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- Hainan Island’s Special Access Program for Medical Devices August 2, 2024
- China Updates Medical Device Clinical Evaluation Pathway Guidance July 29, 2024
- China Releases New List of Standards for Medical Device Registration July 26, 2024
- Key Takeaways from VietNam’s CSDT Conference July 12, 2024
- Hong Kong Increases Prioritization of Registered Medical Devices July 12, 2024
- TGA Emphasizes Medical Device Distribution Record-Keeping July 10, 2024
- Singapore’s HSA Increases Medical Device Registration Fees July 2, 2024
- TGA Updates Rules for Medical Device Manufacturers June 25, 2024
- Software as a Medical Device in Thailand June 17, 2024
- Hong Kong Prepares Office for Mandatory Medical Device Regulations June 14, 2024
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Thailand FDA to Improve Medical Device Advertising Review Times
/in Latest Updates, Thailand/by Noi SuwannabotIn a training seminar held on January 15 and 16, 2024, by the Thai FDA on the Full Common Submission Dossier Template (CSDT), the TFDA stated their intention to improve the advertising approval process. Per the Deputy Secretary General, they plan to implement new processes meant to help expedite the approvals of advertisement applications.
Hong Kong MDD Issues New Technical Reference Document for AI-MD
/in Hong Kong, Latest Updates/by Bryan GilburgOn January 3, 2024, Hong Kong’s Medical Device Division (MDD) issues the Technical Reference document TR-008: Artificial Intelligence Medical Devices (AI-MD). It provides clarity for devices using AI (AI-MD) and machine learning, including Continuous Learning Capability (CLC) and the technical requirements expected for listing these medical devices on the Medical Device Administrative Control System (MDACS).
Hong Kong MDD Issues Technical Reference for SaMD and SiMD
/in Hong Kong, Latest Updates/by Bryan GilburgHong Kong’s Medical Device Division has released a new technical reference document related to software medical devices (SaMD and SiMD). Released on December 29, 2023, TR-007: Software Medical Devices and Cybersecurity, aims to provide more clarity for Software in a Medical Device (SiMD) and standalone software (Software as a Medical Device (SaMD)), specifically related to definitions, classification and cybersecurity.
Philippines FDA Announces New Fee Schedule for Medical Devices
/in Latest Updates, Philippines/by Charmaine RosonOn November 29th and 30th the Philippines FDA hosted a public forum to review and field questions on plans to change the fee schedule for processing registration applications as outlined in a recent draft Administrative Order (available here) and it’s corresponding Annexes.
MDD Issues Guidance on Making Changes to Medical Device Licenses in Hong Kong
/in Hong Kong, Latest Updates/by Albert PranotoOn November 30th, the Hong Kong Medical Device Division (MDD) issued formal guidance on the requirements to make changes to medical device licenses registered in the Medical Device Administrative Control System (MDACS).
CDSCO Issues Updates to IVD Classification List in India
/in India, Latest Updates/by Gunjan VermaThe Central Drugs Standard Control Organisation (CDSCO) of India issued a notice (PDF) on October 25, 2023 classifying in-vitro diagnostic (IVD) medical devices under medical device rules. The updates to IVD classification in India include intended use, associated risk, and other parameters.
Embracing Innovation and Collaboration: Highlights from the 15th CII Global MedTech Summit
/in India, Latest Updates/by Gunjan VermaOn October 6, 2023, a team of enthusiastic members from the AAI (Artificial Intelligence and Innovation) group, including Ashoniya Puri, Sanjay Singh, and Rajat Budhori, had the honor of attending the prestigious 15th CII Global MedTech Summit. Hosted by the Confederation of Indian Industry (CII), one of India’s largest industry bodies, this event brought together key players in the MedTech sector, both from India and abroad. The summit revolved around the central theme, “Paving the way for a USD 50 billion MedTech Industry by 2030,” signifying a collective vision for the industry’s future growth.
Bangladesh LAUNCHES NEW MEDICAL DEVICE REGULATIONS
/in Bangladesh, Latest Updates/by Albert PranotoOn September 18, 2023, The Directorate General of Drug Administration (DGDA) published the Drug and Cosmetics Act 2023 formalizing the regulatory requirements of medical and diagnostic devices in Bangladesh with immediate effect. A translated version of the document is available on Asia Actual’s website here. All medical devices now require a Marketing Authorization Certificate to clear Customs and be sold on the market in Bangladesh.