Global Certifications & Compliance — FDA | ISO 13485 | CE
At Kongdy Health, we understand that regulatory compliance is the foundation of trust in the medical device and pharmaceutical supply chain. This page provides a transparent overview of our certifications, what each accreditation means for your business, and why our 36+ years of certified manufacturing excellence make us the preferred partner for distributors, brand owners, and healthcare chains worldwide. Every patch leaving our 20,000 sqm facility meets the highest international standards for safety, quality, and efficacy.
Our Certifications – A Mark of Global Quality
Kongdy Health holds three cornerstone certifications that open doors to regulated markets across North America, Europe, Asia, and beyond. Below we explain each certification, its regulatory significance, and its direct benefit to you as a buyer.
FDA Registration (U.S. Food and Drug Administration) – Since 1989
What it means: Kongdy Health has been registered with the U.S. FDA since 1989, demonstrating continuous compliance with the stringent quality system requirements (21 CFR Part 820) for medical device manufacturing. Our facility and processes are subject to routine FDA inspections and adhere to Current Good Manufacturing Practices (cGMP).
Why it matters for buyers: FDA registration is a prerequisite for importing transdermal patches into the United States. It assures you that our products meet the FDA’s rigorous standards for safety, labeling, and performance. For U.S.-based distributors and healthcare chains, this certification eliminates regulatory barriers and accelerates time-to-market.
ISO 13485:2016 – Quality Management System for Medical Devices
What it means: ISO 13485 is the international standard specifically designed for medical device manufacturers. Kongdy Health is certified to ISO 13485:2016, covering the entire lifecycle from design and development through production, storage, and distribution. Our 20,000 sqm facility operates under a robust quality management system that emphasizes risk management, traceability, and continuous improvement.
Why it matters for buyers: This certification is your guarantee that every patch we produce — from raw material sourcing to final packaging — follows documented, audited procedures. It reduces your supplier audit burden and ensures consistent product quality batch after batch, even at scale.
CE Marking (European Conformity) – Access to the European Market
What it means: Our transdermal patches carry CE marking under the Medical Device Regulation (MDR) or relevant directives, indicating conformity with European health, safety, and environmental standards. CE marking is mandatory for placing medical devices on the market in the European Economic Area.
Why it matters for buyers: CE marking opens the door to 30+ countries in Europe without additional national certifications. It signals that our patches have undergone conformity assessment procedures, including clinical evaluation and biocompatibility testing. For European brand owners and distributors, this means seamless importation and regulatory compliance.
Certification Summary Table
| Certification | Regulatory Body / Standard | Year Achieved | Key Requirement | Market Access |
|---|---|---|---|---|
| FDA Registration | U.S. Food and Drug Administration | 1989 | 21 CFR Part 820 (QS Regulation) | United States |
| ISO 13485:2016 | International Organization for Standardization | 2003 (recertified regularly) | Quality management for medical devices | Global (120+ countries) |
| CE Marking | European Union (MDR 2017/745) | 2005 (updated per MDR) | Conformity assessment, clinical evaluation | European Economic Area |
Why Partner with Kongdy Health
Beyond certifications, Kongdy Health brings decades of specialized expertise and manufacturing capability that directly benefit your business. Here is what sets us apart:
- 36+ years of R&D experience: Our in-house R&D team has been formulating and testing transdermal patches since 1986, giving us unmatched knowledge in drug-in-adhesive, matrix, and reservoir technologies.
- FDA certified since 1989: We were among the first Chinese transdermal patch manufacturers to achieve FDA registration, and we have maintained it continuously for over three decades.
- ISO 13485 compliant facility (20,000 sqm): Our state-of-the-art production base is designed for medical device GMP, with controlled environments, validated processes, and full traceability.
- Low MOQ – 10,000 pieces: We understand that new market entries and product launches require flexibility. Our minimum order quantity of 10,000 pieces allows you to test markets without overcommitting inventory.
- Shipping to 120+ countries: Our logistics network covers regulated and emerging markets alike, with experience in customs clearance and documentation for medical devices.
- OEM/ODM, private label, custom formulation: Whether you need your own branded patch, a custom drug formulation, or a turnkey private label solution, our team manages the entire process from concept to commercial shipment.
“Kongdy Health’s certifications are not just wall plaques — they are the backbone of our commitment to global health. Every patch we produce is backed by 36 years of regulatory compliance and manufacturing excellence.” — Quality Assurance Director, Kongdy Health
Contact Us for OEM/ODM Inquiries
Ready to bring a certified transdermal patch to your market? Our business development team is standing by to discuss your project requirements, from custom formulations to private label packaging. We offer end-to-end support including regulatory documentation, stability testing, and logistics planning.
Email: info@kongdyhealth.com
WhatsApp: +86 123 4567 8901
Let Kongdy Health be your trusted partner in global transdermal patch manufacturing. Contact us today to start the conversation.