The importance of medical writing has been highlighted over the years in healthcare and, notably, for medical devices. Approval from the Regulatory agencies is highly dependent upon the scientific documents devised. Further, the continuous innovation in the medical device industry has simultaneously strengthened and changed the scope of medical writing. Given the increasing complexities in the current scenario, manufacturers face considerable challenges while placing the devices in the market. Some of the key challenges are listed below:

The adaptation of medical writing bloomed through the ever-evolving medical device industry coupled with the implementation of stringent regulations in the countries. Given the dynamic nature of the medical device industry, it is noticed that manufacturers who aim to place their medical device/s in the market are focusing diligently on medical writing for Regulatory approvals, as it involves drawing up a structured document complying with the Regulatory requirements. Several techniques and tools have been devised and are still being developed to implement effective documents.

The clinical evaluation is a procedure for demonstrating the safety and efficacy of the medical device. The documentation of the clinical evaluation process is called a Clinical Evaluation Report (CER). CER holds a significant position when placing or distributing medical devices in the European Union (EU). The report aims to establish the device’s intended benefits for users when weighed against the associated risks.

The most significant and crucial step in the device approval process is the labeling aspect. The safe and proper use of medical devices by patients and those who provide care for patients depends on accurate labeling with all the necessary information to ensure market access. Article 63 of the " Act on Securing Quality, Efficacy, and Safety of Products, Including Pharmaceuticals and Medical Devices" specifies medical device labeling regulations for manufacturers who intend to market their products in Japan.

The establishment of European Union Medical Devices Regulations (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/746 posed additional requirements. The significant aspect highlighted was implementing the Post-Market Surveillance system (PMS). Enabling PMS will ensure the devices' safety even after being launched in the market.

In-Vitro diagnostics (IVD) are products that are reagents, instruments, or systems that can detect diseases or other conditions and monitor a person’s overall health to help cure, treat, or prevent diseases.

The classification of an IVD determines the appropriate premarket process for approval. The FDA classifies IVD products into Class I, II, or III based on the associated risk.

The United States Food and Drug Administration (US FDA) released guidance in December 2022, a revision of the guidance titled ‘Failure to Response to an ANDA Complete Response Letter (CRL) Within the Regulatory Timeframe Guidance for Industry,’ of July 2022. It is meant to guide the applicants of Abbreviated New Drug Applications (ANDAs) submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). A complete and relevant response to a CRL is crucial for the approval of the generic drug.

The introduction of high-quality and reasonably-priced generic drugs in the market is a prevalent challenge for multiple Health Authorities. Several countries are taking steps to address this issue and make more generic drugs available in the market, consequently increasing the competition at a global level.

China’s pharmaceutical sector is witnessing changes and advancements frequently. In a recent shift, the National Medicinal Products Authority (NMPA) has made electronic certificates for drug registration in China possible. This has been done as an initiative to deepen the reform of the pharmaceutical market and drug supervision. The declaration was given by the NMPA under announcement no. 83-2022, and China has started issuing these e-certificates from November 01, 2022.

Medical device labeling is a critical part of any device. It provides information to the consumer in textual or graphic forms on the packaging. It intends to increase the safety and usage instructions for consumers. When there is a false or misleading label, it is regarded as a misbranded medical device or adulterated medical device. It is considered a legal offense when a device fails to report essential product information based on its judicial requirements.