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- CDSCO Issues Updates to IVD Classification List in India November 29, 2023
- Embracing Innovation and Collaboration: Highlights from the 15th CII Global MedTech Summit November 2, 2023
- Bangladesh LAUNCHES NEW MEDICAL DEVICE REGULATIONS October 17, 2023
- India Grants Import License Grace Period for Class C/D Devices October 16, 2023
- Indonesia to Require Post-Market In-Country Testing of Medical Devices October 11, 2023
- China’s NMPA Updates Medical Device Classification Catalogue September 19, 2023
- Thai FDA Drafting New Guidance for SaMD and AI Device Registration September 18, 2023
- China NMPA Adds 47 Products to Clinical Trial Exemption List August 22, 2023
- New Plastic Waste (PWM) Rules Affect Medical Device Importers in India August 22, 2023
- China to Regulate Medical Device Advertising August 2, 2023
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India Adds First Medical Device to Price Control System
/in India, Latest Updates/by AsiaActualAdminWith the publishing of the ‘Drug (Prices Control) third amendment Order, 2016’ on December 21, 2016, coronary stents were added the list of devices subject to government price controls. Included in the product definition are bare metal stents, metallic drug eluting stents, and bio-resorbable vascular scaffold/biodegradable drug eluting stents.
Comprehensive Medical Device Regulations Coming to India
/in India, Latest Updates/by AsiaActualAdminThe Indian Central Drugs Standard Control Organization (CDSCO) took another step closer to implementing comprehensive medical device regulations. On October 18th, a draft of the ‘Medical Device Rules, 2016’ was formally published for public comment. These Rules are similar to those informally circulated in July to industry stakeholders. A link to the document is available here on the Asia Actual website (the English version starts on page 145).
The Philippines FDA Publishes New Guidance on Medical Device Recalls
/in Latest Updates, 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 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.