Certifications

Full International Certifications
and Compliance

Certifications

Hartalega’s quality standards, management systems and exemplary regulatory compliance, all contribute to the global success of the company. Our capabilities have been assessed and certified by the following international governing bodies.

iso-9001
ISO 13485:2003
EN ISO 13485:2003/AC:2009
Confirmation Letter for GMP Audit
EC Certificate
ISO 14001:2004
UL Certification
ISEGA Food Contact Test Certification (German)
Registration Certificate for Medical Device
CGSB Certification of Medical Examinations Gloves program manual
510(k) Approval
PPE Cert
ANVISA