Certifications and Compliance: Your Global Manufacturing Partner

I. Global Market Access: The Passports to International Trade

We understand that seamless global market entry is crucial for your brand. We have secured registrations and certifications from the most authoritative bodies, guaranteeing your custom products comply with the standards of major international markets.

The Gold Standard for the US Market: Dual FDA Certifications

We hold both 2026 FDA Medical Device registration and 2026 FDA OTC Drug registration.

This dual certification means our products and facilities fully comply with the stringent requirements of the U.S. Food and Drug Administration for both medical patches and non-prescription topical drugs. We are equipped to meet your export needs for both product classifications.

Mandatory for Europe: CE Mark & EU Authorized Representative

We have secured the CE Certificate and established a robust European Authorized Representative (EU Rep) system.

The CE Mark is the mandatory passport for products entering the European Union. Our EU Representative guarantees that your products maintain compliance, traceability, and safety surveillance within the European Economic Area.

II. International Quality Management: Details Define Excellence

Beyond basic market entry, we are committed to delivering exceptional manufacturing quality, safeguarding your brand reputation with the highest international standards.

The Industry Foundation: ISO Quality Management System

We are ISO Certified, demonstrating that we maintain an efficient and stable international quality management system across design, development, production, and service.

The ISO certification is the fundamental and most widely recognized acknowledgment of quality, serving as the cornerstone for the standardization of our internal processes.

The Guarantee of Superior Manufacturing: Good Manufacturing Practice (GMP)

For clients who demand meticulous detail and production integrity, we adhere strictly to GMP (Good Manufacturing Practice) guidelines.

We strictly follow GMP requirements in our manufacturing management, maintaining tight control over every step from raw material procurement to final dispatch, providing you with uncompromising quality assurance. (GMP documentation is available upon request).

III. Our Quality Commitment

Your product safety and brand reputation are our primary responsibilities. By choosing My Kang, you are selecting a partner supported by the comprehensive framework of dual FDA, CE, and ISO systems, guaranteeing the highest global standards for compliance, safety, and production efficiency.

We remove global trade barriers, allowing you to focus entirely on market expansion and brand growth.