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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
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- India Extends Deadline for Class C and D Import Licenses May 28, 2024
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THAILAND ELEVATES REGULATORY STATUS OF DERMAL FILLERS
/in Latest Updates, Thailand/by Bryan GilburgTHAILAND NOTIFIES ALCOHOL-BASED STERILIZATION PRODUCTS
/in Latest Updates, Thailand/by Bryan GilburgThe Thai FDA increased the regulatory status of alcohol-based sterilization devices from General to Class 2 Notified.
HONG KONG LAUNCHES EXPEDITED MEDICAL DEVICE REGISTRATION PILOT PROGRAM
/in Hong Kong, Latest Updates/by Bryan GilburgINDIA COMPLIANCE MAINTENANCE: NOTIFIED BODY CHANGE
/in India, Latest Updates/by Bryan GilburgGiven recent conditions of Brexit, many companies are impacted with changes regarding their notified body. This change ultimately changes the CE Mark on labeling, thus requiring amendments to any existing Import Licenses in India.
INDONESIA CALLS FOR NEW ROUND OF E-CATALOGUE APPLICANTS
/in Indonesia, Latest Updates/by Bryan GilburgIn response to the overwhelming interest to a June invitation for registered medical device license holder to request inclusion of their device/s in the 2019 e-Catalogue enrollment, the Indonesia Ministry of Health (MOH) has extended the application deadline.
eRPS System: China National Medical Product Administration’s (NMPA) medical device registration system
/in China/by Bryan GilburgManufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.
PHILIPPINES TO HOST ASEAN MEDICAL DEVICE COMMITTEE MEETING / TRAINING
/in Latest Updates, Philippines/by Bryan GilburgThe 8th ASEAN Medical Device Committee Meeting (AMDN) will take place in Manila from August 4-8, 2019.
INDONESIA E-CATALOGUE ENROLLMENT DEADLINE JUNE/JULY 2019
/in Indonesia, Latest Updates/by Bryan GilburgThe Indonesian government procurement agency, known as LKPP, has invited medical device companies to apply for any existing e-Catalogue contract extensions by July of 2019