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

ASIA ACTUAL INTERVIEW: THE FUTURE OF MEDTECH IN ASEAN

Learn about the significant opportunities and challenges medical device companies can expect when accessing this dynamic and thriving market.

Update: INDIA SETS REGISTRATION DEADLINE FOR ULTRASOUND EQUIPMENT

India’s Central Drugs Standards Control Organization (CDSCO) has officially added ‘ultrasound equipment’ to the Notified list of medical devices that require pre-market approval in India.

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

CHINA ENCOURAGES LOCAL MANUFACTURING OF FOREIGN MEDICAL DEVICES

China has been making efforts to encourage more direct investment. Along with the new Foreign Investment Law, the NMPA has also announced incentives for manufacturers opening facilities in China by making the application process easier and faster. 

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)