We are delighted to bring you the February 2021 issue of the Asia Pacific MedTech Regulato

If you can't see this email click here. Dear APACMed Members,     We hope you are doing well during these challenging times.    We are delighted to bring you the February 2021 issue of the Asia Pacific MedTech Regulatory Intelligence Watch.    The objective of the Watch, brought to you by our Regulatory Intelligence Working Group, in partnership with Cortellis, is to provide APACMed members with timely regulatory updates and actionable insights for markets across Asia Pacific.    Sincere thanks to the Editorial Committee and Working Group for their contributions to this newsletter. Please feel free to reach out to us directly for any further information or questions.           Best wishes,  APACMed Secretariat Regulatory Updates from Asia Pacific Markets China On 25th January, NIFDC released Letter of Chinese Academy of Inspection and Quarantine on Soliciting Proposals for Project Setup of Standards in the Field of Artificial Intelligence Medical Devices in 2022. This document includes Administrative Specifications for the Formulation and Revision of Medical Device Standards. Chinese Academy of Inspection and Quarantine now solicits Proposals for Project Setup of Standards in the Field of Artificial Intelligence Medical Devices in 2022. Deadline for proposal: 31-Mar-2021.   On 26th January, NIFDC issued Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 2-081: Special Requirements for Automatic and Semi-automatic Equipment for Analysis and Other Purposes in Laboratories (Draft for Comments). This document includes the draft and draft instructions of Special Requirements for Automatic and Semi-automatic Equipment for Analysis, and of Biological safety cabinet. NIFDC now solicits public comment on the draft. Deadline for comment: 15-Mar-2021. On 28th January, Guangdong Drug Administration released a Notice of Drug and Medical Device Regulatory Innovation and Development Work Plan in Guangdong-Hong Kong-Macao Greater Bay Area. This document includes the newly approved regional standard: Drug and Medical Device Regulatory Innovation and Development Work Plan in Guangdong-Hong Kong-Macao Greater Bay Area. The coming-into-force date is 28-Jan-2021. On 2nd February, NMPA issued Illustration policy - 2021 NMPA objectives and priorities including drug and MD. On 2nd February, NMPA issued 2020 Annual Report Illustration policy - 2020 NMPA summary. On 4th February, National Health Council issued the Administrative Measures for the Clinical Use of Medical Devices (No. 8 of the National Health Commission). This document includes the newly approved national standard: Administrative Measures for the Clinical Use of Medical Devices (No. 8 of the National Health Commission). The coming-into-force date is 1-Mar-2021.   On 5th February, NMPA published 2020 Medical device registration annual report. This report provides overview of 2020 MD registration including emergency approval for response to epidemic, reform review and approval system with updating MAH, UDI, standards, supervision etc. Also review and analysis registration submission & approval via different dimension such as domestic/import, MD/IVD. Singapore The Health Sciences Authority (HSA) introduced a new category of health products to be regulated under the Health Products Act (Chapter 122D) Cell, Tissue and Gene therapy products (CTGTP) Regulation 2021. The regulations will take effect on 1 March 2021. Classification of CTGP products and other information can be found here. South Korea On 6th January, MFDS released the Guideline SOP on Handling Medical Device Safety Information, such as Side Effects, Etc. This guideline was prepared in a form of instructions for officials use to facilitate predictable, transparent and consistent internal work processes related to safety information, such as reported adverse events resulting from use of medical devices. This revision focused on reflecting changes brought by revised Prime Minister Ordinance No. 1658: Enforcement Regulations (ER) of the Medical Device Act, 04-Dec-2020 (IDRAC 322140). The guideline is composed of the following sections: Purpose Legal Basis Terminologies Management System of Medical Device Safety Information Measures for Safety Information, such as Side Effects Attachments 1-6  This document replaces Guideline: Instructions-0180-03: SOP on Handling Medical Device Safety Information Such as Side Effects, Etc., Revision, 08-Oct-2020 (IDRAC 319088).  On 7th January, the List of COVID-19 In Vitro Diagnostic Devices Officially Approved by MFDS. This document presents list of COVID-19 in-vitro diagnostic devices approved by MFDS for domestic use. COVID-19 in vitro diagnostic devices have been approved through official regulatory pathway, not through the EUA process. The list is updated regularly. The last update added 1 item to the list. The update from 27-Nov-2020 added 2 items. The update from 10-Dec-2020 added 1 item. The update from 17-Dec-2020 added 1 item. The update from 24-Dec-2020 added 1 item. The update from 07-Jan-2021 added 1 item. The list contains 14 products.  On 7th January, List of COVID-19 In-vitro Diagnostic Devices for Export Only Approved by MFDS. This document presents list of COVID-19 in-vitro diagnostic devices approved by MFDS. The list is updated on a regular basis. The revision from 30-Oct-2020 added 8 items, including SGTi-flex COVID-19 & Flu A/B Ag DUO by Sugentech, Inc. The revision from 06-Nov-2020 added 5 items. The revision from 13-Nov-2020 added 5 items. The revision from 19-Nov-2020 added 6 items. The revision from 27-Nov-2020 added 6 items.  The revision from 11-Dec-2020 added 5 items. The revision from 18-Dec-2020 added 3 items. The revision from 24-Dec-2020 added 6 items. The revision from 31-Dec-2020 added 5 items. The revision from 07-Jan-2021 added 1 item. The list contains 241 items.    On 12th January, MFDS released Guideline (Instructions-0979-02) Instructions for Handling Medical Device Overseas Safety Information. The purpose of these instructions is to present procedures and standards to the public officers, so that necessary measures such as rapid collection, analysis, etc. of medical device overseas safety information can be performed efficiently and consistently. The document is composed of the following sections: General Considerations Handling of Medical Device Overseas Safety Information Work Procedures for Medical Device Overseas Safety Information Appendices 1-10. The revision added measures related to overseas safety information of medical devices and administrative dispositions when not respected.   This document replaces Guideline: Instructions-0979-01: Instructions for Handling Medical Device Overseas Safety Information, 12-Oct-2020 (IDRAC 319916).  On 12th January, MFDS released the Document for Public Comment (MFDS Announcement No. 2021-011): Administrative Advance Notice on Partial Amendment of Provision on Items and Item Classification for In Vitro Diagnostic Devices (Draft). The purpose of this document is to solicit public comments on MFDS Notification No. 2020-34: Provision on Items and Item Classification for In Vitro Diagnostic Devices, 01-May-2020 (IDRAC 311410). The purpose of the proposed revision is to improve efficiency in the safety management of in vitro diagnostic medical devices by improving the problems of classification of current in vitro diagnostic medical devices discovered in the process of in vitro diagnostic medical device approval, review, and application handling. The draft proposes: Establishment of 4 subcategories of in vitro diagnostic medical device items Changes to the definitions of 33 in vitro diagnostic medical device items   On 21st January, MFDS released an Approval and Review Guideline for COVID-19 In Vitro Diagnostic Medical Devices (Guide-1023-04). The purpose of this guideline is to assist with the approval application and application review as a reference for preparing the required application and submission data for the in vitro diagnostic medical devices used to diagnose COVID-19, a respiratory syndrome caused by infection with SARS-CoV-2 and it is 3rd revision. This revision is to reflect additional performance standards for new samples and RWD acceptance plan for emergency use approved products. Taiwan On 29th January, MOHW released Order No.1091107861: Regulation for the Inspection of the Medical Device Good Distribution and Distribution Licenses. The GDP regulation requirement is finally released. It will be implemented per product classification (risk level) as defined by TFDA and the implementation date will be announced. Thailand On 15th February, Thailand issued 11 new regulations, which are divided into 3 groups: Ministerial Regulation (4 regulation) which cover the new requirement for product registration and registration fee: Ministerial Regulation on Licensing for Manufacturer or importer of Medical Device. The Effective date: 15 Feb 2021 Ministerial Regulation on Notification for manufacturer or importer of Medical Device. The Effective date: 15 Feb 2021 Ministerial Regulation on Listing for Manufacturer or Importer of Medical Device. Effective date: 17 March 2021. Ministerial Regulation on Registration Fee. Effective date: 17 March 2021.  Note: Licensing is referring for Products under Class 4 (higher risk) Notification is for products under Class 2 and 3 Listing is for products under Class 1 Notification of the Ministry of Public Health (3 notification): - Notification of the Ministry of Public Health on groups of Medical Device or Medical Device that manufacturer or importer must be licensed. Effective date 15 Feb 2021. Notification of the Ministry of Public Health on groups of Medical Device of Medical Device that manufacture, or importer must be notified. Effective date: 15 Feb 2021 APACMed Regulatory Intelligence Editorial Committee  Miang Tanakasemsub (Alcon), Renee Cotta (Boston Scientific), Yenny Anggoro (Stryker), Dacia Su (Abbott), Jane Lin (JNJ), Anirudh Sen (APACMed), Anjali Barak (APACMed) APACMed Regulatory Intelligence Working Group  Cerline Tsai (Abbott), Crystal Nie (JNJ), Fan Bu (Roche), Jon Wong (Ortho Clinical Diagnostics), Kayla Thum (Resmed), Muhammad Sohail (Fresenius), Shivkumar Hurdale (Stryker), Yap Ee Peng (Alcon), Sahjogita Kathuria (Terumo), Juliana William (Baxter), Jacqueline Monteiro (Abbott), Lynn Tseng (Hologic), Ping Wang (Resmed), Leslie Kim (Stryker), Seungmi Han (Roche) Data powered by Cortellis Regulatory Intelligence, a suite of intelligence offerings from Clarivate. Please click here to find out more. Powered by Glue Up All-in-one CRM Software for Growing Communities