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Regulatory Affairs Updates 40/20

Medical Devices - Guidelines and Regulations Worldwide



The TGA published a guidance regarding the regulation of personal protective equipment (PPE) and COVID-19 due to an increasing interest in understanding the regulation. The guidance contains an overview of how these products are regulated and information for manufacturers of PPE to help meet regulatory obligations.


The Mexican Ministry of Health (MoH) declared that all administrative activities and regulatory procedures will resume after being suspended due to the COVID-19 pandemic. Registrations and renewals of medical devices are processed now again by COFEPRIS, the Federal Committee for Protection from Sanitary Risks. In Addition they will extend the validity of registrations and deadlines.


The TGA issued two consultations as part of the reform program of the regulation of therapeutic goods in Australia:

  • Proposed enhancements to adverse event reporting for medical devices
  • Exploring options for the introduction of an Australian Unique Device Identification (UDI) System

Everybody is allowed review the consultation paper and provide a response using a online survey until the 18th of November. A good chance to actively take influence on the legislation.


The Chinese National Medical Products Administration NMPA issued a "Catalogue of Class III Medical Devices Subject to Clinical Trial Approval (2020 Revised Edition)" regulating the development of clinical trials of medical devices in China. The revised catalog:

  • adds the description of the common principles of applicable products,
  • adjusts the description of 6 catalog products,
  • deletes 2 products, and
  • updates the classification code.


The Russian Ministry of Health published an order to update the classification and registration of software as a medical device (SaMD). This order follows the approach of  the International Medical Device Regulatory Forum (IMDRF) and is suppose to make the regulation of SaMD more efficient and transparent. Additionally, the MoH issued two draft orders containing the following amendments:

  • Abbreviated approval process for new SaMD, including software using AI technology
  • The technical requirements concerning the technical files and IFU for SaMD


The FDA issued a new guidance for the Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". This guidance is addressed to the industry to assist in preparing the registration (e.g. PMA, IDE, 510(k), etc.) of medical devices that come into direct or indirect contact with the human body. In particular it is providing further clarification and updated information on the use of ISO 10993-1 in order to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body.

A catalog of regulatory science tools to help assess new medical devices was published by the FDA. The purpose of these tools is to use the most innovative science to speed medical device development and patient access to safe and effective medical devices. But these tools don’t replace FDA-recognized standards or qualified medical device development tools (MDDTs).

The FDA launched a Digital Health Center of Excellence (DHCoE) that’s aims to help digital health stakeholders to advance health care and digital health innovation. The objectives are:

  • Connect and build partnerships
  • Share knowledge, drive synergy, and advance best practices
  • Innovate regulatory approaches

The FDA will discuss the purpose and functions of the DHCoE in a webinar on two dates to choose from. This virtual listening session for digital health device manufacturers, developers, health care providers, researchers, and other stakeholders is free and registration is not necessary.


The Taiwan FDA published “Technical Guidelines for the Inspection and Registration of Medical Device Software for Artificial Intelligence/Machine Learning”. The guidelines provide help for the registration of medical device software that is using artificial intelligence/machine learning technology in Taiwan.

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