Tag Archive for: notified body

Taiwan’s New TCP III in Effect as of January 1, 2022

/in , /by

The Taiwan FDA implemented the third generation of the Taiwan-Europe Technical Cooperation Program (TCP III) on January 1, 2022.

Read more

PHILIPPINES OFFICIALLY LAUNCHES NEW MEDICAL DEVICE REGULATIONS

/in , /by

New medical device regulations in the Phillipines have been launched. Class A, Class B, Class C, and Class D medical devices will all be affected.

Read more

4 PRODUCT DEVELOPMENT DECISIONS THAT IMPACT SALES PERFORMANCE IN ASIA

/in , , , , , , , , , , /by

US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.

Read more

NEW OFFICE SPACE FOR ASIA ACTUAL PHILIPPINES

/in , /by

Asia Actual is excited to announce the dedication of our new office space in the Philippines. The investment reflects the company’s commitment to the Philippines market and expectations for growth.

Read more

INDIA TO REQUIRE REGISTRATION OF ALL CURRENTLY NON-NOTIFIED DEVICES

/in , /by

Manufacturers of non-Notified medical devices are advised to evaluate their products of interest for India and begin to build their application files for a Registration Certificate

Read more

THAILAND ELEVATES REGULATORY STATUS OF BREAST IMPLANTS

/in , /by

With Regulation B.E. 2562 (revision from regulation B.E. 2540), the Thai FDA increased the regulatory status of breast implants from Notified to Licensed (Class 4)

Read more

HONG KONG ADVANCES TOWARDS MANDATORY MEDICAL DEVICE REGISTRATION

/in , /by

Hong Kong’s Department of Health officially changed the name of the Medical Device Control Office (MDCO) to the Medical Device Division (MDD) at the end of 2019.

Read more

THAILAND SUSPENDS PLAN TO REGULATE HAND SANITIZER AS MEDICAL DEVICE

/in , /by

In the wake of the COVID-19 outbreak, the Thai FDA announced on March 5, 2020 that they will cancel their plans to begin regulating alcohol gel sanitizers as medical devices.

Read more