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- 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
- Vietnam’s MoH Updates Class C and D Application Requirements February 29, 2024
- India Changes Medical Device Application Processing System February 27, 2024
- India’s Class C and D Import License Enforcement Deadline Fast-Approaching February 20, 2024
- Thai FDA QMS Updates to Affect GDP, GMP, and GCP February 14, 2024
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THAILAND 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
INDIA PLANS TO REGULATE ALL MEDICAL DEVICES
/in India, Latest Updates/by Bryan GilburgThe CDSCO review process to generate a MD Form 15 typically takes 6 to 9 months with 6 to 8 weeks of application preparation. To be safe, manufacturers should begin the MD Form 15 application process 12 months before any deadline.
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 and Import License.