Dear APACMed Members, We hope you are doing well during these challenging times. We are delighted to bring you the March 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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| Regulatory Updates from Asia Pacific Markets |
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Australia
On 18th February, TGA issued Notice on Regulation of Software Based Medical Devices. This guidance provides a summary of changes to the regulation of software based medical devices (including software as a medical device - SaMD) that take effect from 25 February 2021. It outlines transition arrangements available for devices that may need to be reclassified or that qualify for an exemption or exclusion from regulations. This notice informs that Governor-General in Council has made regulations which delay the commencement of a number of medical device reforms in Australia. This delay reflects the challenges identified by the medical devices industry and healthcare professionals to redirect their efforts to regulatory changes as they have focussed on the COVID-19 crisis. The delay will allow additional time for the Therapeutic Goods Administration (the TGA) to further consult with the medical device industry and health care professionals on guidance material and implementation details relating to the reforms.
To understand the actual and possible risks of harm from software, a rapid literature review was undertaken. The review considered articles and papers published over the last seven years that specifically addressed safety and efficacy, including mobile apps and medical software more broadly. Many of the studies cited in the review relate specifically to challenges with SaMD, and software controlling medical devices, however some additional reports of safety and performance issues with medical software have also been included for context.
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China
On 12th March, NMPA issued Notice on Medical Device Master File Registration Items and Interpretation guidance. NMPA has established a medical device master files registration platform and database and published the relevant registration items and interpretation document of medical device master files reference, global practice, to build master file to accelerate and improve registration. Master file owner can volunteer submit raw material or other information to CMDE. Registration applicant (also called legal manufacturer) take full responsibility for medical device will sign agreement with master file owner to get authorization to use their master file for registration. It will avoid dossier duplication submission and review to improve MD review and approval processes. |
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India
On 5th February, MOHFW issued Notification GSR 98(E) on Draft Medical Devices (Amendment) Rules, 2021. CDSCO published these draft rules to amend the Medical Devices Rules 2017 to include reference of American Standard Test Method (ASTM) in addition to ISO/IEC for Medical Devices. These draft rules shall be taken into consideration on or after the expiry of a period of forty-five days from date of notification. |
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Japan
Following are the main mandatory requirements- - Upload all of existing product IFU into PMDA website before August 1
- Need GS1-128 code on the product package
- link between GS1128 code and IFU at PMDA website
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Philippines
This Circular informs that to guide the local manufacturer, importer and/or distributor of the product standards to refer to and comply with prior to applying for a Certificate of Medical Device Notification (CMDN) or Certificate of Medical Device Registration (CMDR) for their medical device product, the following hierarchy of product standards shall apply: - Philippine National Standard (PNS)
- ISO standard or IEC standard (whichever is applicable) in the absence of PNS.
- Standard developed by other International Standard Bodies recognized by the DOH in the absence of PNS, ISO Standard and IEC standard
- Any foreign standard that may be recognized by the DOH for the purpose of registration in the absence of PNS, ISO Standard, IEC standard and standard developed by other International Standard Bodies recognized by the DOH.
All medical devices either imported or locally manufactured that do not comply with any of the above specified standards shall not be issued with CMD or CMDR. |
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Singapore
On 1st March, Health Sciences Authority (HSA) issued Guideline: GN-IOCTB-03-002: Clinical Trials Guidance – Clinical Research Materials. This document provides guidance to local manufacturers, importers and suppliers on the regulatory requirements relating to the import and supply of clinical research materials (CRM). Suppliers include importers, local manufacturers, wholesalers, sponsors, investigators and any persons who supply CRM. This Guidance is organised into two sections: CRM notification process and duties and obligations of local manufacturers, importers and suppliers of CRM. |
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South Korea
On 22nd February, MFDS released the Notification No. 2021-10: Establishment of Provision on Operating Preliminary Review for Medicinal Products. The purpose of this document is to support the early entry of medical products into the market by setting up a preliminary review system that allows an applicant to request a preliminary review request to the Minister of Food and Drug Safety regarding the data necessary for product approval, notification, certification, or approval of a clinical trial plan in accordance with Article 35-2 of the Pharmaceutical Affairs Act (IDRAC 289578), Art. 3 of Advanced Regenerative Medicine and Advanced Biopharmaceutical Safety and Support Act (IDRAC 318077), Art. 11 of Medical Device Act (IDRAC 309165) and Art. 4 of In Vitro Diagnostic Devices Act (IDRAC 294089). In addition, the provision supports rapid commercialization of innovative medical products that converged and applied the prevention and treatment of life-threatening infectious diseases or advanced IT and BT new technologies. Accordingly, by integrating regulations related to pre-review of pharmaceuticals and medical devices, etc. which are operated as separate regulations, the necessary matters for pre-review targets and treatment procedures are defined. The objective of this provision will be to lead the rapid commercialization of medical products, including infectious diseases prevention and treatment agents, and to contribute to the protection of national health rights. On 23rd February, MFDS released the Notification No. 2021-11: Provision on Items and Item Classification for In Vitro Diagnostic Devices. The purpose of this document is to establish in vitro diagnostic devices legislation in accordance with In Vitro Diagnostic Devices Act, and define the criteria for classification of in vitro diagnostic medical devices items and the data to be submitted when applying for reclassification of items. In the any of the following cases, a product license must be reissued with the item name changed- 1) J08040.01 J11010.01 Diabetic disease-related test reagent certified as a clinical chemical enzyme test reagent 2) Major category (J) J20030.01 Other clinical chemistry test strip I, J20030.02 Other clinical chemistry test strip Ⅱ, J20030.03 Other clinical chemistry test strip Ⅲ 3) P04010.02 Cellular tissue pathology diagnostic aid software licensed as P04010.01 pathological tissue diagnostic aid software
On 26th February, MFDS released the Notification No. 2021-15: Establishment of Special Provisions for Approval of Innovative Medical Devices. The Purpose of this provision is to stipulate details of the step-by-step review for innovative medical devices, the procedures and methods of priority review, and the range of data that can be exempted when a medical device software manufacturer applies for a manufacturing license or manufacturing certification. It addresses the scope of data to be submitted for the step-by-step review, procedures and results notification method for a medical device designated as an innovative medical device and how to apply for expedited review and exemption range of submitted data for approval of innovative medical device software. |
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Taiwan On 4th February, MOHW released Announcement No.1091613266: Soliciting Public Comment on Clinical Trials for Non-significant Risk Medical Devices (Draft). This regulation is established based on Article 37, Paragraph 1 of Medical Care Act. It is developed to define the conditions of exempting the application of review and approval on the Clinical Trials conducted for Non-significant Risk Medical Devices. This document aims to solicit public comment on the issues related to Clinical Trials for Non-significant Risk Medical Devices. In this document, it lists the conditions of exempting the application of review and approval of medical device clinical trials. Deadline for comment: within 60 days.
On 9th February, MOHW issued Order No.1101660674: Regulations Governing the Application of Specific Medical Technique and Medical Device. This regulation is established based on Article 62, Paragraph 2 of Medical Care Act (IDRAC 308018). The main content is to regulate the registration applications of 20 types of specific medical devices and the technical inspections on practice or usage of these medical devices. This regulation will come into force since the date of publication. This document replaces MOHW Order No.1071665803: Regulation on Specific Methods for Inspection on Medical Devices, 06-Sep-2018 (IDRAC 288200) and Regulation: Regulation on Technical Inspection on Practice or Usage of Specific Medical Devices, 09-Dec-2016 (IDRAC 243988). |
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APACMed Regulatory Intelligence Editorial Committee Miang Tanakasemsub (Cardinal Health), 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), Seungmi Han (Roche), Shivkumar Hurdale (Stryker), Leslie Kim (Stryker), Juliana William (Baxter), Rhoel Laderas (Baxter), Shiho Tanaka (JNJ), Desmond Pung (Roche), Asok R. Kumar (Abbott), Silvia Burelli (Lima Corporate), Roberto Gabetta (Lima Corporate).
Data powered by Cortellis Regulatory Intelligence, a suite of intelligence offerings from Clarivate. Please click here to find out more.
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