The main tasks of BfArM (the German Federal Institute for Drugs and Medical Devices) include the authorisation of finished medicinal products,  registration of homeopathic drugs, monitoring of risks related to medicinal products and medical devices (for example pacemakers, apparatuses for radiation therapy and prosthetic devices) as well as the monitoring of legal traffic in controlled substances.

The ZLG (Central Authority of the Laender for Health Protection with Regard to Medicinal Products and Medical Devices) is the central coordination unit of the 16 German federal states regarding medicinal products for human and animal use. It is a notifying authority for medical devices and concerned with the accreditation of laboratories, certification bodies and conformity assessment bodies. The ZLG collaborates internationally regarding the control of medicinal products.

On its website, the DIMDI (German Institute of Medical Documentation and Information) offers access to 70 databases with about 100 million records on the fields of medicine, drugs and toxiology. Additionally, extensive information about the German health care system is available.

BVMed (German Medical Technology Association) is a trade association representing about 200 manufacturers and service providers of medical devices.

European Commission
The European Commission provides guidelines relating to medical devices, which aim at the promotion of a common approach in matters regarding medical devices within the EU. On the Commission’s website the most recent versions of documents issued in this field can be obtained.

The Food and Drug Administration (FDA) is an agency of the US Department of Health and Human Services and regulates dietary supplements, drugs, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics in the United States. It is responsible for protecting the public health and assuring the safety and efficacy of human and veterinary drugs, biological products, medical devices and products that emit radiation. This extends to both domestic and imported products.

The DEKRA Certification competence centre provides global certification services for quality, environment, risk and data protection management systems, as well as the certification of pharmaceutical products. Its services are available in over 50 countries.

LGA InterCert
LGA InterCert is a subsidiary of the LGA consortium in Nuremberg and is one of the most-experienced certfication companies in Germany. It provides individual solutions in a broad range of certification fields and is active both on the national and international level.

TÜV Rheinland
TÜV Rheinland is a member of the TÜV Rheinland Group, a global leader in independent testing and assessment services, which offers its services in over 60 countries. TÜV Rheinland is a Notified Body for all medical products and certifies both products and quality management systems.

TÜV SÜD is a major international service group operating in the business segments of industry, mobility and people, it is represented at over 600 locations. TÜV SÜD Product Service is not only Notified Body for all relevant EU-directives but is currently also the only NRTL (Nationally Recognized Testing Laboratory) outside North America which is authorised to test and certify products for the US and Canadian market.

TÜV NORD CERT GmbH is the lead company within the Certification Division of the TÜV NORD Group. Their main activity is the provision of comprehensive inspection, testing and certification services, based on national and international regulations and standards. As one of the largest international certification bodies their services are available in over 70 countries.

mdc (medical device certification GmbH), a ZDH-ZERT company, is one of the few Notified Bodies in Germany which can offer the manufacturers of medical devices and in vitro diagnostic devices the necessary certifications for the European market. Mdc has a world-wide network of partners, its experts serve in international and European standards committees and working groups of the EU Commission. In the past, ZDH-ZERT concentrated mainly on the certification small and middle-sized companies, especially in the field of health services and surgical instruments.

The DQS (German Registrar for Management Systems) has the main goal of strengthening its customers’s competitiveness by neutrally and independently assessing their quality skills. In order to achive this, the DQS assesses management systems and processes on the basis of more than 70 nationally and internationally recognized standards and specifications.