Regulatory Affairs Updates | CW06| qtec-group

Regulatory Affairs Updates 06/21

Medical Devices - Guidelines and Regulations Worldwide



The Corona pandemic keeps the world on hold even one year after its first appearance. The MHRA published two guidance papers on software or apps being used during the COVID-19 pandemic. The first one is addressed to manufacturers thereof and deals with regulatory flexibilities and the possibility of exceptional use authorization for these kind of medical devices. The second paper is addressed to members of the public and professional users. It underlines the importance of valid conformity marking.


The listing of Class I non-sterile, non-measuring medical devices and Class I IVD medical devices in Australia has changed. Instead of just holding the Declaration of Conformity for possible assessment, it now has to be provided with the application. In addition to minor changes, non-mandatory audits are increasingly important for TGA to verify compliance. These changes do not apply to Class I Export Only and Class I IVD Export Only medical devices.


Japan is currently being hit particularly hard by the Corona pandemic: the numbers are only decreasing slowly, and hospitals lack capacity. Anyhow, the Pharmaceuticals and Medical Devices Agency has recently revised their JMDN List. The list includes generic medical device descriptions and product codes. Make sure your device is listed before you begin the registration process!


3D printing is a highly promising technique enabling the development of medical devices with completely new characteristics. Singapore’s Medical Device Branch has published a draft document “regulatory Guidelines for 3D Printed Medical Devices”. It provides information on the regulatory requirements for 3D printed medical devices. The MDB is seeking for your feedback until February 28th!


The Asian Harmonization Working Party has published a couple of presentations on regulatory updates of some member countries. Even if some presentations do not only include updates, they provide an good overview on possible registration pathways. Too many papers to scroll through? We got a summary for you:

  • Bahrain – manufacturers are now required to have a valid ISO 13485 certificate for registration.
  • Saudi Arabia – the Saudi Food & Drug Authority has adopted the latest version of the ISO 13485, which is now a requirement for registration in Saudi Arabia. Other updates affect advanced technologies and applications, unique device identifications, classification and efforts taken during Covid-19.
  • Vietnam – the country continues to make progress in regulating medical devices. The presentation summarizes recent achievements and requirements to come.

Also China and Oman have submitted presentations. You can find all files here:

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All updates compiled in one PDF file:

You can download all Regulatory Affairs Updates compiled for you as a PDF under the following link.

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