As a medical device manufacturer, you must understand and prepare for the United States Food and Drug Administration’s (US FDA’s) inspections to maintain compliance and ensure that your medical device can be marketed and distributed without legal impediments. The US FDA’s Regulatory oversight includes ensuring that devices are safe, effective, and meet the necessary quality standards. Here is what you need to know about the US FDA’s inspections and enforcement actions and how to prepare for them.
In the pharmaceutical industry, data security is paramount to maintaining compliance with regulatory standards and safeguarding sensitive information. With the increasing threat of cyber-attacks, pharmaceutical companies must prioritize cybersecurity measures to protect their data and uphold the highest compliance and patient safety standards.
In the heavily regulated pharmaceutical industry, internal Current Good Manufacturing Practices (cGMP) audit processes and efficient audit systems serve as vital control mechanisms, ensuring compliance with myriads of standards and regulations. They provide an unbiased and comprehensive evaluation of a company’s processes, systems, and operations, identifying any deviations from or discrepancies with the applicable Regulatory/cGMP requirements, which may impact product quality, safety, or compliance.
From October 2023 onwards, the mandatory registration of Class C and D medical devices in India will require conformance with the Quality Management System (QMS) requirements, as per the Indian Medical Device Rules (IMDR) 2017. Thus, medical device manufacturers will have to implement a QMS that meets the requirements of Schedule V of the IMDR 2017. It is mandatory for manufacturers to be compliant with these requirements for the successful registration of their Class C and D devices.
Maintaining a Quality Management System (QMS) is the foundation to demonstrate Regulatory compliance in the medical devices industry. QMS is a structured system of procedures and processes, covering all the aspects of design, manufacturing, risk management, supplier management, complaint handling, clinical data, storage, distribution and product labeling of medical devices. To meet the comprehensive QMS requirements, there is a need to adapt to the ISO 13485 international standards.