White Papers

ENSURING MDR COMPLIANCE: LOOMING CHALLENGES IN THE EU FOR MEDICAL DEVICE MANUFACTURERS

The MDR was adopted by the European Parliament and the Council of the European Union in April 2017 and replaced the previous Medical Devices Directive (MDD). The transition period for the MDR was initially set to end in May 2020, but due to challenges faced by the industry and the COVID-19 pandemic, the European Commission postponed its application to May 26, 2021. To avoid a real and imminent risk of shortages of devices on the EU market and to provide additional time for manufacturers to adapt to the new regulatory requirements, the European Commission recently adopted Regulation (EU) 2023/607, extending the transitional provisions in Regulation (EU) 2017/745 (the “MDR”) to 2027 (specific circumstances) and removing the sell-off period in the MDR and Regulation (EU) 2017/746 (the “IVDR”) (Apr 3, 2023). By the last day of 2027, over half of a million medical devices currently approved for sale in the European Union will need to have achieved recertification of compliance the MDR. As part of the re-certification process and depending on their risk class  the device manufacturers will need to either demonstrate safety and performance of their products using real world data collected as part of their routine medical use and/or demonstrate safety and performance using data generated in clinical investigations. This white paper outlines how the looming challenge of re-certifying medical devices in the EU can be navigated. It also provides access to the resources the MedTech Alliance, consortium created for this purpose by experts providing complementary services GCP-Service, Gouya Insights, and of CSOFT Health Sciences, collectively offering a one-stop-shop to manufacturers of medical devices, particularly those of devices of higher risk categories required to collect additional real world data and/or conduct clinical testing of their devices. To learn more about MedTech Alliance and how it may help you getting your medical devices certified/ re-certified in the EU send an inquiry to medalliance@csoftintl.com.

Preparing for Regulatory Submission with Pharmaceutical Labeling Translations

Preparing for regulatory submission for a pharmaceutical product can often feel like an overwhelming task. The submission process for both clinical trials and market authorization requires not only meeting ever-changing regulatory requirements for documents and label formatting, but also increasingly is a crucial way to communicate to patients and providers, making considerations around patient centricity paramount. This white paper explores why working with a certified language service provider to integrate regulatory best practices with patient-centric language is essential to providing effective medical translations for pharmaceutical labeling.

Medical Communications and Medical Media in Patient Recruitment and Patient Engagement

Medical communications and medical media are driving forces behind some of the most significant advances in patient recruitment and patient engagement in the current clinical trial landscape. Since the COVID-19 pandemic, clinical trial models have shifted to become increasingly decentralized in structure, with an increased number of trials being conducted remotely and from trial participants’ homes as the much of the world remained restricted in travel.

Clinical Trial Translations:

New Requirements for Localization Under the European Union Clinical Trials Regulation (EU-CTR 536/2014)

The new EU-CTR has been crafted to harmonize the submission, assessment, and supervision of clinical trials with new objectives and guidelines. With these massive regulatory changes taking effect now in EU, this white paper highlights some of the specific changes that will dictate how clinical trials are conducted going forward and what applicants can expect from the updated approval process, particularly where support from language service providers (LSPs) will prove essential.

Tracking the Globalization of Clinical Trials:

Evolving Trends in Site Selection, Trial Reputation, and Localization

With an increased focus on developing cost-effective manufacturing processes, an emergence of innovative technologies, improvements in regulatory transparency, and a dramatic increase of resources allocated to innovation and research, the biopharmaceutical landscape has experienced a dramatic transformation.

Medical Device Market Overview and Regulatory Landscape in Latin America

Latin America (LATAM) promises to be one of the most profitable markets for clients in the medical device industry. As part of CSOFT’s series on the global life sciences market and regulatory landscape, this white paper will discuss the Latin American market’s medical device industry and regulatory landscape.

Machine Translation for the Life Science Industries: The Myth and the Truth

The rapid development of artificial intelligence (AI) and machine
learning has provided the translation industry with new capabilities,
such as machine translation (MT).

The EU MDR Labeling Journey:

Best Practices for Navigating the Latest Medical Device Labeling Requirements

The European Union’s regulatory landscape underwent a significant shift when the Medical Devices Regulation (EU) 2017/745 (EU MDR) officially went into effect on May 26, 20171.

A New Era of Patient-Centricity 

Patient-centricity has become one of the new catch phrases of the pharmaceutical industry. Indeed, although the industry appears to have patient-centricity in its DNA, the voices of the patients can easily get lost in all the hundreds of details in the drug development process.

China’s Ambitious Path Towards Universal Health Coverage (UHC)

In the last publication of CSOFT’s series on China’s healthcare reforms, the topic of how China’s radical regulatory makeover is shaking the entire pharmaceutical industry, both globally and domestically, was discussed.

Ensuring Quality in a Strategic Medical Writing Partnership

We are talking about two things here – quality, and medical writing – so first let’s examine both of these terms. Quality really means different things to different people – some consider it to be a degree of excellence, while others may see it as ‘being fit for purpose’. While perfection would be desired, it is always important to balance effort against output. Hence, rather than targeting perfection, it is important to focus on what matters: those critical data points that will make all the difference.

How the NMPA is Changing the Chinese Pharmaceutical Industry 

Since 2015, the NMPA (CFDA) has initiated a series of reform documents, with the purpose of pushing the Chinese pharmaceutical and medical device industry to a more mature and globalized environment.

How to Get Ready for eCTD Submission

China is currently recognized as the world second largest pharmaceutical market. However, the regulatory policies have been very challenging for many large foreign pharmaceutical enterprises, as well as innovative local companies.

‘Qwality’ Not Included

The ability to rate translation quality in an effective and uniform manner has long been a requirement of the industry, but is also crucial to high-risk projects such as translation for patient safety medical device labelling.

The Ins and Outs of Translation Memory Maintenance

Translation memory is a vital part of your business’s assets. As your business experiences change and grow, your TM will expand as well. In an ideal situation, it should continuously learn your company’s multilingual content and improve itself to provide you with efficiency, accuracy, and low costs that are necessary for successful globalization. Whereas in reality, it often collects and stores unwanted data.