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- Key Takeaways from VietNam’s CSDT Conference July 12, 2024
- Hong Kong Increases Prioritization of Registered Medical Devices July 12, 2024
- TGA Emphasizes Medical Device Distribution Record-Keeping July 10, 2024
- Singapore’s HSA Increases Medical Device Registration Fees July 2, 2024
- TGA Updates Rules for Medical Device Manufacturers June 25, 2024
- Software as a Medical Device in Thailand June 17, 2024
- Hong Kong Prepares Office for Mandatory Medical Device Regulations June 14, 2024
- Australia Issues New Guidance on AIMD and MLMD June 4, 2024
- India Extends Deadline for Class C and D Import Licenses May 28, 2024
- Indonesia Invests in Quality Healthcare Access May 22, 2024
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THAILAND SUSPENDS PLAN TO REGULATE HAND SANITIZER AS MEDICAL DEVICE
/in Latest Updates, Thailand/by Bryan GilburgIn 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.
INDIA OFFICIALLY REQUIRES REGISTRATION OF ALL NON-NOTIFIED DEVICES
/in India, Latest Updates/by Bryan GilburgOn February 11th, 2020 the Ministry of Health and Family Welfare published the Medical Device Rules, 2020 as an amendment to the Medical Device Rules
HONG KONG ADVANCES TOWARDS MANDATORY MEDICAL DEVICE REGISTRATION
/in Latest Updates, Thailand/by Bryan GilburgHong 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.
CHINA ENCOURAGES LOCAL MANUFACTURING OF FOREIGN MEDICAL DEVICES
/in China, Latest Updates/by Bryan GilburgChina 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.
ASIA ACTUAL INTERVIEW: THE FUTURE OF MEDTECH IN ASEAN
/in Latest Updates, Thailand/by Bryan GilburgLearn about the significant opportunities and challenges medical device companies can expect when accessing this dynamic and thriving market.
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.