Quality & Compliance
Medten is registered with the U.S. FDA as an initial importer and distributor of medical device accessories and repair parts.
Medten USA distributes products from multiple manufacturers. Manufacturer FDA registration and product documentation are available where applicable. Applicable certifications and clearances are manufacturer- and product-specific.
Who we are
FDA Registration as an Initial Importer
Medten is an FDA-registered initial importer. As a distributor, Medten fulfills its listing obligations by providing each device's manufacturer name and address.
Medten USA distributes products from multiple manufacturers. Manufacturer FDA registration and product documentation are available where applicable. Applicable certifications and clearances are manufacturer- and product-specific.
Verify our registration status in the FDA Establishment Registration & Device Listing database — search for "Medten" to confirm our active initial importer registration.
Our commitment
Our Compliance Commitment
Medten is committed to supplying medical device accessories and repair parts under controls that meet our obligations as an FDA-registered initial importer. We maintain device complaint files and distribution records, cooperate with manufacturers on corrections and removals, and stand behind the products we distribute.
Our process
Our Distributor Quality Process
Medten's quality and compliance workflow runs as a single closed loop — from supplier management through complaint handling and corrections.
1. Supplier Management
Manufacturer identification (21 CFR 807)
2. Storage Control
Segregated, controlled storage (21 CFR QMSR820 7.5.11)
3. Distribution Records
Consignee, quantity, date, control number (21 CFR QMSR820 7.2.2, 7.5.1, 7.5.9, 820.35, 820.45, 7.5.11)
4. Device Tracking
Tracking-order cooperation (21 CFR 821)
5. Complaint Handling
Complaint file & escalation (21 CFR 820.35)
6. Corrections & Removals
Notify downstream on recalls (21 CFR 806)
Corrections feed back into supplier management — closing the quality loop.
Supplier management
Supplier Management
Medten records the name and address of the manufacturer for every device it imports, fulfilling its listing obligations as an initial importer (21 CFR Part 807).
As a voluntary practice, Medten qualifies every upstream manufacturer before first purchase and re-verifies compliance annually — collecting each supplier's ISO certificate (ISO 13485 / ISO 9001) and 510(k) or exemption evidence before onboarding. Our key manufacturing partners — including Orantech and Beta — each pass this annual review.
What we verify
- Quality system compliance Supplier holds a valid ISO 13485 or ISO 9001 certification, or an equivalent quality system declaration, renewed annually.
- FDA registration & clearance Supplier provides its FDA registration number (where applicable) and 510(k) or exemption evidence for supplied devices.
- Facility & storage conditions Storage areas have adequate lighting, ventilation, temperature control, and security.
- Product segregation A quarantine area is maintained for expired, damaged, or mislabeled product.
- Incoming & outgoing inspection Each received lot is visually inspected; each shipment's product identity and delivery address are verified.
- Record retention All records shall be retained for the period required by FDA applicable regulations, and shall be readily available for FDA inspection upon request.
Operational controls
Storage Control
ConditionalWhere Medten handles product physically, it keeps segregated, environment-controlled storage with quarantine areas for non-conforming product (21 CFR QMSR820 7.5.11).
Segregation & Quarantine
Expired, damaged, or mislabeled product is immediately moved to a controlled quarantine area and excluded from saleable inventory.
Receiving Check
Every received lot undergoes a visual check of outer packaging and labeling before acceptance into storage.
Distribution records
Distribution Records
RequiredMedten maintains distribution records for every shipment, containing or referencing the following (21 CFR QMSR820 7.2.2, 7.5.1, 7.5.9, 820.35, 820.45, 7.5.11):
Consignee
The name and address of the initial consignee.
Device & Quantity
The identity and quantity of the devices shipped.
Shipment Date
The date the devices were shipped.
Control Number
Any control number used for traceability.
Before dispatch, product identity and the recipient's delivery address are matched against the sales order to prevent mis-shipment.
Traceability
Device Tracking
UDI labels are applied by the device labeler — typically the manufacturer. As a distributor, Medten adds only its own name and address. Where a device falls under an FDA tracking order, Medten cooperates in maintaining device tracking records as required by 21 CFR Part 821.
Look up a device: search the FDA's AccessGUDID database to review the UDI and labeling information for devices we distribute.
Post-market surveillance
Complaint Handling
Medten establishes and maintains a complaint file for every device complaint received (21 CFR QMSR 820.35 and 21 CFR Part 803). When a reportable event is identified, Medten promptly notifies the device manufacturer, who holds the reporting obligation.
If you have experienced a problem with a device supplied by Medten, submit a complaint and our quality team will respond and escalate as required.
Submit a complaint: email info@medten.com — our complaint handling procedure is documented and available on request.
Continuous improvement
Corrections & Removals
Medten cooperates with manufacturers on corrections and removals, notifying downstream customers as required by 21 CFR Part 806. When a quality issue originates with an upstream product, Medten feeds complaint and event information back to the manufacturer and tracks the completion of their corrective action.
Report
Complaint and event information is fed back to the manufacturer where the issue is upstream.
Coordinate
Medten coordinates with the manufacturer on corrections or removals and notifies downstream customers.
Track
Medten tracks the manufacturer's corrective action through to completion.
Request documentation
Request Documentation
Questions about our quality system, supplier requirements, or a device complaint? Our team is ready to help. Documentation availability depends on the product and manufacturer.
We can provide the following on request
- Supplier ISO / FDA compliance statements
- Product specifications
- Warranty information
- 510(k) summaries (where applicable)
Use the inquiry form and include the product model or Medten SKU. Submitting a request does not mean a certificate or other record is on file for every product.
FAQ
Frequently Asked Questions
Answers about compliance, documentation, product origin, warranty, and complaint handling.
Are Medten's parts compliant and legal to resell?
Medten is registered with the U.S. FDA as an initial importer and distributor of medical device accessories and repair parts, and we source from qualified manufacturers. You can verify Medten's registration status in the FDA establishment registration database. Product-level certifications and clearances remain manufacturer- and product-specific.
Can I get the compliance paperwork (510(k), certificates, CoC) I need to resell or service?
On request we can provide supplier ISO/FDA compliance statements, product specifications, warranty information, and 510(k) summaries where applicable. Email info@medten.com or use the inquiry form with the product model, and we will send the relevant documentation when it is available.
Are your parts OEM (original) or aftermarket/compatible?
The largest portion of our catalog is third-party compatible products, and we continue to add original (OEM) products. Each product page lists Product Type so you can confirm whether an item is compatible or original before ordering.
What warranty and return policy do you offer?
Warranty terms vary by product category. See warranty information on the Downloads page for category-specific terms. With inventories in Texas and California, we support fast delivery and returns where the published policy allows.
What happens if there's a problem — complaint, return, or recall?
Medten maintains a documented complaint file and, where a reportable event is identified, promptly notifies the originating manufacturer. To report a problem, email info@medten.com and our team will guide you through the process.
Do certifications apply to every product sold by Medten?
No. A certificate applies only to the manufacturer and the products covered by that document. Medten sells products from more than one manufacturer, including products that are not made by Orantech.
Is FDA registration the same as FDA 510(k) clearance or FDA approval?
No. FDA manufacturer registration and device listing are not FDA 510(k) clearance or FDA approval. The FDA does not certify medical devices. Check the product page and the manufacturer documentation for the specific product.
Resources
Explore Our Resources
Additional Medten resources for documentation, support, and procurement education.
Downloads
Warranty terms, manufacturer certificates, and product brochures.
View available documentationSupport
Contact options for product questions and service requests.
Visit our support centerFAQs
Answers on compatibility, lead times, returns, and warranty.
Browse frequently asked questionsBlogs
Expert insights on medical equipment and patient monitoring.
Explore our medical equipment resourcesLearn
Guides for biomedical engineers and procurement teams.
Explore learning resources
