Regulatory Affairs Updates | CW09 21| qtec-group

Regulatory Affairs Updates 09/21

Medical Devices - Guidelines and Regulations Worldwide


MDCG guidance on EUDAMED

The newest guidance was just released last week: the MDCG published a “Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional”. The 31 pages long document addresses the difficulties caused by the still non-functional EUDAMED database. The requirements of Regulation (EU) 2017/745 are listed in detail with corresponding instructions for compliance. The document offers a lot of important information which will be helpful for a lot of medical device manufacturers.

Guidance on legacy devices

A new guidance paper was published dealing with the management of legacy devices. These devices were CE marked under the Directives 93/42/EEC or 90/385/EEC. Registration requirements of MDR and IVDR respectively still apply but a few exceptions exist. The guidance describes the identification process of legacy devices in EUDAMED (as soon as it is functionable) and format of the EUDAMED DI which is required for each device. Find the guidance by clicking the link:


The International Medical Device Regulators Forum published the final document on principles of the classification of in vitro diagnostics. The document provides four risk classes A, B, C and D for IVDs and classification rules based on the intended use, the impact of the result and others.


The Asian Harmonization Working Party has once again published a series of presentation with updates and general information from its member states. This time the focus is clearly on COVID-19. The following countries are included: India has updated their regulation on COVID-19 Reagents/Kit giving a detailed regulatory pathway for domestic manufacturing and import. It also provides acceptance criteria concerning sensitivity and specificity for this kind of IVDs.

In Indonesia, a couple of measures were taken to accelerate the import of products needed in handling COVID-19. The “relaxations” include priority service time and simplification of requirements.

The Saudi Food & Drug Authority has also installed a couple of simplifications to manage the outbreak of COVID-19. The approval process in Saudi Arabia is expedited and the extent of the technical documentation required for approval is reduced. In total 16 measures were introduced including the possibility of Emergency Use authorization (EUA).

Other presentations cover the regulatory framework of Korea, Singapore and Thailand. They can be found on the website of AHWP:


The Southeast Asian country is experiencing troubling times since the military took over the power from the democratic party and declared a state of emergency. The next election was announced for early 2022. Currently the website of the Myanmar Food and Drug Administration is not available.


Australia published a couple documents in February. The first one deals with the regulatory changes for software based medical devices that took effect last week. It is accompanied by an additional document about clinical decision software. Both documents should be checked in order to identify possible regulatory gaps.

The third document outlines the TGA’s approach to identify and manage risk associated with therapeutic goods. It deals with medical devices as well as biologicals and medicines.

The fourth one is a collection of answers to frequently asked questions on personalized medical devices.


New regulation for the import of samples

Medical device samples are subject to new import procedures before entering the country for registration or renewal reasons. According to the regulation No. 661n those samples need an import permit, and the required documents have to be submitted electronically.

New PMS requirements in Russia and Kazakhstan

Russian Order No. 980n and a new Kazak regulation describe requirements for post-market surveillance which apply to medical devices that are registered locally in the respective country. For devices that are approved under the Eurasian laws the Eurasian regulations No. 174 applies.


Singapore’s Health Sciences Authority has launched a remarkable medical device grouping tool. It will help to determine the medical devices grouping category prior to submitting the registration application. By answering the questions to your devices you will find out the correct grouping term.

COVID-19 related

The MDCG remains busy and published another guidance document. It provides answers to frequently asked questions on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19. While some questions are rather basic, the answers to questions on sensitivity and specificity of COVID-19 tests as well as on further guidance can be helpful. In conclusion, the paper can be helpful for companies aiming to place their IVD products on the European market for the first time.

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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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