QS Pakistan has full expertise for Device Listing, Establishment Registration with US FDA as well as in Good Manufacturing Practice (GMP).

More detail is as under:

What Is Medical Device Listing

Most medical device establishments are required to register with FDA must also identify to FDA the devices they have in commercial distribution including devices produced exclusively for export. This process is known as medical device listing and is a means of keeping FDA advised of the generic category(s) of devices an establishment is manufacturing or marketing. 

Each generic category is represented by a separate classification regulation found in Title 21 Code of Federal Regulations Parts 862-892 or FDA assigned device name. Each regulation number or device name is associated with one or more product codes. Regulation numbers with more than one product code identifies the product in further detail. For example, "Manual Surgical Instruments for General Use," 21 CFR 878.4800, contains several product codes including GAB (disposable suturing needle), GDX (scalpel), HTD (forceps) and HRQ (hemostat).

Listing of a medical device is not approval of the establishment or a device by FDA. Unless exempt, premarketing clearance is required before a device can be marketed (placed into commercial distribution) in the U.S.

All device types classified as exempt from the Premarket Notification 510(k) requirements are subject to the limitations of exemptions. Limitations of device exemptions are found in the device classification chapters in 21 CFR xxx.9, where xxx is replaced with Parts 862-892 (e.g., 862.9, 864.9, etc.). Please be aware that it is your responsibility to ensure that you meet the exemption criteria and that your device does not exceed the limitations of exemption. If your device exceeds the limitations of exemption, you must submit a 510(k) and receive a letter from FDA stating that your device may be commercially distributed in the U.S. prior to marketing your device.

While there is no separate fee for listing your device, device listing is completed as part of the annual registration process.  Many device establishment types are subject to an annual registration fee.

 Who Must List

An owner/operator of an establishment not exempt under 21-CFR 807.65 who is engaged in the manufacture, preparation, propagation, compounding, assembly or processing of a medical device intended for commercial distribution (marketing) is required to list its device with FDA within 30 days of entering the device into commercial distribution in the U.S. This includes manufacturers, repackagers and relabelers, specification developers, reprocessors of single-use devices, remanufacturers, U.S. manufacturers of export only devices, and manufacturers of accessories and components that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose (that is, manufacturers of components or accessories that are intended to be sold or leased directly to the end user.). Foreign manufacturers and foreign exporters must list their devices prior to importing into the U.S.

Contract manufacturers and contract sterilizers are required to register their establishment and list their devices if they commercially distribute the device. Initial importers located in the U.S. are required to register their establishment; they are not, at this time, required to list their devices.

An establishment is required to list their device(s) if they are performing one or more of the following activities:

CONTRACT MANUFACTURER
Manufactures a finished device to another establishment's specifications and places the device into commercial distribution.

CONTRACT STERILIZER
Provides a sterilization service for another establishment's devices and places the device into commercial distribution.

FOREIGN EXPORTER
Exports or offers for export to the United States, a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the U.S. A foreign exporter must have an establishment address outside the U.S.

MANUFACTURER
Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

REMANUFACTURER
Processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or in any way changes the intended use.

REPACKAGER AND/OR RELABELER

Repackager:
Packages finished devices from bulk or repackages devices made for the establishment by a manufacturer into different containers (excluding shipping containers).

Relabeler:
Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.

SPECIFICATION DEVELOPER
Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment's name by a contract manufacturer.

REPROCESSOR OF SINGLE-USE DEVICES
Performs remanufacturing operations on a single-use device.

U.S. MANUFACTURER OF EXPORT ONLY DEVICES
Manufactures medical devices that are not sold in the U.S. and are offered solely for export to foreign countries.

Please note:

• Initial distributors ( importers) located in the U.S. are not required to list their devices.  However, they are required to register their establishment.
• Refurbishers and domestic distributors are not required to list their devices or register their establishment.