Quality & Compliance
Internationally Certified Quality. Across Every Division.
ISO 13485, GMP, FDA, CE Marked, NSF, HACCP, ISO 22000, and Halal — comprehensive regulatory credentials supporting market entry in 100+ countries.
Certifications by Division
Each division holds the credentials its market requires.
Golden Daily
Supplements
- GMP Good Manufacturing Practice
- HACCP Hazard Analysis Critical Control Point
- ISO 22000 Food Safety Management System
- NSF Dietary Supplement Quality
- Halal Indonesia Certified
- FDA U.S. Food and Drug Administration
Golden Time
IVD Diagnostics
- ISO 13485 Medical Device Quality Management System
- CE Marked (IVDD / IVDR) EU In Vitro Diagnostic Regulation
- FDA In Progress
Golden Care
Medical Devices
- ISO 13485 Medical Device Quality Management System
- CE Marked EU Regulatory Compliance
Manufacturing Standards
Built to international medical device and food safety standards.
ISO Class 8 Cleanroom
100,000-grade
Established 2012. Controlled-environment manufacturing for IVD diagnostic products with continuous particle monitoring and access-controlled entry.
GMP Production Lines
Good Manufacturing Practice
GMP protocols across supplement and medical device production. Documented batch records, equipment qualification, and personnel training.
ISO 13485 Compliance
Medical Device QMS
Medical device quality management for both IVD diagnostics (Golden Time) and home medical devices (Golden Care). Documented design controls, risk management, and post-market surveillance.
Documentation Support for Your Market Entry
Our team prepares technical files and product documentation appropriate for your target market — drawing from our ISO 13485, CE, GMP, HACCP, ISO 22000, NSF, FDA, and Halal credentials. Contact us to discuss the specific documentation requirements for your region.
Need Specific Documentation?
Request certificates, technical files, or compliance summaries. Our quality team responds within one business day.