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.
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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)
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.
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.
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
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.
Z – MEDICA 2019
Discuss new distribution options available in any Asia Pacific country, and be briefed on critical market access issues in the region. Contact us today
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.