requirements.

Philippines Proposes New Fees for Medical Device Registration

July 11, 2018/in Latest Updates, Philippines/by Glend Llantada

The Philippines Department of Health published a draft schedule of fees to be charged for medical device registrations under the new Rules next year. As per Administrative Order 2018-0002, medical devices will be classified by increasing risk from A to D.

Russia Streamlines Medical and IVD Device Regulations

June 18, 2018/in Latest Updates, Russia/by Bryan Gilburg

On the May 31st Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor) published Decree No. 633 which includes provisions that significantly improve the registration process for medical and IVD devices. The changes go into full effect on June 13th, 2018.

India to Regulate More Medical Devices

May 25, 2018/in India, Latest Updates/by Bryan Gilburg

At the May 16th Drugs Technical Advisory Board (DTAB) meeting, a resolution passed that expands the list of notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India. The following device categories are affected: