We are pleased to present the November 2021 issue of Asia Pacific MedTech Regulatory Intelligence

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Dear APACMed Members,  
 
We are delighted to bring to you the November issue of the 2021 Asia Pacific MedTech Regulatory Intelligence Watch steered by our Regulatory Intelligence Working Group in partnership with Cortellis. 
 
The objective of this Watch, is to provide our members with up to date regulatory briefs and actionable insights which can contribute to key regulatory decision making processes for all markets across Asia Pacific. 
 
Sincere thanks to the Editorial Committee and the Working Group for all their contributions.
 
Please feel free to reach out to us directly for any further information or questions.                  
 
Best wishes, 
APACMed Secretariat
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Australia
Guideline: Medical Device Patient Information Leaflets and Implant Cards, Including Acceptance of Implementation Plans, Version 1.7, Nov-2021.From 1 December 2021 all implantable and Active Implantable Medical Devices (AIMD) are required to have patient information materials available in the form of both Patient Information Leaflets (PILs) and Patient Implant Cards (PICs), unless specifically excluded from these requirements. PILs and PICs must meet the Essential Principles to be considered compliant.
 
Sponsors who will not have compliant patient information materials in place by 1 December 2021 will need to apply for consent to import, supply, or export a medical device that does not comply with the Essential Principles to ensure continuous supply of an affected device. This includes payment of application fees and the approval from the delegate of the Secretary. The application form is available on the TGA Business Services (TBS) portal.
China
NMPA Notification: Soliciting Public Comment on the Administrative Provision of Medical Device Adverse Events (AE) Surveillance and Re-evaluation (Amendment Draft) (Draft), 23-Nov-2021. NMPA published Administrative Measures for Monitoring and Reevaluation of Medical Device Adverse Event (Draft Amendment) (Exposure Draft) based on existing version implemented on Sep. 1 2019 to compliance NO. 739. Call for comment from industry by 22 Dec. 2021.
 
NMPA Announcement No.2021/91: Issuance of Two Technical Guidelines Including Technical Guidelines for Registration Review of Medical Device Clinical Trial Data Submission Requirements, 25-Nov-2021.To strengthen the supervision and guidance of medical device product registration, and to further improve the quality of registration review, the NMPA has organized and formulated the Technical Guidelines for Registration Review of Medical Device Clinical Trial Data Submission Requirements and Technical Guidelines for Registration Review of In-vitro Diagnostic Device Clinical Trial Data Submission Requirements. This document includes: 1. Technical Guidelines for Registration Review of Medical Device Clinical Trial Data Submission Requirements: Foreword, applicable scope, basic principles, submission format and drafting unit. 2. Technical Guidelines for Registration Review of In-vitro Diagnostic Device Clinical Trial Data Submission Requirements: Foreword, applicable scope, basic principles, clinical trial database related content requirements, submission format and drafting unit. 
 
CAC call for comments on Regulations on Network Data Security Administration (Exposure Draft), 14-Nov-2021.Cyberspace Administration of China has organized and formulated the “Regulations on Network Data Security Administration (Exposure Draft)” , which is soliciting public comments. Official deadline for CFC by 13th Dec. 2021.
India
Draft Policy to Catalyze Research & Development and Innovation in the Pharma- MedTech Sector in India. DOP issued a Draft Policy on 1 Nov to Catalyze Research & Development and Innovation in the Pharma- MedTech Sector in India. The aim of this policy is to simplify regulatory processes to enable rapid drug discovery and development and innovation in medical devices; incentivize private sector investment in research and evaluate various funding mechanisms and to identify mechanisms to strengthen the R&D ecosystem through increased collaboration between Industry and Academia.
 
Regulation of CT scan equipment, All Implantable Devices, MRI equipment etc. as Drugs with effect from April 1st, 2021.CDSCO issued a notice that after understating need of manufacturer and importer. It has been decided that in case an existing importer/manufacturer who is already importing /manufacturing any of those devices, and whose application has been submitted to the Central License Authority or State License Authority, as the case may be, for grant of import/manufacturing license in respect of the said device(s) under provisions of MDR, 2017 by 18.04.2021, the said application shall be deemed to be valid and the importer/manufacturer, can continue to import/manufacture the said device(s) up to 30.06.2022 or till the time the Central License Authority or State License Authority, as the case may be, takes a decision on the said application, whichever is earlier.
 
Order - Regulation of CT scan equipment, All Implantable Devices, MRI equipment etc. as Drugs with effect from April 1st, 2021- Regarding The Central Drugs Standard Control Organization vide order dated 03.11. 2021 has provided for Regulation of CT scan equipment, All Implantable Devices, MRI equipment etc. as Drugs with effect from April 1st, 2021 (read here). CDSCO, to ensure smooth transition, has also provided a relaxation to existing importer/manufacturer who is already importing /manufacturing any of those devices, and whose application has been submitted to the Central License Authority or State License Authority, as the case may be, for grant of import/manufacturing license.
 
Those application shall be deemed to be valid and the importer/manufacturer, can continue to import/manufacture the said device(s) up to 30.06.2022 or till the time the Central License Authority or State License Authority, as the case may be, takes a decision on the said application, whichever is earlier. In case the applicant has submitted an incomplete application (submitted by or before 18.04.2021), is required to ensure submission of all the necessary documents to the concerned Authority, by 31.03.2022.Central Licensing Authority or State Licensing Authority shall dispose of these applications within three months from the date of receipt of complete application.
Malaysia
Requirements for Labelling of Medical Devices, MDA/GD/0026, 4th Edition, Oct 2021.Additional labeling requirement on medical devices has been outlined in this latest guidance document. It also includes further details on the labeling FAQ which was published recently.
 
Conformity Assessment Procedures for Medical Device Approved by Recognized Countries. MDA has now added EU MDR and EU ICD as additional approval type issued by notified body. It has also accepted MHRA as one of its recognised foreign regulatory authority (circular).
Philippines
FDA Advisory No.2021-3084 Abridged Processing of Applications for Registration/ Notification of Medical Devices Approved by the Regulatory Authority of Any ASEAN Member Country.
  • The Food and Drug Administration (FDA) supports the implementation of good regulatory reliance practices for increased efficiency of regulatory systems which will result to faster access to safe, quality and effective medical devices.
  • In line with this and in consideration of the harmonized ASEAN Common Submission Dossier Template (CSDT) under the ASEAN Medical Device Directive (AMDD),
  • FDA shall have an abridged processing of application for registration/notification of medical devices approved by the Regulatory Authority of any ASEAN member country under the AMDD-CSDT requirements
  • The company still needs to submit all the legal and applicable technical requirements pursuant to Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements”.
  • The expedited review process shall take effect on 25 November 2021
South Korea
Guideline: Guide-0474-05: Guideline on Approval and Review of Epidural Catheter, 05-Nov-2021. The purpose of this document is to provide guidelines on technical document preparation for epidural catheter. The epidural catheter is a disposable catheter used to inject drugs to relieve pain outside the dura mater around the spinal nerve. Recently, as the functions of the epidural catheter have diversified. As an expandable balloon is mounted on the distal part of the catheter or as catheters with imaging modules (intra-body type medical cameras, etc.) are being released, approval/review guidelines have been prepared to present evaluation items to secure safety and performance. The revision brought change of title from ‘Permission and Technical Document Preparation Guidelines’ to ‘Guideline on Approval and Review’ and presentation of performance evaluation items for multifunctional epidural catheters.
Sri Lanka
Exemption of performance Clinical evaluation for Medical devices & IVDs. National Medicine Regulatory Authority (NMRA) has decided to use regulatory reliance principle and exempt the performance evaluation (Clinical evaluation/Sample Evaluation) for following general medical devices (Non IVD Medical Devices) and In-vitro diagnostics medical devices. The decision has been taken to expedite the registration process (notification).
 
In-vitro diagnostics medical devices. (New applications) approved by World Health Organization (WHO) or WHO reference regulatory authorities (Food and Drug Administration -USA, Therapeutic Goods Authority-Australia, Health Canada, Health Sciences Authority – Singapore and Ministry of Health, Labour and Welfare – Japan). One year provisional registration will be granted.
 
Covid -19 essential medical devices (New application of Non IVD Medical Devices) approved by one of NMRA reference country (USA, Australia, Canada, UK, Netherland, Japan, Denmark, Germany, Switzerland, Norway, Sweden, France, Italy). One year conditional provisional registration will be granted with pending performance evaluation.
 
Already registered / marketed General Medical devices (Non- medical IVDs) and in-vitro diagnostic medical devices (IVDs) which don’t have complaints/quality issues. (Renewal applications)
 
Extension of the period of validity of Import Licences which have the valid registration but have already expired or expire by December 31, 2021The NMRA, having considered the present situation associated with the Covid-19 pandemic, has decided to extend the period of validity of import licences which have the valid registration but have already expired or expire by December 31, 2021. Accordingly, the following information should be provided to the NMRA by email: mediext.nmra@gmail.com to extend the period of validity of import licenses.
 
Requirement criteria:
 You can apply via this route only for extension of the period of validity of import licenses which have the valid registration but have already expired or expire by December 31, 2021 (Already extended certificates of registration and import licenses will also be considered if they meet the required criteria). Import licenses will be extended according to the validity period of the registration certificates (validity period of the import license does not exceed the validity period of the registration). Validity extension is granted for a maximum period of one year.
Taiwan
MOHW Announcement No.1101609315: Technical Guidance on Reprocessing Single-use Medical Devices, 18-Nov-2021. MOHW released the revision of Technical Guidance on Reprocessing Single-use Medical Devices. The focus of this revision is to identify the four conditions of the single-use medical devices shall not be reprocessed and to update the referenced regulations.
Vietnam
Guideline: Reclassification of Medical Devices in Direct Contact with the Heart, Central Circulatory and Central Nervous Systems, Guidance on the Transitional Arrangements and Obligations, Version 1.1, Nov-2021. This guidance aims to assist sponsors of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) with meeting their obligations and outlines transitional arrangements to help comply with new regulations. From 25 November 2021 medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS)will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.
 
Decree 98/2021/NĐ-CP to manage Medical Device in Vietnam.
This Decree regulates the management: besides the control of MD’s classification; production, clinical research, circulation, purchase sale, export, import, information, advertising; the decree also control MD's price management and MD's use at medical facilities.
  • All MD companies/ Rep Office which are MD's Applicator can shelf declare the MD's Classification. MD Class A, B will be applied "Declare Applicable Standard". MD Class C, D will be applied "Registration Application"
  • New requirement for Clinical Trial. Local clinical Trial will be applied for local manufactured MDs.
  • Reference countries: US, Australia, Canada, Japan, EU countries, UK, Switzerland, China, Korea. (China and Korea are 2 new reference countries).
  • Fast track submission for MD class C, D: will be applied for MD having 1 FSC from reference countries or license in VN.
  • Emergency submission for MD class C, D: will applied for MD fighting pandemic, disasters and these MD belongs to the MD List approved by MOH AND being ranted with FSC or emergency approval by 1 referencing countries/ Belongs to emergency use products announced by WHO/ Belongs to popular products announced by Health Security Committee EUHSC/ have been granted with registration number or import license/ is domestically manufactured under technology transfer applicable to MD under points above
  • MD advertisement: owners must make public on e-portal of MD management: effective from 1st July 2022.
  • ASEAN common submission document templates (CSDT) shall be applied from January 1, 2023.
  • Declaration of prices of medical equipment: Name; Origin, Cost of imported medical equipment or production cost of domestically produced medical equipment; Expected profit; The maximum selling price of medical equipment corresponding to each configuration, technical features in units of calculation; Prices of components and accessories (if any); Cost of warranty, maintenance and maintenance (if any); Training costs (if any); Other expenses (if any); Timeline to complete Declaration of MD's price: before 1st April 2022.
  • The Decree is effective from 1st Jan 2022.
  • Transition time: MD Class C, D, MD with Import License can be imported until 31st December 2022.
 
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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