January 6, 2022 Regulatory Updates
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Medical Devices – Asia Regulatory Updates Roundup Dec 2021

India (CDSCO)

Draft GSR 850(E)_Amendment of rule 36(3) MDR to include United Kingdom

DRAFT RULES

1. (i) These rules may be called the Medical Devices (……Amendment) Rules, 2021.
 (ii) These rules shall, unless specified otherwise, come into force on the date of their final publication in the Official Gazette.

2. In the Medical Devices Rules, 2017, in rule 36, in sub-rule (3), for the words “or the United States of America” the following words shall be substituted, namely:—
“United Kingdom or the United States of America”.

DraftS.O. 877(E)_Amendment of rule 46 of MDR for Unique Device Identification

DRAFT RULES

1. (i) These rules may be called the Medical Devices (……Amendment) Rules, 2021.
 (ii) These rules shall, unless specified otherwise, come into force on the date of their final publication in the Official Gazette.

2. In the Medical Devices Rules, 2017, for rule 46, the following rule shall be substituted, namely:—
“46. Unique device identification of the medical device.— With effect from the date as may be specified by Central Government, a medical device, approved for manufacture for sale or distribution or import, shall bear unique device identification in the manner as may be determined.”

List of the certified Medical Device Testing Laboratory (MDTL) under MDR, 2017- regarding

This office had registered a Medical Device Testing Laboratory (MDTL) to carry out test or evaluation of a medical device on behalf of the manufacturer (Form MD-40 of MDR, 2017). There are 18 MDTLs have been registered with CDSCO till dated 07.12.2021 under the provisions of the Medical Device Rules, 2017 (Form MD-40 enclosed). The updated list of medical devices testing laboratories registered with CDSCO under the provisions of Medical Devices Rules, 2017 to carry out test or evaluation of a medical device on behalf of manufacturer is given in below web link:

SINGAPORE (HSA, SINGCERT)

Medical Device cyber security vulnerability: Apache-Log4j

Fifth Update on 29 Dec 2021:
Apache has released Log4j version 2.3.2 (for Java 6), 2.12.4 (for Java 7) and 2.17.1 (for Java 8) to address an arbitrary code execution vulnerability.
CVE-2021-44832 – A vulnerability that exists due to a lack of additional controls on JNDI access within Log4j. Attackers with write access to the Log4j logging configuration could configure the JDBCAppender to reference a JNDI URI data source and load arbitrary Java code. This could lead to arbitrary code execution and affects versions 2.0-beta7 through 2.17.0 (excluding security fix releases 2.3.2 and 2.12.4).
Users of Apache Log4j are advised to upgrade to the latest version accordingly.
Fourth Update on 22 Dec 2021, Third Update on 20 Dec 2021, Second Update on 17 Dec 2021
First Update on 16 Dec 2021, Original Advisory published on 14 Dec 2021

VIETNAM (FDA)

The label of a goods with unidentified origin must show the place of completing the final stage to finish goods

Accordingly, manufacturers, importers or exporters shall themselves identify and show the origin of their goods and ensure truthfulness, accuracy and compliance with the law on origin of exports, imports and domestically manufactured goods or treaties to which Vietnam has acceded. In case the origin of goods cannot be identified under the above regulations, the label must show the place where the final stage to finish goods is completed.

The place of completing the final stage to finish goods shall be presented with one of the following phrases or combined phrases showing the stage of finishing goods “assembled in”, “bottled in”, “mixed in”, “finished in”, “packed in” or “labeled in” followed by the name of the country or territory where the final stage to finish goods is completed.

Additionally, labels of goods being health equipment manufactured in the country or imported for circulation in Vietnam must show the name and address of the health equipment owner or the name and address of the owner of the health equipment circulation registration number. In case the health equipment does not have a circulation registration number, the import permit must show the name and address of the health equipment owner and the name and address of the organization or person. This Decree takes effect on February 15, 2022

JAPAN (PMDA)

The 40th Science Board Meeting

List of Handouts
Confidentiality Classification of Handouts
Document 1 Outline of the Report from Microbiome Subcommittee
Document 2 Report from Micro biome Subcommittee
Document 3Activity Report on the Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs)Including Exosomes
Document 4 Report on the Conference Presentation by the Subcommittee on Computer Simulation
Document 5Outline of Study Theme on AI-based Software as a Medical Device
Document 6Current Development Stage of AI-based Software as a Medical Device
Reference
Document 1 The 5th Term Science Board Member List Reference
Document 2 (1) Letter to the Editor Published in “British Journal of Clinical Pharmacology”
https://doi.org/10.1111/bcp.15065Open a new window
(2) Brief Research Report Published in “Frontiers in Medicine”
https://doi.org/10.3389/fmed.2021.756870Open a new window

AUSTRALIA (TGA)

Essential Principles – consent for noncompliance

There are Criminal Offences under S41MA and Civil Penalties under S41MAA of the Therapeutic Goods Act 1989, for persons who import, supply or export medical devices that do not meet the Essential Principles for safety and performance.
However, there may be extenuating circumstances preventing compliance to one or more parts of an Essential Principle for a limited period of time.
In such circumstances sponsors may request consent to import, supply or export medical devices which do not meet an Essential Principle.

Medical device patient information leaflets and implant cards

This guidance provides an overview of:
This document is designed to assist manufacturers in completing the relevant Declaration of Conformity and to assist sponsors confirming that documentation prepared by the manufacturer is complete.

Guidance for manufacturer’s declaration of conformity for system or procedure packs

Other than Class I or Class 1 IVD system or procedure packs

  • the different types of patient information materials (patient information leaflets and patient implant cards);
  • when patient information must be supplied;
  • how to meet the mandatory requirements for patient information; and
  • best practice requirements for patient information.

Oxymed Australia Pty Ltd and director Malcolm Hooper ordered to pay $3 million for unlawful advertising of hyperbaric oxygen therapy devices

The Federal Court of Australia has ordered Oxymed Australia Pty Ltd to pay $2 million for advertising medical devices intended to administer hyperbaric oxygen therapy in breach of the Therapeutic Goods Act 1989 (the Act).

Software-based medical devices FAQs

Frequently asked questions regarding the regulatory approach of the TGA for software-based medical devices
https://www.tga.gov.au/software-based-medical-devices-faqs

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