Global Certifications & Compliance

Kongdy Health holds worldwide regulatory certifications — FDA, ISO 13485, and CE — ensuring every transdermal patch from our 20,000 sqm facility meets the highest international safety and quality standards. 36+ years of certified manufacturing excellence.

📄 Request Certificates (PDF) 📞 Contact Compliance Team

Certification	Standard / Body	Market Access	Verification / Download
FDA Registration	U.S. FDA (21 CFR 820)	USA, Canada, Latin America	View Certificate ↗ · FDA FEA Database ↗
ISO 13485:2016	International Medical Device QMS	Global (180+ countries)	View Certificate ↗
CE Marking (MDR)	EU MDR 2017/745	EU, UK, Middle East, Asia	View Certificate ↗

📜 FDA Registration (U.S. Food and Drug Administration)

Registered since 1989 — Kongdy Health has maintained continuous FDA registration under 21 CFR Part 820 for over 36 years, demonstrating an uninterrupted track record of compliance with the U.S. FDA quality system requirements for medical device manufacturing. Our facility and processes are subject to routine FDA inspections.

FDA Registration Certificate - Kongdy Health since 1989

Buyer benefit: FDA registration is a non-negotiable requirement for importing transdermal patches into the United States. Our active registration eliminates regulatory barriers and accelerates your time-to-market for U.S. distribution.

⬇ Request FDA Certificate (PDF)

✓ Verified via FDA FEA Database

📜 ISO 13485:2016 — Quality Management System for Medical Devices

Globally recognized standard — Kongdy Health is ISO 13485:2016 certified, covering the entire lifecycle from design and development through production, storage, and distribution. Our 20,000 sqm facility operates under a robust QMS emphasizing risk management, traceability, and continuous improvement.

ISO 13485 2016 Certificate - Kongdy Health

Buyer benefit: ISO 13485 certification guarantees every patch follows documented, audited procedures — from raw material sourcing to final packaging. Reduces your supplier audit burden and ensures batch-to-batch consistency at any scale.

⬇ Request ISO Certificate (PDF)

📜 CE Marking (European Conformity — MDR 2017/745)

Full EU MDR compliance — Our transdermal patches carry CE marking under the European Medical Device Regulation (EU 2017/745), providing unrestricted access to the European Union, UK, and MDR-recognized markets across the Middle East and Asia.

CE Marking Certificate - Kongdy Health EU MDR

Buyer benefit: Our CE marking covers patches classified under MDR including pain relief, cooling, weight loss, sleep, vitamin, and mosquito repellent. Streamlined import and distribution across all EU member states.

⬇ Request CE Certificate (PDF)

Frequently Asked Questions

Regulatory compliance questions answered for global buyers evaluating Kongdy Health as their OEM/ODM partner.

Can Kongdy Health provide the complete technical dossier for our local FDA OTC drug listing?

Yes. As a registered FDA facility with 36+ years of compliance history, Kongdy Health can provide comprehensive technical documentation including Drug Master Files (DMF), stability studies, and impurity profiles to support your OTC drug listing with the FDA. Our regulatory team assists with the entire submission process at no additional cost for qualified OEM/ODM partners.

Are your CE marked patches compliant with the latest EU MDR 2017/745 regulations?

Absolutely. All our CE marked products comply with the latest EU Medical Device Regulation (MDR 2017/745), which replaced the older MDD directive. Our patches are classified and certified under the appropriate MDR annexes, and we maintain ongoing vigilance reporting and post-market surveillance documentation as required by the regulation.

Do you offer regulatory support for new markets beyond FDA, ISO, and CE?

Yes. Our regulatory affairs team actively supports product registration in over 120 countries including Canada (Health Canada), Australia (TGA), Saudi Arabia (SFDA), Japan (PMDA), and Southeast Asian markets. We provide country-specific dossiers, free sale certificates, and liaise with local regulatory representatives as needed.

How do you ensure batch-to-batch consistency across large-volume OEM orders?

Our ISO 13485:2016 QMS mandates rigorous incoming raw material inspection, in-process quality checks, and finished product testing for every batch. We maintain full traceability from raw material lot numbers to finished product serial numbers. Each batch includes a Certificate of Analysis (COA) and retains samples for the full product shelf life.

Can we audit your facility to verify these certifications in person?

We welcome and encourage facility audits. Our 20,000 sqm ISO 13485 certified facility in Zhoukou, Henan, China, is open for scheduled buyer audits. We can also arrange virtual audits via video walkthrough for initial qualification. Simply submit your request below, and our quality team will coordinate the audit schedule.

Need Certified Patches for Your Market?

Submit your requirements below. Our compliance manager will provide a preliminary registration and sampling plan within 12 hours. All inquiries are protected by NDA.

Send Us Your Inquiry

Tell us your requirements — we usually respond with a preliminary quotation and sampling plan within 12 hours.

🔒 100% Secure & Confidential. We sign NDA within 24 hours for qualified buyers.