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Certification

The following divisions are in compliance with the listed regulatory requirements:


Hospital Care
US:
21 Code of Federal Regulations (CFR) 820 Quality System Regulation (QSR) for Medical devices Parts 210-211 for drugs and related regulations, also known as FDA (Food and Drug Administration) requirements

European Union:
EU directive 93/42/EEC of the council concerning medical devices
EC Guide to Good Manufacturing Practice for Medicinal Products (drugs)
ISO 9001 Quality management systems
ISO 13485/EN 46001 Particular requirements for medical devices
ISO 14001 Environmental systems
Eco-audit directive 1836/93
and related guidelines like Good Clinical Practice and Good Laboratory Practice

as well as to national laws.

Aesculap AG
US:
21 Code of Federal Regulations (CFR) 820 Quality System Regulation (QSR) for Medical devices and related regulations, also known as FDA (Food and Drug Administration ) requirements

Canada:
Medical Device Regulations

European Union:
EU directive 93/42/EEC of the council concerning medical devices
EU-directive 2003/32/EG Anforderungen an unter Verwendung von Gewebe tierischen Ursprungs hersestellte Medizinprodukte
EU-directive 2002/96/EG über Elektro- und Elektronik-Altgeräte
sowie die zutreffenden nationalen gesetzlichen Umsetzungen der EU-Richtlinien
ISO 9001:2000 Quality management systems requirements
ISO 13485:2003 Particular requirements for medical devices
ISO 14001:1996 Environmental systems
Eco-audit directive 1836/93
and related guidelines like Good Clinical Practice and Good Laboratory Practice
OHSAS 18001:1999 Arbeitsschutzmanagement

as well as other national laws in Japan, Korea, Taiwan, Brazil etc.

B. Braun Avitum
US:
21 Code of Federal Regulations, Subchapter H Medical Devices der Food and Drug Administration

European Union:
Directive 93/42/EWG of the Council for Medical Devices
DIN EN ISO 9001:2000 Quality Management Systems
DIN EN ISO 13485:2003 Quality Management Systems for Medical Devices
ISO 14001 Environmental Management Systems
Eco-Audit-Directive 1836/93
National laws and directives for medical devices and medicinals in the countries where the products are distributed
Applicable standards for medical devices and medicinals for the extracorporeal blood treatment.

Out Patient Market (OPM)
European Union:
EU directive 93/42/EEC of the council concerning medical devices
EU directive 98/79/EEC of the council concerning In-Vitro-Diagnostica
EU directive 93/35/EEC of the council concerning cosmetic
EU directive 1999/21/EEC of the council concerning dietary food EU directive 98/8/EEC des Rates über das Inverkehrbringen von Biozid-Produkten

German laws:
AMG- Arzneimittelgesetz (Pharmaceutical law)
MPG- Medizinproduktegesetz (Law of medical devices)
LMBG- Lebensmittel- und Bedarfsgegenständegesetz (Law of food and consumer goods)

Quality-related standards:
ISO 9001 Quality management systems
ISO 13485 Particular requirements for medical devices