Regulation compliance
for medical devices.
Easily navigate complex and strict regulations. Registrar Corp offers a comprehensive list of compliance services for medical device importers and exporters in the U.S. and abroad.
Medical Device Industry
Services
With over 20 years of regulatory compliance experience, we’ve got the expertise to help you prepare your devices for the U.S. and international markets. Our medical device compliance offerings include FDA and Health Canada registration, licensing and listings, master files submission, and adverse event reporting.
FDA Registration and Listings
Keep up with your annual FDA registration and stay on top of U.S. regulations. We support medical device facilities with FDA facility registration and renewal, registration fees, and medical device listings. If you are exporting products to the U.S., we can also manage communication and represent your facility as your
U.S. Agent.
UDI and GUDID Services
Meet FDA standards for medical device unique device numbers (UDIs). Most medical devices sold in the U.S. must include a UDI for each device characteristic on labels, packages, and in some cases, on the device itself. We’ll guide you through gathering and preparing the required data and submitting your UDIs to the GUDID database, all with one-on-one professional support.
Electronic Medical Device Reporting (eMDR)
Submit adverse event reports quickly and efficiently. FDA now requires medical device manufacturers and importers to submit adverse event reports in electronic format. We will work with you to convert mandatory initial and supplemental adverse event reports into the eMDR format and submit them to FDA’s Electronic Submission Gateway (ESG) on your behalf.
Medical Device Master Files (MAFs)
Need to submit a MAF as part of your medical device application? Registrar Corp’s MAF services include submission preparation and amendment assistance, MAF conversion to electronic common technical document (eCTD) format, and a secure online portal to access your submission documents at any time. We can also submit MAFs for you to 18 regulatory agencies worldwide, including FDA and Health Canada.
Label and Product Review
Assure proper labeling of your medical devices. FDA has a long list of labeling requirements for all medical devices, such as warning statements, adequate instructions for use, and Unique Device Identifiers (UDIs). Our team of regulatory specialists can review and report on your medical device labels and assets, determine which regulations you must follow, and suggest or make recommended updates.
Health Canada
All medical devices meant for commercial importation must meet Health Canada’s robust regulatory requirements. Registrar Corp can help you determine which class your device falls into for regulation purposes, apply for, update, and renew the appropriate license(s), facilitate license fees, and act as your Regulatory Correspondent.
Other Services
Registrar Corp offers additional regulatory services for medical device facilities, including detention assistance, support in case of detentions due to an import alert.
Import Alert Support
Manage Detentions Without A Physical Examination (DWPE) accurately and completely. Registrar Corp can support companies with detained shipments in multiple ways: determine instances of potential noncompliance, document corrective action, and submitting a complete petition for removal.
Detention Assistance
Has your device shipment been detained due to misbranding, adulteration, or an import alert? We can work with you to resolve it by gathering evidence of compliance and assisting you to submit a testimony of admissibility or reconditioning request.
Ship safe, compliant medical devices
worldwide.
Frequently Asked Questions
Owners or operators of establishments involved in producing and distributing medical devices intended for the U.S. market must register annually with FDA and pay an annual registration fee.
In addition to registering with FDA, most owners or operators of medical device establishments must also submit a list of all devices during their annual registration renewal.
- U.S. Facilities
- Initial importers must identify the manufacturers of the devices they are importing.
- A device must be listed if they fall under the any of the following:
- Contract Manufacturer
- Contract Sterilizer
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U. S. manufacturer of export only devices
- Non-U.S. Facilities
- Must list devices, provide a U.S. Agent, and identify importers.
In most cases, all medical device establishments required to register with FDA must also submit a complete list of medical devices manufactured for commercial distribution in the U.S. market.
All facilities that fall under any of the following functions:
- Contract Manufacturer
- Contract Sterilizer
- Foreign Exporter
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U.S. manufacturer of export only devices
Medical device establishments must list any medical device made in the establishment and the activities the device is meant for.
- Company function (activity)
- Device product code
- Proprietary names
- Importer information
A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or the National Medical Products Association (NMPA) in China.