Medical Devices – Asia and ROW Regulatory News – March 2023

JAPAN (PMDA)

Medical safety measures related to pharmaceuticals and medical devices

The Ministry of Health, Labor and Welfare is promoting various efforts to prevent medical accidents, but it is also possible to change the names, containers, and specifications of pharmaceuticals, medical devices, and other products used in medical settings to those that are less likely to cause medical accidents. The MOHLW believes that it will be one of the preventive measures, and we are proceeding with the construction of a system that will materialize.

Based on the discussions at this committee, MOHLW has decided to implement the following measures as measures to prevent medical accidents related to drugs and medical devices. 

About humanitarian clinical trials in Japan

The PMDA website will contain information on main clinical trials and humanitarian clinical trials (expanded clinical trials) submitted as clinical trial protocols to the PMDA. 
Information on main clinical trials and humanitarian clinical trials (expanded clinical trials) submitted to the PMDA as a clinical trial protocol is to be disclosed on the PMDA website.

Public information is as follows. This information will be updated by the end of each month.

• Main clinical trial information
• Information on humanitarian clinical trials (expanded clinical trials)
• List of Contact Information for Clinical Trial Notifiers

TAIWAN (TFDA)

Announcement the establishment of the “Guidelines for the Evaluation of Gender Differences in Clinical Trials of Medical Devices”

Announcement is established for the benefit of medical device manufacturers and research institutions, in the process of R&D, marketing and management of medical device products, it is appropriate to include gender differences in the recruitment of subjects, research design, statistical analysis, data interpretation and disclosure of research results in clinical trials. The content, etc. shall be considered, and supplemented as the basis or supporting information for the efficacy or safety of medical devices, and the announcement shall formulate the guidelines.

This case is also published in the announcement area and the medical device clinical trial area of the FDA’s global information.

Announcement to amend the “Standards of Administrative Fees for Medical Devices”

Amend the “Standards of Administrative Fees for Medical Devices”. With the revised “medical equipment administrative fee charging standard”

The fees payable for each of the following medical device application cases are as follows:

• Inspection and registration
• Changes and extensions of license registration items
• License collection, reissuance or renewal
• Registration, annual declaration and changes to registration items
• Clinical trials

Detailed info on Fees is in the link
https://www.fda.gov.tw/TC/newsContent.aspx?cid=3&id=28607

INDIA (CDSCO)

List of Notified Bodies registered with CDSCO under MDR, 2017

The notified bodies registered with CDSCO under provisions Medical device rules 2017 carry out audit of manufacturing site under the provisions of said rules. In this connection, following Notified bodies have been registered with CDSCO.

List of medical devices testing laboratory (MDTL) for carry out test or evaluation of medical device on behalf of manufacturer registered with CDSCO under MDR 2017 
The updated list of medical devices testing laboratory (MDTL) for carry out test or evaluation of medical device on behalf of manufacturer registered with CDSCO under MDR 2017 (Form MD -40).

SOUTH KOREA (MFDS)

MFDS supports export of medical devices beyond regulatory barriers with global leadership

The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea (Minister Oh Yu-Kyoung) attended the annual meeting of the Global Harmonization Working Party (GHWP*, Riyadh, Saudi Arabia) from February 13 to 16, where it strengthened global network for cooperation in the field of medical devices to take a main role for digital health and sought ways to support the export of domestic products.

In addition, with the experience and expertise of having the MFDS’ AI medical device guidelines adopted as international common guidelines during its chairmanship of IMDRF*, the MFDS began discussions at the GHWP on adoption of its ‘Guidelines on review and approval of AI-based histopathologic in-vitro diagnostic medical devices (software)’ as international common guidelines.

MALAYSIA (MDA)

CLASSIFICATION OF REHABILITATION, PHYSIOTHERAPY AND SPEECH THERAPY DEVICE 

This guidance document provides the classification of a list of products used for rehabilitation, physiotherapy and speech therapy by determining whether they are medical devices or non-medical devices based on their intended purpose as claimed by the manufacturer.

The definition of medical device is legally binding in the Medical Device Act 2012 (Act 737) and it determines the scope of regulatory control of the product. This definition differentiates medical devices and not medical device based on clear indication on mode of action for the product been used for rehabilitation, physiotherapy and speech therapy.

CHINA (NMPA)

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the registration review of two medical device products including dental adhesive products

This guideline applies to dental adhesive products for dental filling restoration and prosthetic restoration bonding. This guideline does not apply to products of special design and innovative design.

This guideline applies to artificial shoulder prostheses, which typically include humeral components (e.g., humeral head, humeral stem, humeral liner, humeral socket), glenoid components (e.g., glenoid liner, glenoid socket, glenoid head, fixation Screws), usually made of cobalt chromium molybdenum alloy, titanium alloy, ultra-high molecular weight polyethylene, ceramic materials. This guideline does not include the requirements for specially designed products such as patient-matched personalized artificial shoulder prosthesis, but the applicable parts can refer to the corresponding technical content in this guideline.

Notice on Soliciting Proposals for Pre-approval of Standards of National Medical Device Clinical Evaluation Standardization Technology Units in 2024
In accordance with relevant regulations such as the “National Standard Management Measures”, “Medical Device Standard Management Measures” and “Medical Device Standard Development and Revision Work Management Regulations”, in order to do a good job in the standard formulation work in 2024, we are now openly soliciting the 2024 medical device clinical evaluation field standard forecast Project proposal.

Clinical evaluation of medical devices (including clinical trials) and clinical trial quality management and general requirements for in vitro diagnostic reagents, excluding clinical evaluation requirements for specific products.

Timelines for additional medical device information are communicated by CMDE.

China’s Center for Medical Device Evaluation (CMDE) has published timelines for submitting additional information when a medical device supplementary information notice is issued. 

The timelines are as follows:

• The submission date is extended by one year for notices delivered before February 20, 2023.
• The submission deadline is reinstated to one year for notices issued starting on February 20, 2023.

Announcement of the State Food and Drug Administration, the National Health Commission and the National Medical Insurance Administration on Doing a Good Job in the Third Batch of Implementing the Unique Identification of Medical Devices
(2023 No. 22)

In order to further implement the “Regulations on the Supervision and Administration of Medical Devices”, the “Notice of the General Office of the State Council on Printing and Distributing the Reform Plan for the Treatment of High-value Medical Consumables” and the key tasks of the State Council to deepen the reform of the medical and health system, it is decided to use some second-class medical devices as the third The batches of varieties implement the unique identification of medical devices and the relevant matters.

SINGAPORE (HSA)

GL-08: Regulatory Guidelines for Laboratory Developed Tests (LDTs)

This document provides guidance and clarity in assisting clinical laboratories on understanding the regulatory requirements applicable to Laboratory Developed Tests (LDTs) under the Health Products Act 2007 (HPA) and Health Products (Medical Devices) Regulations 2010 (HP (MD) Regulations).

LDTs are in vitro diagnostics (IVD) that fall within the scope of the definition of medical devices stipulated under the first schedule of the HPA. This guideline is applicable to all LDTs (i.e. products including test reagents, and kits) developed within a licensed clinical laboratory solely for use within the same laboratory. This does not include test reagents and kits developed within a licensed clinical laboratory and distributed outside of the laboratory where it was developed as these will be regulated as commercial IVD products by HSA.

MEXICO (COFEPRIS)

Cofepris warns about counterfeiting of eight medical devices

The Federal Commission for the Protection against Sanitary Risks (Cofepris) informs health personnel, distributors and pharmacies of the public and private system, about the counterfeiting of eight types of medical devices of the brand Human Tech Spine GmbH.

Among the products marked as counterfeit are: implants for the thoracic and lumbar spine; screws, bars, hooks and bars for cross connector; and thoracic and lumbar interbody cages.

The irregularities that these fake devices present consist in the fact that they present a single color; They do not have visible engravings; the codes and names shown on the label are not part of the Human Tech product catalogue; the packaging is white on both sides; Lower quality texts, and the references do not exist in the manufacturer’s catalogue; Finally, they do not show the health registration number.

KAZAKHSTAN (NDDA)

Amendments have been made to the rules for assessing the quality of medicines and medical devices registered in Kazakhstan

This order introduced the definitions of a document confirming the quality of a batch of a medicinal product from a manufacturer and a document confirming the quality of a medical device.

Clarifications have been made regarding the provision of standard and specific reagents for testing, taking into account the verification of methods by the laboratories of an expert organization in the serial evaluation of medicines and medical devices, as well as in laboratory testing of vaccines.

Clarifications have also been made on the timing of the examination of documents and laboratory tests in the serial evaluation of medicines and medical devices and in the testing of vaccines, additional time is provided for additional tests in case of controversial test results.

The full text of the document can be found at the link: 
https://adilet.zan.kz/rus/docs/V2300031959#z7

PAKISTAN (DRAP)

SRO 224(I)/2023: Notification of Amendment in the Medical Devices Rules, 2017

The Drug Regulatory Authority of Pakistan is pleased to direct that the following additional amendments to the Medical Devices Rules, 2017, be made in accordance with the Federal Government’s approval, in accordance with the authority granted by section 23 of the Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012).

In terms of section 36 of the Drug Regulatory Authority of Pakistan Act,2012 (XXI of 2012) and from commencement of these rules, Medical devices be exempted from enlistment and registration requirements under these rules for a specified period mentioned in Notification

Proposed Amendments in the Rules: Stakeholders Comments are invited on Draft Amendments in the Drugs (Licensing, Registering & Advertising) Rules 1976 and the Medical Device Rules, 2017

The Draft of further amendment in the Medical Devices Rules, 2017, which is proposed to be made by the Drug Regulatory Authority of Pakistan, with the approval of the Federal Govemment, in exercise of the powers conferred by section 23 of the Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012), read with clause (a) of section 7 thereof, is hereby published for the information of a1l persons likely to be affected thereby and notice is hereby given that objections or suggestions thereon, if any, may be sent to the Drug Regulatory Authority of Pakistan within fourteen days of the publication of this Notification.

MALAYSIA (MDA)

NOTIFICATION OF CUSTOM-MADE MEDICAL DEVICE

This guidance document is intended to provide guidance for the requirements of custom made medical devices that are eligible to be exempted under Medical Device (Exemption) Order 2016. This guidance document specifies requirements and notification process for the applicant to obtain the permission from the Authority prior to the importation and/or placing of custom-made medical devices in the market. This document does not cover the medical devices that are patient-matched, adaptable or mass-produced and these medical devices shall be registered with the Authority.

PRESS RELEASE MEDICAL DEVICE AUTHORITY (MDA), MINISTRY OF HEALTH MALAYSIA MDA INTRODUCES Its NEW ONLINE PAYMENT SYSTEM BAYARNOW

Bayar Now is a customer portal and payment gateway application service which provides electronic billings and payments services for all customers under Medical Device Authority (MDA) to provides bank transfer payment solution. Bayar Now is directly integrated into the Government Resource Planning (GRP) Financial System and the transactions will be auto-generated and auto-posted on a real time basis.

To use BayarNow, customers will receive a link via their registered email once their application is approved by MDA. The BayarNow system enable customers to pay online via Financial Process Exchange (FPX) instead of using bank draft. Henceforward, customers are encouraged to pay using the new and customer-friendly BayarNow system.