Author: Criterion Edge Writers
Staying current with national and international regulatory updates is a constant challenge for those in the medical device industry. Medtech Insight, already known for their website that provides up-to-date information with current trends and market data, has launched a new tool, the Global Medtech Guidance Tracker. This useful addition “comprehensively tracks regulatory guidance documents issued by medtech authorities from around the globe,” providing one location to read and search worldwide regulatory updates.
The tracker is continuously updated, with new documents added every month. It organizes salient data by country, organization, and status (draft or final). Links in the tracker provide access to data, documents, and changes happening in real time. The tracker allows you to search data and original documents from 22 national and international regulatory organizations, including the Health Products Regulatory Authority (HPRA), European Commission (EC), and China FDA (CFDA).
Here are some recent additions to the tracker:
- A March 2022 update from the European Commission (EC) on the Joint Implementation and Preparedness Plan for Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR), which outlines regulatory priorities for the upcoming 26 May 2022 implementation of updated IVDR legislation.
- The 2 March 2022 notice released by Health Canada (HC) on regulations relevant to clinical trials for medical devices and drugs relating to COVID-19. In this notice, the Canadian government outlines its plans to replace an interim order with new regulations, which will continue to offer flexibility and expeditious review for COVID-19 related clinical trials.
- A 16 March 2022 draft of India’s Department of Pharmaceuticals’ (DoP) Uniform Code for Medical Device Marketing Practices for which they are requesting feedback and comments from the medical device industry and its stakeholders.
- The Medical Device Authority (MDA) of Malaysia’s 25 March 2022 draft document, Personal Protective Equipment (PPE)- Requirements, which provides clarification on PPE that is regulated under the Medical Device Act of 2012.
Changes in the medical device industry are happening globally, in real time, and it can be difficult to remain informed when new or updated regulatory information is released. Medtech Insight’s Guidance Tracker is a convenient, concise tool that compiles guidance and data from around the world in one spot, making it easy to check for ongoing updates and critical new information.
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If your organization needs support getting your technical documents ready for the transition to MDR or IVDR during this ever-changing landscape of medical regulations, Criterion Edge has the expertise and bandwidth to work with you and get the job done. We have expert medical writers to support your organizations in developing the necessary documents to ensure a smooth transition and meet these fast-moving deadlines. Get a free consultation today.