Ensure smooth U.S. market entry with our FDA compliance services for medical device exporters. We handle registration, listing, and regulatory documentation.
FDA Compliance Services for Medical Device Exporter
Your medical device business cannot simply be expanded into the U.S. market by innovation and quality and expect to pass through the full regulatory compliance. U.S. Food and Drug Administration (FDA) is very strict in regulating imports of medical devices in order to maintain safety, effectiveness, and transparency. At Compliance Networks, we assist medical device manufacturers, exporters and distributors with all FDA requirements without any delays and no compliance risk and therefore your products reach the market in time and at no risk.
The reason why FDA Compliance is Important to Medical Devices Exporters
Introduction of a medical device in the U.S. is getting into one of the most regulated markets in the world. FDA imposes comprehensive provisions of the Federal Food, Drug and Cosmetic Act (FD&C Act) and regulatory provisions of Part 21 CFR Part 807, Part 820, and Part 803 among others.
The shipments can be prevented by holding up or even denying by the U.S. Customs without appropriate registration, listing of device, labeling, or compliance with the quality system.
Better still, non-compliance is likely to damage your company image and cause great financial damage.
Compliance Networks will keep your products in full compliance to all the relevant FDA regulations – starting with initial classification and all the way to after-market surveillance so that you can concentrate on your main business and leave the complicated regulatory specifications to us.
Our FDA Third Party Services on Medical Device Exporters
Our services are complete and compliance and regulatory solutions specially designed to suit companies that are exporting medical devices into the U.S.
1. Classification of Devices and Determination of the Regulatory Pathway
Each medical device should be properly categorized according to risk (Class I, II or III) before entering the U.S. market.
The classification identifies the nature of premarket submission required i.e., 510(k), PMA, or exemption.
Our company considers the proposed use, technology, and claims of our intended use of your device to find the right regulatory channel.
We develop a transparent plan that will reduce the time-to-market and make sure the complete alignment with the expectations of the FDA.
2. Establishment Registration & Listing of Devices
Any foreign manufacturer, contract sterilizers, specification developers, and original distributors have to make their establishments known to FDA and register their devices.
compliance networks does all the registration and device listing on your behalf – even annual renewals and electronic filings via the FDA FURLS (FDA Unified Registration and Listing System).
We are also your official U.S. Agent, to whom we handle all communications, notifications, and requests to inspect on your behalf by FDA.
3. Premarket Submissions (510 (k), PMA, De Novo)
In case your device needs an FDA clearance or approval, our regulatory experts can write and file the relevant application:
510(k) Premarket Notification of substantial equivalence devices.
Application to new low-to-moderate risk devices: De Novo Classification Request.
Class III devices with high risk PMA (Premarket Approval).
Our assistance is available at each stage of the process, which is data collection, review of technical files, risk assessment, labeling, and FDA correspondence, so that everyone can submit the application smoothly and on time.
4. FDA QSR Compliance & Quality Management System (QMS)
All medical devices manufacturers are required to comply with the Quality System Regulation (QSR 21 CFR Part 820) of FDA.
Our consultants evaluate your current QMS or ISO 13485 system and put it in line with FDA expectations.
We help to develop or enhance:
- Change management system and document control system
- Purchasing and supplier qualification controls
- CAPA systems, production controls and process validation
- Programs on handling complaints, nonconformance and internal audit
- Risk management procedures and design controls
Our assistance will see you having a compliant and inspection ready QMS that will increase regulatory confidence and product quality.
5. Labeling and Packaging Conformance
One of the most frequent causes of the FDA detentions is incorrect labeling.
Our label and packaging are thoroughly reviewed to make sure that your product labeling, directions on use, warnings, and claims satisfy all labeling requirements of the FDA.
Our labeling services cover:
- Labeling devices and art examination
- GUDID submission and Unique Device Identification (UDI) compliance
- Checking of claims and symbols on packaging
- Information about country of origin and importer/distributor
Your labeling is done so that it conveys the right message and is in every aspect within the American regulations.
6. Adverse Event Reporting Post-Market Surveillance
Your compliance with FDA does not cease once your product is in the market.
The Medical Device Reporting (MDR) regulation (21 CFR Part 803) requires manufacturers and importers to follow the product performance and to report some occasions.
The compliance networks assists you with:
- MDR system organization and personnel training
- Negative event analysis and reporting
- CAPM and complaint management
- Planning and reporting on post-market surveillance
We have been proactive in ensuring that you are compliant and safeguard your brand image.
7. FDA Inspection and Audit Preparedness
The FDA frequently examines both foreign and local medical devices plants.
Failure to be ready might lead to Warning Letters, Import Alerts or seizure of shipments.
We conduct pre-inspection audits, training of staff, and document reviews so that when an inspection is to be conducted on your facility, you are ready.
Assuming you already got an FDA Form 483 or Warning Letter, we assist in the preparation and filing of detailed, corrective action responses that would meet the expectations of FDA.
8. Importer & Distributor Compliance
Most exporters do not consider the importance of U.S. importers and distributors in the compliance of FDA.
We assist you and your partners in recognizing their mutual responsibilities as per the FDA law.
Import documents, labeling inspection, establishment registration, and complaint management are only a few of the areas our team can make sure that your whole supply chain is in compliance and agreement.
Why Choose compliance networks
Experienced Specialization: Our group is highly knowledgeable on FDA medical device regulations, and they have the field experience to take you through the tricky regulations.
End-to-End Service: We offer end-to-end service, with product categorization to post-market surveillance.
Personalized Solution: Every project is made unique owing to the technology of your product, the risk, and the purpose of the use.
International Support: We support manufacturers and exporters of any nation to enter the medical device market of the U.S.
Long-term Relationship: Compliance is not the only thing we aim at but a long-term partnership, which means that your company will be in compliance with the regulations as long as they develop.
Get Started on your FDA Compliance
It may appear to be difficult to comply with the FDA regulations particularly with international exporters. By having compliance networks as your regulatory partner, you have a reliable guide on every step to undertake, including first registration to post-market surveillance.
We will assist you in the complexities of U.S. medical device regulations, prevent unsuccessful delays that may cost you a lot of money, and success in entering one of the most challenging markets in the world with smooth compliance.