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- Medical Device Risk Classification Problems in Vietnam May 13, 2024
- Philippines FDA Medical Device Labeling CMDN to CMDR Labeling Guidance May 7, 2024
- Innovative Medical Device Registration in Japan April 30, 2024
- Medical Device Consultation in Japan April 30, 2024
- Australia’s SaMD Regulatory Deadline April 16, 2024
- Thai FDA Regulatory Documentation Exemptions April 12, 2024
- Hong Kong MDD Adds Singapore as Reference Country April 4, 2024
- Philippines Incentivizing Local Medical Device Manufacturing March 19, 2024
- China’s Third Batch of UDI Implementation Deadline in June March 15, 2024
- Thai FDA Reduces Application Review Time March 13, 2024
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THAILAND ELEVATES REGULATORY STATUS OF BREAST IMPLANTS
/in Latest Updates, Thailand/by Bryan GilburgWith 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
/in Latest Updates, Philippines/by Bryan GilburgNew 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 China, Latest Updates/by Bryan GilburgIn 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 POSTPONES REGISTRATION DEADLINES FOR MOST NEWLY NOTIFIED MEDICAL DEVICES
/in India, Latest Updates/by Bryan GilburgINDIA TO REQUIRE REGISTRATION OF ALL CURRENTLY NON-NOTIFIED DEVICES
/in India, Latest Updates/by Bryan GilburgManufacturers 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
/in Latest Updates, Philippines/by Bryan GilburgAsia 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.
THAI FDA ADDS ‘CONCISE EVALUATION’ FOR QUALIFYING MEDICAL AND IVD DEVICES
/in Latest Updates, Thailand/by Bryan GilburgUpdate: INDIA SETS REGISTRATION DEADLINE FOR ULTRASOUND EQUIPMENT
/in India, Latest Updates/by Bryan GilburgIndia’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.