In this article, we are going to discuss the requirements every medical device importer and exporter is required to meet if they wish to market their products in and out of United States.
Medical devices are one of the world’s most traded commodities. The United States stands top in both the export and import of medical devices as per recent statistics.
Considering the very nature of medical devices, testing their safety and efficacy becomes crucial as they directly impact the health and lives of mankind.
Manufacturers must adhere to numerous regulations of different countries for imports/exports to take place, the procedures for which often differ from country to country. Let’s take a closer look at the import and export requirements levied by the United States of America.
Import Requirements Every Medical Device Importer Needs To Know About
The U.S. Food and Drug Administration states that when offered for importation into the United States, medical devices (including In Vitro Diagnostics (IVD)) and radiation-emitting electronic equipment must comply with all relevant US (FDA) regulations.
Foreign establishments must adhere to such relevant import regulations before, during, and after the medical device or radiation-emitting electronic product is imported into the United States or its territories.
The FDA has the power to forbid any product that appears to be in violation of any Federal Food, Drug, and Cosmetic Act laws from entering the American market (FD&C Act).
Import of Medical devices
The medical device importation program is managed by the FDA’s Center for Devices and Radiological Health (CDRH). While companies have to comply with several applicable regulatory requirements, the precise requirements will depend on the category under which they fall. Some companies may be classified as foreign manufacturers while others as initial importers or distributors.
Here’s an overview of the requirements that apply to some of the categories.
Foreign Medical Device Manufacturers:
⦿ Quality System
⦿ Medical Device Listing
⦿ Establishment Registration.
⦿ Labeling
⦿ Premarket Notification [510(k)], unless exempt, or Premarket Approval
⦿ Medical Device Reporting
As part of its initial and updated registration information, a foreign manufacturer is required to name a US agent. FDA inspections, tracking of medical devices (when necessary), and reporting of adverse events are all applicable to international production facilities.
Initial Importers:
According to Title 21 Code of Federal Regulations (21 CFR) Part 807.3(g), an initial importer is any importer who advances the marketing of a device from a foreign manufacturer to the person who makes the device’s final delivery or sale to the user or consumer, but who does not repackage the device or its package or otherwise alter its container, wrapper, or labeling.
A medical device’s initial importer is expected to adhere to the following legal requirements:
⦿ Establishment registration
⦿ Medical Device Tracking (21 CFR 821), where applicable
⦿ Reports of Corrections and Removals (21 CFR 806)
⦿ Medical Device Reporting (MDR) (21 CFR 803)
While there are many requirements that apply, there is also some inspection that happens at the time of importation.
What specifications for medical devices are inspected during importation?
The FDA will check compliance with the following requirements, as appropriate, at the time of importation:
⦿ Registration of the device
⦿ Listing of the device
The FDA requires annual registration from businesses involved in the development and distribution of medical devices intended for commercial sale in the US. The majority of businesses that must register also have to declare the devices they use and the processes that are conducted on these devices at those businesses.
Additionally:
⦿ Premarket Submission guidelines may apply to some medical products (Premarket Notification or Premarket Approval).
⦿ In order to verify that medical devices adhere to relevant standards and/or label requirements, the FDA performs field examinations and analyses samples of medical devices.
⦿ To make sure the producer or product is not subject to detention without physical examination (DWPE) and listed on an import alert, the FDA analyses the import alert database. As an illustration, import warning 89–04 includes foreign producers who do not adhere to the Medical Device Good Manufacturing Practices.
Export requirements For All Medical Device Exporters
Foreign governments and/or customers frequently request documentation of the devices’ FDA-mandated approval or marketing status from companies exporting medical devices from the United States (U.S.) (FDA).
The Export Reform and Enhancement Act of 1996 gave FDA the authority to issue an export certificate and charge a fee for each certification that is issued within 20 working days.
Issuance of an Export certificate
The marketing status of the device determines whether or not it can be sold lawfully in the United States. The status of the device’s marketing determines the export laws that apply to medical equipment.
A product’s regulatory or marketing status in the US is described in an FDA document called an export certificate (U.S.). The export certificate attests in writing that the exported product complies with the necessary specifications.
Certificates come with an embossed gold seal and are printed on counterfeit-resistant paper. The cost associated with each export certificate issued by CDRH is $175.00 for the initial certificate and $85.00 for each successive certificate.
Various export certificates types:
The Center for Devices and Radiological Health (CDRH) is responsible for issuing export certificates to exporters. There are four types of export certificates issued by the CDRH.
⦿ Certificate to Foreign Government (CFG) — A CFG is given for the export of medical devices that are approved for sale under the Federal Food, Drug, and Cosmetic Act in the United States (U.S)
⦿ Certificate of Exportability Under Section 801(e)(1) of the Federal Food, Drug, & Cosmetic Act (FD&C Act) — Devices that meet the requirements of Section 801(e)(1) of the FD&C Act and that may not be legally marketed in the U.S avails the Certificate of Exportability under section 801(e)(1) of FD&C Act.
⦿ Certificate for Exportability Under Section 802 of the FD&C Act — This certificate is issued for medical devices that are not permitted to be sold legally in the United States and that adhere to the FD&C Act’s Section 802 standards.
⦿ Non-Clinical Research Use Only (NCR) — Exporters may use this certificate to send non-clinical research products that are not intended for human use and are lawfully marketed in the United States and exported from the country in line with the FD&C Act.
CDRH will issue an approval or denial to the request submitted by the exporter as per the export requirements.
Other Export documents
Other export documents issued by the FDA include:
⦿ Export Permit Letters — An Export Permit Letter is required for the export of Class III investigational devices, prohibited devices, and/or unapproved devices that have not yet received premarket approval (PMA) from CDRH and do not meet the requirements for a Certificate of Exportability under Section 802 of the FD&C Act. An export permit must also be obtained from the FDA in order to send an unapproved device for investigational use to a country other than those listed in Section 802(b)(1)(A)(i) and (ii) of the FD&C Act.
⦿ Simple Notifications — While enterprises exporting a device under Section 802 of the FD&C Act are not required to get formal authorization before export, they are required to notify the FDA in writing when they first start export of the device.
⦿ Certificate for Device Not Exported from the United States (CDNE): This certificate is given for medical devices manufactured outside of the United States that are identical to FDA-authorized devices on the market prior to May 28, 1976, or approved under the humanitarian device exemption, or granted under De Novo, but are not exported from the United States.
Recordkeeping requirements
Records proving that a device complies with Section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) must be kept by companies exporting devices in accordance with 21 CFR 1.101. (b). All records must be kept for the same amount of time as necessary for records subject to the Quality System Regulation requirements that apply to the device, according to 21 CFR 1.101(b).
If you are a medical device firm wanting to export or import devices, you must know what are the requirements to be met by the device and the establishment. Elexes Medical Consulting is the answer to all your import and export worries!
Elexes is a well-known name in regulatory and quality compliance for medical devices, SaMDs, and IVD and has been involved in enabling manufacturers to meet import and export requirements for a long time now.
For all your concerns related to import and export, contact us at jennifer@elexes.com.
#elexes #import #export #usfda #medicaldevice #healthcare #qualitysystem #regulations #labeling
