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An Overview of the Classification of Medical Devices

Health & Medical, Home Health Care

46 The Peninsula | Paradise Point, Queensland, 4216

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More information about An Overview of the Classification of Medical Devices

The top medical device companies play a vital role in the medical realm. Without them, no new technologies and equipment are innovated for the use of medical professionals. There will be no tools and instruments that can diagnose, prevent, or treat various medical conditions.

Now, although we have already provided you with the gist of this article, allow us to go deeper and be a bit technical. This way, we can better explain what it is that medical device companies exactly do. Here you go:

Abide Market Regulations and Seek Approval

First off, all top medical device companies, regardless of where they are based or located, should abide and follow the regulations of the market they are looking to enter.

For instance, for a medical device to be readily available in the United States, it has to follow the country’s medical device regulations. It has to comply and submit papers for the device to be approved and regulated by the United States Food and Drug Administration or FDA.

Once all the required documents are submitted, regulating bodies will then classify the device.

Medical Device Classification

Medical devices are generally classified into three major categories:

Class I Medical Devices - These devices pose low risks and they don’t really have lots of complicated regulatory controls. Manufacturers of these devices don’t need to prove the effectiveness and safety of these products. They are not even required to submit a Premarket Notification 510(k). Examples of devices that are classified under class I are elastic bandages and enema kits.

Class II Medical Devices - These medical devices are considered more harmful than class I devices, so manufacturers are required to submit a Premarket Notification 510(k). The most common devices that are considered class II are handheld surgical instruments, infusion pumps, pregnancy test kits, and powered wheelchairs.

Class III Medical Devices - These devices are the riskiest because they can be potential causes of injury or illnesses. Because of the risks involved, these devices go through a more rigorous approval process. Companies that manufacture these devices are asked to submit clinical data to the FDA for evaluation purposes. From that, a decision will be made whether or not the product can be marketed. Class III medical devices include diagnostic tests and implantable pacemakers.

When it comes to seeking approval, the Premarket Notification 510(k) can take up to 90 days to process. After this, it will be filed for approval. Once approval has been granted, companies can already start selling their medical device products on the market.

Wrapping Up

While the approval process seems very straightforward, know that even the top medical device companies still seek help from professional medical compliance consultant like Vicki Partridge. So, if you feel that the entire approval process is too overwhelming, do not hesitate to reach out to us.

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Last update: 2020-10-16 17:20:43