2018 is going to be a big year for medical device regulation in the United States. For the past few years, the U.S. Federal Drug Administration (FDA) has been rolling out a systemic standardized system to uniquely identify all medical devices produced or distributed in the United States. This has been a part of the much larger effort by the FDA to protect medical providers and patients while simultaneously regulating the medical device supply chain and further standardize the development process for medical devices and consumables. While new regulatory developments are commonplace in their vocation, the current sequence of events will likely create a higher demand for Quality and Regulatory Assurance professionals in the immediate future.
Most global markets will have a form of a Unique Device Identification (UDI) system in place within the next 5 years. Based on the current statuses the European Union, China, and elsewhere many markets will operate with a single UDI code set that will further streamline their national regulation and compliance processes.
In the United States, the FDA has established a single UDI system that will affect all medical device manufacturers and classes and has been slowly introducing this system over the past few years to allow time for labeling, packaging, and documentation changes to occur.
2018 will be a critical year for the FDA’s rollout as the compliance date for all medical device labeling, packaging, and direct markings arrives in the Fall of 2018. The previous checkpoint was back in September of 2016, and since then only Class III (things like pacemakers, automated defibrillators etc.), Life-supporting, and Class II labels and packaging have been subject to UDI compliance.
2018 Compliance Highlights
By September 24th, 2018:
– All Class II devices (things like surgical needles, x-ray machines, nebulizers, etc.) must bear a Unique Device Identification (UDI) code on the device itself if the device is intended to be used more than once.
– Labels and packages of Class I medical devices (things like bandages, gloves, wheelchairs, etc.), and all devices yet to be classified, must bear a UDI.
– Data for all Class I devices are required to be submitted to the GUDID database.
Global UDI Database
The Global Unique Device Identification Database (GUDID) is the database administered by the FDA that will serve as the primary reference catalog for every device with a UDI. In collaboration with the National Library of Medicine, the FDA has created a publically accessible portal to make device identification information in the GUDID available for everyone including patients, caregivers, healthcare providers, hospitals, and industry. This enhanced transparency will help with future regulatory and compliance functions while also serving as a better reporting method for medical practitioners. In general, the combination of the UDI and GUDID systems should rapidly improve medical device regulation and compliance in the U.S.
How Will This impact the Job Market?
Generally speaking changes in regulatory processes can create a great deal of mobility for QA/RA professionals. These shifts or new phases in compliance create a demand for “in the know” professionals that can help all forms of entities to navigate the evolving landscape. With Class II and Class I medical devices creating the bulk of medical device products, the impact of this newest phase of regulation is extremely vast.
In the United States, we can expect to see not only the demand for QA/RA professionals to increase but also for skilled manufactures for medical device and supply companies as well. According to CareerBuilder demand reports, in February there was a 10% increase for QA/RA specialists. As new packaging and labeling requirements take shape, companies who have not already enacted their final compliance processes will be shifting to new operations that could likely affect their immediate staffing and hiring needs.
As an added layer, lawmakers recently delayed reestablishing the Medical Device Excise Tax (MDET) for another 2 years. This relinquishes medical device manufactures of a 2.3% tax obligation on their U.S. revenues until 2020. These additional revenues will certainly act as a stimulus for expanding operations and workforce, which is conveniently timed with the new FDA regulatory laws.
Developments in China
The U.S. FDA mandates that foreign manufacturers must meet the applicable medical device regulations in order to import devices into the U.S. These requirements include registration of establishment, a listing of devices, manufacturing in accordance with the quality system regulation, and medical device reporting of adverse events among others.
Recently, the China Food and Drug Administration (CFDA) announced that their own regulators are in the process of developing a new set of medical device standards over the next two years (2018-2020) to better align their processes with the developing international standards. The implications of these developments in conjunction with the U.S. FDA rollout again bode well for QA/RA professionals. Undoubtedly, Chinese manufacturers that are looking to export their products to the U.S. and vice-versa will be in need of increased staffing in their regulatory and compliance sectors.
Assemble The Best QA/RA Professionals For Your Company
In today’s fast-changing and complex international regulatory environment, it can be difficult for companies of any size to ensure appropriate compliance. They require the best professionals and trust that these individuals will help them to navigate the required red tape without costly delays and setbacks.
Therefore, when it comes to locating and hiring the best QA/RA professionals, Comrise can assure your company attracts and acquires exactly what you need. With international offices throughout Asia, Comrise can also help your company source professionals that are personally attuned to your target markets’ regulations and federal processes.
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While many medical device companies are outsourcing some or all of their regulatory affairs tasks to ensure compliance in international markets, Comrise can help you acquire in-house staff so your company culture and productivity can continue to shine across all divisions.
With so many international entities reshaping their medical device regulatory and compliance mechanisms, don’t let your company get left behind and risk negative and costly consequences. Assemble your QA/RA team now and let Comrise staff your success.