Medical device companies today have to thrive in an evolving regulatory landscape where ensuring compliance is an ‘always-on’ effort. Often, complex barriers need to be navigated to ensure entry into a market. One such compliance is the one issued by the FDA – the U.S. regulatory agency responsible for protecting public health. The FDA lays down pre-determined product safety guidelines that companies are required to abide by before releasing a device in the market. The fact that a product has been approved by the FDA lends it credibility when sold in international markets, even outside of the United States.
The approval process, however, is lengthy and challenging. Applicants are required to produce relevant documentation, meet clinical data and study requirements, meet safety test requirements, and more. Any lapse in this process can lead to escalated production costs, delays in taking the product to market and running a high risk of being declared unsafe for use.
Risk management is becoming more and more critical to the medical devices business. Companies must incorporate quality control and risk management processes at every level. Nearly every major market where health related products and medical equipment may be sold is monitored. Implementation and maintenance of a quality management system is a mandatory prerequisite for product registration and for a medical device being made available for sale in such markets.
A robust Quality Management System (QMS) is a structured system of procedures and processes that relate to all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and more. Approvals from the US-FDA or obtaining CE Marking for your product in the European Union is easier with an effective QMS. Failure to conform to these requirements result in registration being denied and can jeopardize your standing with regulators post-market. Such a situation may disrupt sales completely and derail production plans for the future.
Johari’s extensive global collaborations allow us to understand complex national regulations and where they overlap. Our experts bring decades of experience with medical device QMS development, implementation, and audits for all device risk levels. Using this knowledge, we help develop customized regulatory strategies for your product.
Working closely with both, regulatory authorities and our partners, we seek and provide feedback on the appropriate classification for products by way of pre-submission meetings. Our associates worldwide are well-advised about compliance with post-market requirements and are informed about the most efficient regulatory route for approval and registration of product in global markets.
With over 40 years of experience, Johari Medtech provides regulatory services, assists in pre-market approvals and product registrations in every country. For business queries, visit our Services section.