Certification
B. Braun Medical Industries Sdn. Bhd [Company registration number: 197401001922 (19051-H)] in Penang, Malaysia, is awarded the ISO 14001: 2015 Environmental Management System certificate by Lloyd’s Register Quality Assurances Ltd in April 2017.
In addition, TUV SUD (Malaysia) Sdn. Bhd. has also awarded Good Distribution Practice for Medical Device (GDPMD) to B.Braun Medical Industries as a local authorized representative (LAR) for Dental devices, Electro mechanical medical devices, hospital hardware, In vitro diagnostic devices, non-active implantable devices, reusable devices, single use devices, healthcare facility products and adaptations and medical sofware on 8th May 2017.
Besides that, the company’s operations are organized into four divisions - Hospital Care, Aesculap, Out Patient Market, and B. Braun Avitum. 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
