Jack Wong (Passion with Regulatory and Startups) ❤️

Guangdong Provincial People’s Congress issued the “Regulation on the Management of the Importation of Drugs and Medical Devices from Hong Kong and Macao into the Nine Mainland Cities of Greater Bay Area” on July 31, 2024, signing the policy into law. The decree will take effect on December 1, 2024. A key change in the document is the availability of Real-World Study (RWS) in GBA. Previously, RWS can only be used in Hainan. Article 23 in the new regulations says that designated medical institutions in GBA are encouraged to collaborate with manufacturers to conduct real-world studies. The data from these studies can support for registration and marketing in mainland China. 🔎 Click the link to learn more details https://lnkd.in/eBjfFzha    We take immense pride in showcasing our recent achievements:  🎯 Approval of Class III Glaucoma Treatment Implants: In collaboration with a global frontrunner in ophthalmic diagnostic and treatment products, we secured China NMPA approval for their Class III glaucoma treatment implant devices. Despite facing significant challenges during the approval process with the China NMPA, our strategic acumen and expertise enabled us to utilize foreign clinical data and avoid local clinical trial as well as shorten the testing time to waive certain custom tests.    🎯Approval of Class III Medical Aesthetic Energy-Based Devices: We obtained approval for Class III energy-based devices, three months ahead of the client’s expectation! We avoided local clinical trials, effectively addressed the new requirement of dose-effective relationships and overcame certain deviations from China technical standards.    🎯Approval of Class III Stereotactic Radiosurgery System: After switching to several local agencies during their multi-year registration process, our client found us through word of mouth. We helped the client fill the gaps and the technical testing and obtained the NMPA approval.    These are just a few examples of our success. At CMD, we’re dedicated to pushing boundaries and achieving excellence in the Medtech field.    If your devices are used in Hong Kong and Macau, and you want to clinically use them in Guangdong, please contact info@ChinaMedDevice.com to chedule a complimentary call with us if you have any questions.    Subscribe our NMPA news roundup https://lnkd.in/eG57rXq to follow updates.  #NMPA #Chinamarket #Regularyaffairs #Medicaldevice #IVDs #Urgentuse #policy #Guangdong #GreaterBayArea #GBA #RWS

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On May 11, 2024, China’s National Medical Products Administration (NMPA) released the Announcement on Rules for the Classification of Medical Device Products (hereinafter referred to as the Rules). The enforcement of the Rules will start from September 1, 2024. Background The Rules will replace the current version of the working procedures and requirements for the classification of medical devices,   stipulated in Document No. 127 of 2017. In recent years, the medical device industry has developed rapidly, which presented new challenges for classifying and managing medical devices, such as for responding to the public emergency incidents. The need to further optimize the process, requirements, and efficiency of classification work has become urgent. Therefore, the NMPA organized the revision of the Rules, also aimed at supporting some of the tasks assigned in the Opinions of the National Medical Products Administration on Further Strengthening and Improving the Classification Management of Medical Devices, namely, enhancing the quality and efficiency of classification determination work, and promoting the innovative development of medical devices. https://lnkd.in/gggZqxNs

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On May 11, 2024, China’s National Medical Products Administration (NMPA) released the Announcement on Rules for the Classification of Medical Device Products (hereinafter referred to as the Rules). The enforcement of the Rules will start from September 1, 2024. Background The Rules will replace the current version of the working procedures and requirements for the classification of medical devices,   stipulated in Document No. 127 of 2017. In recent years, the medical device industry has developed rapidly, which presented new challenges for classifying and managing medical devices, such as for responding to the public emergency incidents. The need to further optimize the process, requirements, and efficiency of classification work has become urgent. Therefore, the NMPA organized the revision of the Rules, also aimed at supporting some of the tasks assigned in the Opinions of the National Medical Products Administration on Further Strengthening and Improving the Classification Management of Medical Devices, namely, enhancing the quality and efficiency of classification determination work, and promoting the innovative development of medical devices. https://lnkd.in/gggZqxNs

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#HSA, Singapore: Guidance for Industry_Post-marketing Vigilance Requirements for Therapeutic Products and CTGTP (Oct. 2024) Summary of changes: - Updated submission processes for new safety information, updated reference #RMP and #RMP documents - Added new requirement on the provision of the 5-year submission schedule for #PBRER - Added required text for finalised artwork of all HSA-approved educational materials - Updated submission processes for post-registration #RMP obligations Read more @ https://lnkd.in/diSwB8Bn

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**Excited to announce the release of the guidance document by the Health Sciences Authority of Singapore!** 🎉 The document provides detailed instructions for TR-01: Contents of a Product Registration Submission for General Medical Devices, aligning with the ASEAN CSDT revision 3, March 2024. This is a pivotal resource for ensuring compliance and understanding the nuances of medical device registration. Professionals in the #medicaldevices and #regulatoryaffairs sectors will find this guide invaluable. It clarifies the required information for each section of the CSDT and the submission format. **Note:** This guidance is specific to general medical devices and does not apply to in vitro diagnostic medical devices. Stay informed and stay compliant! #HSA #regulations #mdr745 #eumdr

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Important Update for Medical Device Exporters: RCMC Issuance Clarification Background: - DGFT Public Notice No. 18/2023 dated June 23rd, 2023, introduced the Export Promotion Council (EPC) for Medical Devices as the designated body to issue RCMCs for specific medical devices (listed in Appendix 2T of FTP 2023). - The notice clarified that existing RCMCs issued by EEPC India would remain valid until their expiry. Current Situation and Resolution: - The newly established EPC for Medical Devices is yet to fully commence operations and integrate with the DGFT's Common Digital Platform for RCMC issuance. - This creates a challenge for exporters seeking benefits under RODTEP (duty drawback scheme) for medical devices, as a valid RCMC from the concerned EPC is mandatory. To address this issue, the DGFT has taken the following steps: 1. Temporary RCMC Issuance: Until the EPC for Medical Devices becomes fully operational, RCMCs can be obtained from either: - EEPC India (existing practice) - Any other concerned EPC for Medical Devices (to be specified) 2. Customs Acceptance: Customs authorities have been instructed to accept RCMCs for medical devices issued by either EEPC India or any other concerned EPC until further notice. What This Means for You: - Medical device exporters can continue applying for RCMCs through EEPC India or any other designated EPC (details to be announced). - Existing RCMCs issued by EEPC India remain valid. - Customs clearance for medical device exports will not be hindered due to the temporary issuance arrangement. #MedicalDevices #RCMC #DGFT #Exports #India #eepc #export

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🚩 Regulatory Update in Hong Kong! On March 28, 2024, the Medical Device Division (MDD) of the Department of Health in Hong Kong made a significant announcement on its website regarding the acceptance of marketing approvals acquired from the Health Sciences Authority (HSA) of Singapore under the Medical Device Administrative Control System (MDACS). Stay up to date with the latest regulatory updates at https://hubs.ly/Q02xgC_x0! Do you want to register your products in Hong Kong? With our cutting-edge regulatory affairs technology, you can start a device-specific registration in over 140 countries in less than a minute and have customized submission files and process management in less than five minutes. 👉 Find HK-specific regulatory information at https://hubs.ly/Q02xgD1g0. #ArazyGroup #RegTech #RegTechAI #RegulatoryAffairs #Medtech #RegUpdate #RegulatoryUpdate

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As announced in the 2024 Policy Address on 16 October, the Government will expedite the reform of the approval mechanism for drugs and medical devices. The measures include extending the "1+" mechanism to all new drugs and improving the approval mechanism to speed up registration, facilitating good drugs for use in Hong Kong; and devising the timetable for the Hong Kong Centre for Medical Products Regulation and the roadmap towards adoption of "primary evaluation", as well as formulating strategies and measures to facilitate research and development of drugs and medical devices. Furthermore, the Government will enhance Hong Kong's clinical trial capability on all fronts and facilitate the translation of innovative biomedical research results into clinical applications. The report, Developing Hong Kong into Asia’s Leading Clinical Innovation Hub, launched by 團結香港基金 Our Hong Kong Foundation, advocated the establishment of Hong Kong’s drug primary review authority and expediting drug registration and clinical trial approval with the NMPA to position Hong Kong as the “Super-connector” of drug development. Developing Hong Kong into Asia’s Leading Clinical Innovation Hub Full report: https://bit.ly/4dU0DUK #PolicyAddress #2024PolicyAddress # HealthandMedicalInnovation #TechnologicalInnovation

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Director of the Korea Disease Control and Prevention Agency: “Influenza will peak in 1-2 weeks… Antiviral drugs are sufficient” Ji Young-mi, Commissioner of the Korea Disease Control and Prevention Agency, announced that the influenza epidemic is expected to peak in one to two weeks. This prediction follows a significant rise in influenza-like illnesses, especially among school-age children and adolescents, reaching the highest levels since 2016. In the first week of January, suspected influenza cases surged to 99.8 per 1,000 individuals, representing a 1.4-fold increase from the previous week. Hospitalizations also rose sharply from 795 last year to 1,452 this year. Director Ji noted that while COVID-19 hospitalizations are increasing, there are no unusual outbreaks of human metapneumovirus or other infections. The Commission emphasized the importance of vaccination for vulnerable groups, including the elderly, pregnant women, and children under 12. Ji also urged adherence to respiratory infection prevention guidelines as the Lunar New Year holiday approaches. The government is prepared with sufficient antiviral drug supplies to ensure ongoing treatment for respiratory infections. #AsiaRisk #EpidemicsandPandemics #SouthKorea Get a full accounting of the security situation in Asia by subscribing to Security Asia. Subscribe now--free of charge--at Substack https://lnkd.in/gPtAUrsX https://lnkd.in/g3VAA7eX

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In late March, Singapore’s HSA promulgated a number of updates for the registration of drugs. First, from April 2024, the HSA will look at a pilot program to use e-labeling for pharmacy-only and generally listed therapeutic products – in addition to RX products that currently use e-labeling. Second, the HSA has tried to clarify the requirements for expedited review of minor variations for drugs. Soon, the HSA will initiate an online form to help direct applicants on the eligibility of this new minor variation program. To be considered for an expedited review, the drug must meet certain criteria: there should be no alternative medicine available in Singapore, it should be required for National procurement, and there must be an urgent need for it, among other considerations. Read more: https://lnkd.in/gD4jPHR7

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MFDS & HSA News!! (Clinical Trials for Machine Learning-enabled Medical Devices) Today (11-December) the Ministry of Food and Drug Safety (MFDS) of South Korea and the Health Sciences Authority (HSA) of Singapore have released "Guiding Principles for Conducting Clinical Trials for Machine Learning-enabled Medical Devices (MLMD)." This guidance addresses the unique challenges of conducting clinical trials for MLMDs, ensuring that such devices meet rigorous standards for safety, effectiveness, and ethical compliance. This document covers: • Recommends trial configurations, including randomization, control groups, and endpoints, ensuring robust and unbiased evidence for MLMDs' performance and safety. • Patient and test dataset selection it highlights the importance of representative patient populations and independent test datasets (separate from training datasets) for generalizable results. • Selection of Clinical Reference Standard and Interpretation of Clinical Data for novel MLMD use cases, including consensus-building among clinical experts. • Primary endpoint and results analysis it suggests performance indicators such as sensitivity, specificity, and predictive values to evaluate the effectiveness of MLMDs in clinical settings. For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us at MedBoard. #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #euivdr #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #eumdr #hsa #mfds #clinicaltrial

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Linking IT and OT systems in pharma boosts efficiency and drives growth. Singapore’s investments in digital transformation make it a key innovation hub. #pharma #digitaltransformation #innovation #medical #InformaConnectAcademy

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