Certifications & Compliance
As a certified CGM manufacturer, we maintain comprehensive international certifications to serve global markets.
Our Certifications
All our continuous glucose monitor systems are manufactured under strict quality management systems and comply with international medical device regulations.
ISO 13485
Medical Device Quality Management System
International standard for quality management systems specific to medical devices. Demonstrates our commitment to consistent design, development, production, and delivery of safe medical devices.
CE MDR
European Conformity - Medical Device Regulation
Compliance with EU Medical Device Regulation 2017/745, allowing our CGM products to be sold throughout the European Economic Area.
FDA 510(k)
U.S. Food and Drug Administration Clearance
FDA clearance for our CGM devices, demonstrating substantial equivalence to legally marketed predicate devices in the United States.
RoHS
Restriction of Hazardous Substances
Compliance with EU RoHS Directive 2011/65/EU, ensuring our products are free from hazardous substances including lead, mercury, and cadmium.
FCC
Federal Communications Commission
FCC certification for our wireless CGM transmitters, ensuring compliance with U.S. electromagnetic interference regulations.
UL
Underwriters Laboratories Safety Certification
UL safety certification for our CGM charging accessories and electrical components, meeting North American safety standards.
Regional Compliance Guide
Different regions have specific regulatory requirements for medical devices. Here's a quick reference for CGM market access.
European Union
- CE MDR
- ISO 13485
- RoHS
- GDPR Compliance
CE marking required for all medical devices sold in EU/EEA
United States
- FDA 510(k)
- FCC
- UL
- ISO 13485
FDA clearance required before commercial distribution
China
- NMPA Registration
- ISO 13485
- CCC
NMPA (formerly CFDA) registration for domestic sales
Japan
- PMDA Approval
- ISO 13485
- JIS Standards
PMDA approval required for medical device marketing
Southeast Asia
- ISO 13485
- CE or FDA
- Local Registration
Requirements vary by country; CE/FDA often accepted
Middle East
- ISO 13485
- CE
- SFDA/GCC Registration
SFDA registration required for Saudi Arabia
Need Certification Documentation?
Request complete certification packages for your market. Our regulatory team can provide detailed compliance documentation.