Tag Archive for: device manufacturers

Submission Changes in China: ToCs and the eRPS

Manufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.

CHINA AMENDS MEDICAL DEVICE APPLICATION SUBMISSION PROCESS

In an ongoing effort to refine and improve the systems and procedures for medical device registration in China, the National Medical Products Administration or NMPA (previously the CFDA) moved to a new on-line submission system and harmonized the applications table of contents to international standards.

NEW OFFICE SPACE FOR ASIA ACTUAL PHILIPPINES

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.

INDIA TO REQUIRE REGISTRATION OF ALL CURRENTLY NON-NOTIFIED DEVICES

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

PHILIPPINES OFFICIALLY LAUNCHES NEW MEDICAL DEVICE REGULATIONS

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.

THAILAND ELEVATES REGULATORY STATUS OF BREAST IMPLANTS

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)