We are delighted to bring you the January 2021 issue of the Asia Pacific MedTech Regulator

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Dear APACMed Members,  
 
We hope you are doing well during these challenging times. 
 
We are delighted to bring you the January 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
Updates from APACMed
On 28th January, APACMed Digital Health Committee released a white paper on Digital Health Regulation in Asia-Pacific: Overview and Best Practices. Since, regulatory bodies across the world struggle to stay up with the rapid transformation of healthcare, a major challenge being that digital health is included under the medical device umbrella. This Paper, written in partnership with A*STAR’s Diagnostics Development (DxD) Hub, highlights the unique features needed for Digital Health regulations and aims to lead toward the creation of a fit-for-purpose regulatory framework for Digital Health across APAC.
Regulatory Updates from Asia Pacific Markets
Australia

On 21st December, Notice on Improving Post-Market Monitoring and Surveillance of Medical Devices was issued to inform that few concerns have been raised on how TGA identify and assess problems occurring with medical devices across Australia. On different inquiries around post-market surveillance and monitoring, it recommended the TGA to:
  • improve the level of data capture relating to adverse events
  • adopt a more systematic and transparent approach to risk assessment of adverse events
  • enhance the methods of identifying cases and strengthen methods of prioritising cases
  • identify and document key issues- underlying decisions made by the regulator
 
China

On 26th November, CMDE released a notification on Technical Guidelines in Using Overseas Clinical Trial Data in In-vitro Diagnostics (Draft) and Soliciting Public Comment. The documentincluded the draft of Technical Guidelines in Using Overseas Clinical Trial Data in In-vitro Diagnostics and CMDE now solicits public comment on this draft. The deadline for comments were by 15-Dec-2020 and the technical guidelines have the following parts:
  • Scope
  • Key considerations of the difference between overseas and domestic clinical trials
  • Dealing with the differences
  • Dossier requirements of using overseas clinical trial data

On 31st December, NMPA released Notice No.2020/147: Adjusting Some Contents of the Classification Catalogue of Medical Devices. This document issues the newly approved medical device industry standard: No.2020/147 Adjusting Some Contents of the Classification Catalogue of Medical Devices. The coming-into-force date is 31-Dec-2020.

On 11th January, NIFDC released a Notice: Soliciting Opinions on the Recommended National Standard (Exposure Draft) of the Medical Devices-quality Management Systems-Requirements for Regulatory Purposes. This document includes Medical devices-Quality Management Systems-Requirements for Regulatory Purposes (Exposure Draft), and Preparation Instructions of National Standard Medical Devices-Quality Management Systems- Requirements for Regulatory Purposes (Exposure Draft). NIFDC now solicits public comment on the draft. Deadline for comment: 8-Mar-2021.

On 12th January, Shanghai Municipal Medical Products Administration, Shanghai Municipal Healthcare Security Administration, and Shanghai Municipal Health Commission issued Notice: Issuance of Shanghai Whole Area Pilot Work Plan for Joint Promotion of Unique Device Identification System. This document issues the newly approved regional standard: Issuance of Shanghai Whole Area Pilot Work Plan for Joint Promotion of Unique Device Identification System. The coming-into-force date is 12-Jan-2021.

On 19th January, State Food and Drug Administration released Announcement No.2021/3: Issuing the Catalogue of Medical Devices Exempt from Clinical Trials (Second Batch Revision). This document issues the newly approved medical device industry standard: No.2021/3 Catalogue of Medical Devices Exempt from Clinical Trials (Second Batch Revision) The coming-into-force date is 19-Jan-2021.
 
Japan

On 21st December, MHLW issued Basic Concept on The Utilization of Registry in Application for Approval, etc. (Draft), Points to Note for Ensuring Reliability when Using Registry Data for Approval Applications, etc. (Draft). This is the draft guidance of RWE, when we use registry data for pre-market submission. It is included 'basic concept' and 'consideration points of data quality'. These documents are summarized current PMDA review policy.
 
On 25th December, MHLW issued the Ordinance on Partial Revision of Ordinances Concerned by the Ministry Of Health, Labour and Welfare For Reconsidering Seal Requirement, (IDRAC 323158). This ministerial ordinance is aimed at deleting 'company seal' requirements for each relevant format, as part of the current government’s reforms after COVID-19. Until now, As Japan regulation and customs, usually the process of doing stamp 'company seal' near company name was performed while submitting the official documents. With this notification, the seal is no longer required.
 
On 25th December, MHLW issued the Ordinance No. 208/2020 on Partial Revision of Ordinances Concerned by the Ministry of Health, Labour and Welfare for Reconsidering Seal Requirement. This ministerial ordinance is aimed at deleting 'company seal' requirements for each relevant format, as part of the current government’s reforms after COVID-19. Until now, As Japan regulation and customs, usually the process of doing stamp 'company seal' near company name was performed while submitting the official documents. With this notification, the seal is no longer required.
 
Philippines

On 4th January,FDA released Circular No. 2021-002: Full Implementation of AO 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”. The document defines the guidelines covering the full implementation of medical device requirements, classification, and registration. Key points are as below:
  • CDRRHR shall be accepting applications for CMDN for Class B, C and D medical devices that are not included in Annex A of FDA Circular No. 2020-001.
  • Shall follow the existing procedure for filing of application for CMDNN for Class A medical devices.
  • CMDN for Class B, C and D medical devices will have a validity for two (2) years
  • Company shall apply for a CMDR three (3) months prior to expiration of the CMDN.
  • Classification that are not included in Annex A of FDA Circular No. 2020-001 and its amendment(s) shall follow the classification rules of AMDD as stated in item 2, Section V. General Guidelines of AO 2018-0002.
  • Legal and Technical requirements specified in Annex A and Annex B respectively of AO 2018-0002 shall be submitted when applying for CMDN for Class B, C and
  • The fee for CMDN shall be 3,000.00 and 1% for Legal Research Fee (LRF).
  • The fee for the CMDR shall be in accordance with the existing fees during the time of application.
  • Effectivity: 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 office of the National Administrative Register
 
On 5th January, FDA released Circular No. 2021-001: Hierarchy of Product Standards for Medical Devices to be Complied with for Notification/Registration Purposes. The document provides that 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. Hierarchy of product standards as follows (the next product of standard shall be used in absence of the previous higher product of standard): 1. PNS 2. ISO or IEC 3. Standard by other International Standard Bodies recognized by DOH 4. Any foreign standard that may be recognized by DOH. This order shall take effect immediately and shall remain valid unless otherwise revoked, repealed, or rescinded.
 
On4th January, FDA releasedCircular No. 2021-001-A: Amendment to Annex A of FC 2020-001 re: Initial Implementation of Administrative Order No. 2018-0002 “Guidelines the Issuance of an Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements. This circular provides Clarification of classifications and updated list of medical devices required to be registered with the FDA Effectivity: 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 office of the National Administrative Register.
 
On 15th January, FDA announced Re-Launching of FDA Verification Portal. This means FDA will resume access to the FDA Verification Portal starting on 18th January 2021 at the FDA website. This will allow the public to view all the products registered with the agency.
 
Taiwan

On 24th December, MOHW released Announcement No. 1091610954: Guidance for Medical Software Classification (Revised Version). TFDA issued the revised version of Guidance for Medical Software Classification (IDRAC 254344), which contains the following chapters: 1. Preface 2. Scope 3. Classification Principles of Medical Software 4. Possible Forms of Medical Device Software 5. Product Description and Examples 6. Reference Sources. This document replaces TFDA Announcement No. 1041601608: Guidance for Medical Software Classification, 13-Apr-2015 (IDRAC 254344).
 
APACMed Regulatory Intelligence Editorial Committee 
Miang Tanakasemsub (Alcon), Renee Cotta (Boston Scientific), Yenny Anggoro (Stryker), Dacia Su (Abbott), Jane Lin (Johnson & Johnson), Roberta Sarno (APACMED), Anirudh Sen (APACMED), Cindy Pelou (APACMED), Anjali Barak (APACMED)

APACMed Regulatory Intelligence Working Group 
Asok Kumar Raghavan Nair (Abbott), Cerline Tsai (Abbott), Crystal, Fan Bu (Roche), Jon Wong (Ortho Clinical Diagnostics), Juliana, Kayla, Kirti, Muhammad Sohail (Fresenius), Rhoel, Shiho Tanaka, Shivkumar Hurdale (Stryker), Yap Ee Peng (Alcon)

Data powered by Cortellis Regulatory Intelligence, a suite of intelligence offerings from Clarivate. Please click here to find out more.

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