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- Hong Kong Refines Medical Device Post-Market Surveillance Report Form January 27, 2023
- Thailand FDA Provides Guidance on Classification of Physical Therapy Devices January 19, 2023
- Philippines FDA Issues Advisory Reiteration Against Unethical Business Practices January 13, 2023
- Indonesia e-Catalogue Implementation Review, December 2022 December 30, 2022
- The Vietnamese MOH Issues Draft Decree to Address Delays December 14, 2022
- Thailand FDA Publishes Guidance for Software as Medical Device December 14, 2022
- China NMPA Updates Compulsory Standards for Medical Devices December 6, 2022
- China NMPA Updates Classification of Sodium Hyaluronate Products November 18, 2022
- India Issues Final Notice Exempting Certain Class A Medical Devices November 14, 2022
- China’s NMPA Publishes Classification Catalogue Adjustments for Comment November 8, 2022
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The Philippines FDA No Longer Requires Physical Samples for Medical Device Registration
/in Latest Updates, Philippines/by AsiaActualAdminThailand FDA Publishes New Guidance on Post-Market Vigilance
/in Latest Updates, Thailand/by AsiaActualAdminThe Thai Food and Drug Administration (FDA) has published a Notification clarifying post-market vigilance requirements referenced in sections 5 (1) and 41 (5) of the Medical Device Act B.E. 2551 (2008). The requirements are to go into effect in this November and are considered an important step toward harmonization of the Thai regulations with the ASEAN Medical Device Directive.
The Philippines Appoints New FDA Director General
/in Latest Updates, Philippines/by AsiaActualAdminPresident Rodrigo Duterte appointed Charade Galang-Puno as the new Director General of the Philippines Food and Drug Administration. Dr. Galang-Puno is one of 42 appointees sworn in on Monday, August 15 at the Malacañang Palace in Manila.
Philippines FDA Moves to Streamline Submission Systems for Device Registration and Licensing
/in Latest Updates, Philippines/by AsiaActualAdminThis month, the Center for Device Regulation, Radiological Health and Research (CDRRHR) has relocated from the Department of Health in Manila to new facilities within the FDA central compound in Alabang.
India Publishes New Medical Device Regulations
/in India, Latest Updates/by AsiaActualAdminOn July 12, the Ministry of Health and Family Welfare published a draft of new medical device regulations (Medical Device Rules, 2016) which will require registration for all medium to high risk medical and IVD devices. Implementation could happen as early as year end.
Medical Device Re-Registration in Hong Kong
/in Hong Kong, Latest Updates/by AsiaActualAdminA large number of medical device listings in Hong Kong are coming to the end of their 5-year validity period and must undergo a re-registration process in order to maintain an active Medical Device Listing.
Medical Device Pricing Controls May Be Coming to India
/in India, Latest Updates/by AsiaActualAdminThe National Pharmaceutical Pricing Authority (NPPA) in India is considering applying the Drug Price Control Order (DPCO) to medical devices. Importers of notified cardiovascular and orthopedic devices have been put on notice to control mark ups, or the NPPA will intercede. If so, limits will be applied to the difference between landed cost and the Maximum Retail Price (MRP) anticipated to be around 35%.
New Office Space for Asia Actual India
/in India, Latest Updates/by AsiaActualAdminAsia Actual is excited to announce the dedication of our new office space in the Delhi area.