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Medical Device Manufacturing: The Role of Regulatory Affairs

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The medical device industry plays a pivotal role in enhancing the quality of services within the healthcare industry. Almost all companies aim to put to an end common medical problems through their innovations. To safeguard the interest of the customers receiving the services and the companies themselves, regulatory bodies help to ensure that the devices are market ready and safe for use.


These regulators survey the quality of the products throughout the lifecycle to help prevent any inconveniences. This makes the role that a regulatory affairs office, one that cannot be ignored. With a committed department, your organization can not only embrace keeping up with new rules but also make use of the perks that the rules might have for your company.


Here are four roles that the regulatory department will play:

Premarket Regulation

It would be counterproductive to develop a medical device that has the potential to put your business on the undesirable side of the law. The regulatory affairs department can help in the development of your product by advising the developers on what to do to make the product viable for the market. Additionally, they also advise on how specific additions to your product will affect the regulations you have to comply with.


Since regulations vary from region to region, according to EMMAInternational.com, you will have to adjust your product to meet the international regulatory requirements. A great regulatory affairs department will determine the adjustments to make to evade any legal bottlenecks during sales.

Marketing Application

Once the product design is completed, the design team will rely on the regulatory affairs team to formulate a premarket submission for the various regulatory bodies to accept the device to be marketed. The officials should at first identify whether there are other products which are similar to their own, often referred to as the predicate, in order to determine the type of submission to draft.


In case there is a predicate available, the department has to showcase that their product is as effective and safe as the predicate through the submissions. If the product is the first of its kind in the market, then the department will have to submit a PMA (premarket approval application) to prove the product is safe for use, according to Drug Watch.

Post-Market Surveillance

Just because your medical device received the go forward to be marketed doesn't mean that it is completely safe for use. Often, unintended issues might occur when it is already on the market. It is the role of your regulatory affairs department to survey any issue with the product.

After detecting an issue, it can work hand in hand with the regulatory bodies to find a solution to eliminate such adverse effects from taking root. Additionally, the department can detect an issue before it becomes a major problem. This will help safeguard the integrity of your organization.

Identifying Changes in the Global Regulatory Landscape

New flaws are identified daily in the different healthcare products worldwide. To counter these flaws, the regulatory bodies tend to come up with new regulations. While complying with your country's regulations is typically easy since you can work on the changes after every update, it might be tough to do so for the international markets.



The regulatory department will survey for any changes in the international markets that you operate. This will ensure that you can be on the right side of the law. For the officials in the departments to perform this role optimally, they have to be well versed with both internal and international regulatory requirements.


Complying with regulations is a sure way to fortify your business. It will not only help you evade non-compliance fines but also increase your chances of landing serious business partners and investors. Consider having a regulatory affairs department to increase your business' compliance rates.