Medical Device Registrations?Promoting & Protecting Health

Medical Device Registrations?Promoting & Protecting Health

One of the most essential tasks to know for marketing medical devices is to know from where to start. What are the different steps of marketing and in what order they need to be taken. Devices are needed to be subjected to various general controls and Act contained in the procedural regulations.

Comprehensive regulatory assistance which professional medical device consultants have been helping the manufacturers in bringing registrations for their devices. They follow different essential methods to check the safety and potency of products to make registration process simple and easier. Adding to it, they come with quality testing experts, researchers and scientists to make the process effective and simple.

This is the fact that medical device registrations promote and protect health.

The question arises here how it does so? This article will help to get answers in this regard. Check out the points discussed below.

Meet the definition

The very first step that FDA takes for the registration is to check whether the products clear the definition of medical device or not. The product may be a drug, a biological product regulated by component in the FDA. Or your product may be any medical device or electronic radiation emitting product with different requirements.

Classification of products

Medical device registrations are done on the basis of classification of devices. Three different classes are there into which products are classified by FDA.

Actually the classification helps in identifying the regulatory control specified for different class of products. All such classifications are meant to assure the effectiveness and safety of devices. And classification most importantly meant to identify the marketing process, pre-market approval, etc. And manufacturers are required to obtain the FDA clearance or approval for marketing.

Selection of marketing application

Step three which is taken by FDA for medical device registrations is the development of data or information which is necessary to submit marketing application and also to obtain FDA Clearance to the market. For some applications and submissions, clinical performance data is required to obtain the market clearance. In addition to market clearance, conduct of the trial is also done in accordance with FDA’s Investigational Device Exemption.

Premarket requirements of products include labeling, registration and listing. These all are done in accordance with FDA’s regulation process.And all these steps are followed to make sure the medical device registrations are being given to the medical devices that are effective and safe to use for different medical applications.

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