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- 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
- Thai FDA Fast Track Route for COVID Related Products to Stop November 4, 2022
- China’s NMPA Begins Issuing Registration Certificates Electronically November 1, 2022
- Good Distribution Practice Requirements in Indonesia October 28, 2022
- Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea October 25, 2022
- India Issues New Sales License Requirement for Medical Devices October 10, 2022
- Expedited Market Access Now Available in Philippines October 4, 2022
- India Grants Import License Grace Period for Class A/B Devices September 30, 2022
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The Philippines FDA Publishes New Guidance on Medical Device Recalls
/in Latest News, Philippines/by AsiaActualAdminThe Philippines Food and Drug Administration (FDA) has published a Circular clarifying medical device recall requirements referenced in sections 5 (k) of the FDA Act of 2009. The requirements will go into effect in September of 2016.
The Philippines FDA No Longer Requires Physical Samples for Medical Device Registration
/in Latest News, Philippines/by AsiaActualAdminThailand FDA Publishes New Guidance on Post-Market Vigilance
/in Latest News, 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 News, 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 News, 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 News/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 News/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 News/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%.