The term medical devices cover a wide range of medical equipment from common tongue depressors to highly sophisticated surgical and advanced diagnostic equipment that are used in various specialized medical disciplines. These different types of equipment are extensively used in various sized hospitals ranging from rural health clinics to multi-specialty hospitals providing tertiary patient care. Similar to medicines and medical technologies, the medical devices are also highly essential for maintaining proper patient care.
In this era of liberalization, medical devices are commonly imported in developing countries, which potentially increase the chances of unscrupulous commercial elements causing significant concerns for the safety of patients on whom the inferior quality devices are used. To avoid this, all the main countries have established or follow global standard regulatory control guidelines for medical devices to prevent the use of substandard equipment, thereby minimizing the chances of putting patient’s life at risk due to the usage of inferior quality medicines.
Knowledge of Regulatory Guidelines
- The regulatory medical writers must possess sufficient knowledge of the regulatory guidelines to be followed for medical devices while developing regulatory contents for such devices. No single guideline will satisfy the requirements of every country, and many major economies follow country or region-specific regulatory policies for the medical devices. For instance, some countries have established regulations and restrictions on the production facilities of the devices and require Good Manufacturing Practice (GMP) certification for its usage on the patients. Some countries would have complex quality controls and the respective regulatory authorities have put in place different policies and guidelines for the deployment of medical device principally to safeguard their patients from hazardous, unsafe and inferior technologies.
- must have a good understanding of the standardized regulatory guidelines commonly used by major economically developed countries. Major global healthcare agencies like WHO and European commission have established regulatory guidelines for medical devices that are considered to be good standards and followed in many countries
Important challenges of regulator writers of Medical Devices
- Limited publications are available for medical device writing as compared to writing in pharmaceutical activities and fewer patients per
- Medical device writing necessitates writers to undergo frequent product updates particularly laboratory software and diagnostic devices
- Regulatory requirements vary significantly depending on the class of device and hence device writers should have sufficient understanding of regulatory requirements of different devices
- Medical equipment manufacturing companies give more emphasis for commercial activities and relatively less emphasis on publishing particularly diagnostic equipcal devices.
Thus, a good knowledge of various challenges faced by the sector will enable the regulatory medical writers to develop competence and become an expert writer in the field of regulatory medical writing relating to medical devices.