Dear APACMed Members, We hope you are doing well during these challenging times. We are delighted to bring you the July 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 |
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On 30th June, TGA issued a Guidance: Custom-Made Medical Devices; Information for Sponsors, Health Professionals & Manufacturers. The way that custom-made medical devices are regulated has changed. On 25 February 2021 a new framework for regulating personalised medical devices commenced. The framework includes a new definition for custom-made medical devices. The impact of the new definition is the majority of devices previously supplied under the exemption for custom-made medical devices no longer meet the definition of a custom-made medical device and will need to be included in the Australian Register of Therapeutic Goods (ARTG). If a device you manufacture or import is impacted by this change and requires inclusion on the ARTG, there are transition arrangements in place until 1 November 2024 to allow sponsors and manufacturers to complete this process. To access the transition period,sponsors will need to register using the online form before 25 August 2021: NOTIFICATION FORM: Transition arrangements for custom-made medical devices. Sponsors and manufacturers of custom-made medical devices need to comply with standard regulatory requirements including: - Ensure the custom-made medical devices they supply conform to all applicable Essential Principles;
- Meet the ongoing responsibilities of a sponsor including ensuring advertising compliance and reporting adverse events; and
- Comply with all other relevant regulatory requirements (for example, providing patient information leaflets and implant cards for all implantable medical devices).
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On 24th June, NMPA Notification No.2021/42: Technical Guidelines on Vision Screening Devices and Technical Guidelines on Breast Cancer X-ray System was released. CMDE has called for comments about technical guidance of Vision Screening Devices and Technical Guidelines on Breast Cancer X-ray System.
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On 30th June, Notice: PMDA/EM: Online Submission of the Reports and Notifications was released. PMDA will start online submission from July 1st, 2021. This first phase submission is acceptable only for 'notification'. It means, not necessary any user is fee. For example, change notification, etc. This submission will be used by 'FD submission application'. |
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Show Cause Notice: Suspension/ Cancellation of conventional disposable syringes (2, 2.5, 3 AND 5ML) was released. In line with the recommendations of Task Force on Injection Safety and the endorsement of the Policy Board of Drug Regulatory Authority of Pakistan, the Medical Device Board in the larger public interest has decided to issue show cause to 22 local manufacturers and states that why not stated Products (Conventional Disposable Syringes 2,2.5,3 & 5ml) be suspended/cancelled/deregistered. |
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On 24th June, Draft FDA Circular: Guidelines on the Licensing of Retailers of Medical Devices in the Philippines was released. The Circular provides guidance on the retail sale of medical devices in the country including non-traditional sources such as online and multimedia sites. The guidelines shall apply to the following retailers of medical devices:
- Retail stores for medical devices;
- Clinics that sell products classified as medical devices except those that are covered by the DOH One Stop Shop Licensing System;
- Sellers of online shopping website, social media platforms and/or TV shopping companies that sell or offer to sell medical device directly to the general public
- Operator of medical device vending machine
- Optical shops
- Drug outlets, such as drugstores, or boticas, and retail outlets for non-prescription drugs (RONPD) that also sell or offer to sell medical devices
In consonance with Administrative Order No. 2020-0017 (IDRAC 316022), this FDA Circular shall not cover grocery stores, supermarkets, convenience stores, chandler, kiosks and other similar stores. However, although these establishments are exempted from securing the LTO, they shall be held liable and shall be considered violating the FDA regulations if they sell or offer to sell unregistered/unnotified medical devices. This Circular shall take effect fifteen (15) days after its publication in a newspaper of general circulation and upon acknowledgement of receipt of a copy hereof by the University of the Philippines - Office of the National Administrative Register. Deadline for comments: 24-Jul-2021. All comments can be sent at mrsjyasona@fda.gov.ph with copy furnished to cdrrhr-prsdd@fda.gov.ph. |
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The APACMED Digital Health Committee would be providing feedback. For members with feedback, please provide feedback to rsarno@apacmed.org by 12th Aug 2021. |
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- Subjects of autonomous review of medical device advertisement (Art. 10-3)
- Procedures for autonomous deliberation and re-deliberation of advertisement (Art. 10-4)
- Composition of Autonomous Review Body (Art. 10-5)
- Designation and entrustment of duties of medical device integrated information center (Art. 10-6)
This document replaces Presidential Decree No. 30511: Enforcement Decree of Medical Device Act, 03-Mar-2020 (IDRAC 307199). This is a final version of a draft document MFDS Document for Public Comment: MFDS Announcement No. 2021-144: Legislative Advance Notice on Partial Amendment of Enforcement Decree of the Medical Device Act (Draft), 07-Apr-2021 (IDRAC 328079)." On 28th June, MFDS issued Notification No. 2021-53: Establishment of Provision on Recall and Disposition of Medical Devices. The purpose of this Regulation is to prevent harm to the public health by determining necessary contents for medical device recall, such as evaluation of the degree of medical device to be recovered, preparation and supplementation of the recall plan, how to publish a recall plan, period and notification of publication, action such as disposal, create a reclamation assessment report, reporting and confirming the end of the recall, reclamation result information disclosure, etc. The regulation provides information on the following contents:
- Creating recall plan (Art. 4 and Attached Table 1)
- Announcement of recall plan and duration (Art. 6 and Attached Table 2)
- Creating recall evaluation report (Art. 9 and Attached Table 3)
This is a final version of a draft document MFDS Document for Public Comment: Announcement No.: 2021-188: Administrative Advance Notice on Establishment of Provision on Recall and Disposition of Medical Devices (Draft), 30-Apr-2021 (IDRAC 329143). This guideline provides information on preventing foreign matter and defective products from occurring by analyzing the causes of foreign material mixing and defective products that may occur in each process, from raw material warehousing to process management, environmental management, and distribution. This is to minimize the mixing of foreign substances and defective products that may occur in the syringe by guiding the management method.
The guideline includes analysis of major cases and causes of syringes and defects. In addition, four key management factors that may arise from the following manufacturing processes are identified and detailed management items are introduced. - Raw material management
- Operator Management
- Environmental Management
- Process Management
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APACMed Regulatory Intelligence Editorial Committee |
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APACMed Regulatory Intelligence Working Group Cerline Tsai (Abbott), Crystal Nie (JNJ), Bu Fan (Roche), Seungmi Han (Roche), Leslie Kim (Stryker), Juliana William (Baxter), Wendy Lin (JNJ), Rhoel Laderas (Baxter), Shiho Tanaka (JNJ), Sahjogita Kathuria (Terumo), Deepali Deshmukh (Baxter), Cerline Tsai (Abbott), Wendy Lin (JnJ), Sylvia Ho (BSCI), Lynn Tseng (Hologic), Sinart Gearanantranon (JnJ), Kaiye Wang (Baxter), Jaclyn Teoh (Baxter)
Data powered by Cortellis Regulatory Intelligence, a suite of intelligence offerings from Clarivate. Please click here to find out more. |
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