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Medical Devices Registration

With ST&T Research Intl acting as your FDA official correspondent, we will be responsible for the annual registration of the establishment and the device listing. ST&T will be also available to assist you with the labeling and Medical Devices Master Files.

1. Medical device Establishment Registration and Listing

       Registration: Owners or operators of business that are involved in the production and distribution of medical devices intended for use in the US are required to register annually with the FDA. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices.

       Prepare and file annual renewal of registration of establishment: All devices establishments must complete their annual registration even if no changes have occurred. Listing information must also be reviewed every year.

       Annual fee payment: Manufacturers, packers, labelers and those involved in the reprocessing of medical devices must pay an annual fee when renewing their establishment and listing.

      Update Registration and Listing information: Update changes to the registration and listing information at any time throughout the year

2. Premarket Notification Registration: 510(k)

     A 510(k) is a premarket submission, required to certain medical devices, to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to Premarket Approval. Scientific and technical information must be submitted for its review, ST&T Research Intl can assist you in preparing and/or reviewing the technical information to be submitted.

3. Label review

    ST&T can assist you in designing, reviewing or redesigning your medical device labeling to assure compliance with the FD&C Act.

4. Medical devices master files (MAF)

    To help preserve the trade secrets of the ancillary medical device industry and at the same time facilitate the sound scientific evaluation of medical devices, FDA established the device master file system. ST&T Research Intl can help prepare and submit the master files for review to the appropriate FDA office

5. Certificate of Registration

6. US Regulatory Agency

The US FDA & CUSTOMS (and most other importing countries) require that any domestic or foreign manufacturer and/or distributor who ships into/out of the country must have a local agent who can respond to FDA NDC filing/reporting, and Customs, legal and regulatory matters or questions which may arise concerning their products. ST&T has specialists who provide clients with these Regulatory Agent Services.

Acting as your U.S. Agent, your Company will be provided legal & science support for its efforts to market products in the USA.

 

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