The 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.
President 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.
This 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.
On 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.
A 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.
The 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%.
Asia Actual is excited to announce the dedication of our new office space in the Delhi area.
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- Hong Kong Refines Medical Device Post-Market Surveillance Report Form January 27, 2023
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