Regulatory
Requirements

Our divisions are in compliance with the listed requirements


Hospital Care

Legal basis in the area of quality management: The formal structure of the IMS manual is based on the recommendation of the international standards DIN EN ISO 9001:2008 and DIN EN ISO 13485. In terms of the content and informative value of the processes as demanded in the DIN EN ISO 9001and DIN EN ISO 13485 the “Integrated Management Systems" manual follows the following laws and standards:

  • DIN EN ISO 9001Quality management systems – requirements of the QM-presentation in design, development, production, assembly and maintenance
  • DIN EN ISO 13485 Quality Assurance Systems – medical devices
  • DIN EN ISO 14971 Medical devices – Application of risk management to medical devices
  • ISO/IEC 27001 “Information technology - Security techniques - Information security management systems - Requirements”
  • DIN ISO 45001 Occupational health and safety management systems - Requirements with guidance for use
  • DIN EN ISO 50001 Energy management systems - Requirements with guidance for use
  • Regulation (EU) 2017/745 of the council on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC 
  • Regulation 1935/2004/EC of the Council on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC 
  • Regulation 1223/2009/EC of the Council on cosmetic products 
  • Regulation concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency (ECHA) 
  • European Pharmacopeia (Ph.Eur.) 
  • European Medicines Agency (EMA) Working Parties
  • Regulation 1935/2004/EC of the Council on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC 
  • Regulation 528/2012/EC of the council concerning the making available on the market and use of biocidal products
  • Regulation 1272/2008/EC of the Council on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
  • Directive 93/42/EWG of the Council for medical devices
  • Directive 2014/30/EU on the approximation of the laws of the Member States relating to Electromagnetic Compatibility 
  • Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code to medicinal products for human use 
  • Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to veterinary medicinal products
  • Directive 2012/19/EU of the Council on the waste of electrical and electronical equipment 
  • Directive 2011/65/EU of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment 
  • Directive 89/686/EEC of the Council on personal protective equipment 
  • Directive 2013/C 68/01 of the Council on the Good Distribution Practice of medicinal products for human use
  • Medical Device Law Implementation Act (MPDG - Medizinprodukterecht Durchführungsgesetz) 
  • The Drug Law (AMG) 
  • Narcotics Law (BtMG) 
  • Pharmaceutical-Advertising Law (HWG) 
  • Closed Substance Cycle Waste Management Act (KrWG) 
  • Food and Feed Act (LFGB) 
  • Electrical and Electronical Equipment Act (ElektroG) 
  • Act on the Protection against Hazardous Substances (ChemG)
  • Plant regulation for pharmaceutical enterprises (insofar as they are applicable) (AMWHV) 
  • Plant regulation for pharmaceutical wholesale companies (AM-HandelsV)
  • Cosmetics regulation (KosmetikV) 
  • Packaging Ordinance (VerpackV) 
  • Consumer Goods Ordinance (BedGgstV) 
  • Social Security Statute Book (SGBV) 
  • BSI-Kritis Regulation (BSI-KritisV)
  • Medical Device Single Audit Program (MDSAP)
  • 21 Code of Federal Regulations (CFR) 820 (US Federal Law) (USA)
  • 21 Code of Federal Regulations (CFR) 803, Medical Device Reporting (USA)
  • 21 Code of Federal Regulations (CFR) 806, Reports of Corrections and Removals (USA)
  • 21 Code of Federal Regulation (CFR) 807, Establishment Registration and Device Listing (USA)
  • 21 Code of Federal Regulation (CFR) 821, Device Tracking (USA)
  • Canadian Medical Devices Regulations (CMDR)
  • Japanese Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products and Cosmetics (PMD Act)
  • MHLW MO169 (Japan)
  • Therapeutic Goods (Medical Devices) Regulations 2002 (Australia)
  • RDC ANVISA n. 16/2013 – Good Manufacturing Practices (Brazil)
  • RDC ANVISA n. 23/2012 (reporting of field actions) (Brazil)
  • RDC ANVISA n. 67/2009 – Vigilance (Brazil)
  • Federal Law n. 6360/76 (Brazil)
  • RDC ANVISA n. 56/2001 – Essential Requirements for Safety and Effectiveness (Brazil)
  • 21 Code of Federal Regulations (CFR) 210 (US Federal Law) Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs, general (USA)
  • 21 Code of Federal Regulations (CFR) 211 (US Federal Law) Current good manufacturing practice for finished pharmaceuticals (USA)
  • United States Pharmacopeia (USP), current version
  • Farmacopeia Brasileira, current version 1 
  • RDC 17/2010 (Drug product GMP) (Brazil)
  • Taiwanese Pharmaceutical Affairs Law (Pal)
  • 2014 No. 650 Regulations for the Supervision and Administration of Medical Devices (China)
  • 2014 No. 64 China GMP regulation 
  • Drug Registration Regulation (SFDA Order 28; 2007) (China)
  • Good Manufacturing Practice for Pharmaceutical Products (Revised in 2010) Decree No. 79 of the Ministry of Health (China)
  • Pharmacopoeia of the Peoples Republic of China (Current Revision)
  • 2013 N 913 – Russian Good Manufacturing Practices Regulations 
  • Federal Law N 323-FZ – On Health protection in the Russian Federation 
  • Order No. 737n – Approval of RZN Administrative Regulations of Medical Device Registration (Russia)
  • Decree No. 906 – Changes to the list of all products subject to conformity procedure in Russia 
  • No. 184-ФЗ Federal law on Technical regulations (Russia)
  • Decree No. 1416 – Regulatory Framework for Medical Devices (Russia)
  • No. 214 10/2 – Rules for Technical, Toxicological, and Clinical Tests (Russia)
  • RS-002 Testing Regulations (Russia)
  • MOH Order N 4нApproval of Nomenclature classification for Medical devices and IVDs (Russia)
  • Order 174n – Medical Device Safety, Quality and Effectiveness Monitoring (Russia)
  • Order 175n – On Approval of Medical Device Safety Monitoring Procedure (Russia)
  • Order 12n – Reporting of Adverse Events (Russia)
  • GOST R 51609-2000 – Risk class classification of medical devices only (Russia)
  • MOH No. 89 – Rules for testing medical devices with a measuring function (Russia)
  • Korea Medical Device Act 
  • Regulation on Good Manufacturing Practices (GMP) for Medicinal Products, Ministry of Food and Drug Safety Notice No.2019-52, partially amended on Jun.28, 2019 and Enforced on Jun.29, 2020 (Korea)
  • PIC-Guidelines for Good Manufacturing Practice for medicinal products
  • Guideline of a Good Laboratory Practice
  • Guideline of a Good Clinical Practice
  • ICH-Guideline
  • VICH-Guidelines
  • Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles
  • EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines

Each of the laws and standards is taken into account in its currently valid version.

Connections with the relevant laws and regulations for environmental protection: As for as applicable for local production site the term “Industrial environmental protection“ describes all activities undertaken in connection with environment-compatible production, which are aimed at keeping the air clean, protecting the soil and water, waste prevention, -reduction, -recycling and -disposal, as well as the disposal of the products. It follows the following standards:

  • DIN EN ISO 14001: Environmental management system – specification with instructions for application
  • EMAS (as far as locally applicable)

The laws for the assurance of an environment-compatible production related to immission protection, water management and the recycling and waste management is to be adhered by each production site as far as applicable on national law basis. The immission protection may regulate the installation and operation of plants and machines with environmental impact, both with and without official approval requirement. The set guideline for the operation of such plants and machines is their compliance with state-of-the-art technology standards. Because of this, future developments must already be taken into consideration for the purchase of new plants and machines.

The water management may regulate the duties of waste water treatment and the protection of the groundwater. Technical safety standards as well as cleaning methods, or directives for the prevention of waste water before such water reaches the public sewer system, are therefore introduced and enforced. It may regulate, the protection of the soil and the groundwater during the handling of water-polluting substances.

The regulations covering wastes may regulate the proper avoidance, recycling and disposal of waste, from their production to their final disposal (e.g. waste deposit). 

Conditions laid down by the authorities in the field of environmental protection: The operation of plants and machines with official approval requirement and the implementation of environmental activities may be subject to official authorities’ reviews. These conditions are fixed for each production site in a tabular form in a site-specific environmental Statement as far as applicable. The plant executive personnel ensure the compliance with these conditions.


Aesculap AG 

Fundamental Standards:

  • EN ISO 9001:2015 Quality Management System
  • EN ISO 13485:2016 Medical devices–Quality management systems Requirements for regulatory purposes
  • EN ISO 14971:2019 Risk management
  • EN ISO 14001:2015 Environment management
  • BS OHSAS 18001:2018 Occupational safety - and Healthcare management
  • DIN ISO 45001:2018 Occupational health and safety management systems – Requirements with guidance for use
  • EN ISO 50001:2018 Energy Management

Statutory regulations:

  • AIMD 90/385/EEC (2007/47/EC) Active Implantable Medical Devices
  • AMG Drug Law
  • AM-HandelsV Operational regulation for pharmaceuticals wholesalers
  • ASiG Occupational Safety Act
  • BGV´s Regulations of the Social insurance against occupational accidents
  • CGMP Chinese GMP for Medical Devices
  • CMDR (SOR/98-282) Canadian Medical Device Regulations
  • EMAS (EG 1221/2009) ECO Management Audit Scheme
  • EnEV Energy Saving Regulation
  • EnEG Reduction Law for the Energy in Buildings
  • EnWG Energy Industry Act
  • MDA Medical Device Act including KGMP (Korean Good Manufacturing Practice) 
  • MDD 93/42/EEC (2007/47/EC) Medical Device Directive
  • MDR 2017/745 Medical Device Regulation
  • MPG German Medical Device Law (replaced)
  • MPEUAnpG Medizinprodukte-EU-Anpassungsgesetz
  • MPDG Das Medizinprodukterecht-Durchführungsgesetz
  • MPAMIV Medizinprodukte-Anwendermelde- und Informationsverordnung
  • PAA Pharmaceutical Affairs Act Taiwan
  • PMD Act, MO. 169 Pharmaceutical and Medical Device Act Japan
  • RDC 16:2013 Resolution Brazil
  • TGA Regulations (TG(MD)R) Australian Medical Device Regulations
  • 21 CFR QSR 820 Quality System Regulations of the FDA 

Avitum

Fundamental Standards:

  • EN ISO 13485:2016 Medical devices–Quality management systems Requirements for regulatory purposes
  • EN ISO 14971:2019 Risk management
  • EN ISO 14001:2015 Environment management
  • DIN ISO 45001:2018 Occupational health and safety management systems –Requirements with guidance for use
  • EN ISO 50001:2018 Energy Management

Statutory regulations:

  • CGMP Chinese GMP for Medical Devices
  • CMDR (SOR/98-282) Canadian Medical Device Regulations
  • MDA Medical Device Act including KGMP (Korean Good Manufacturing Practice) 
  • European Directive 93/42/EEC (2007/47/EC) Medical Device Directive (MDD)
  • European Regulation (EU) 2017/745 Medical Device Regulation (MDR)
  • MPEUAnpG Medizinprodukte-EU-Anpassungsgesetz
  • MPDG Medizinprodukterecht-Durchführungsgesetz
  • MPAMIV Medizinprodukte-Anwendermelde- und Informationsverordnung
  • RDC 16:2013 Brazilian Resolution GMP for Medical Devices
  • TGA Regulations (TG(MD)R) Australian Medical Device Regulations
  • 21 CFR Part 820 Quality System Regulations of the FDA
  • European Directives 2001/83/EC and 2008/29/EC on the community code relating to medicinal products for human use
  • European Directive 2003/94/EC on principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
  • European Regulation (EC) 726/2004 for the authorisation and supervision of medicinal products for human and veterinary use
  • European Regulation (EU) 658/2014 for the conduct of pharmacovigilance activities
  • European Directive 2001/20/EC on GCP and Clinical Trials, Changes in the field of pharmacovigilance in the 12th amendment of the German Drug Law
  • European Directive on Falsified Medicines (2011/62/EU)
  • European Guideline 2013/C343/01 on good distribution practice of medicinal products for human use (EU-GDP)
  • European Pharmacopoeia (Ph. Eur.)
  • AMG German Medicinal Products Act and relevant amendments
  • AMWHV German Regulation on Production of Pharmaceuticals and Active Substances
  • AM-HandelsV German Regulation for pharmaceutical wholesalers
  • RDC 210:2003 Brazilian Resolution GMP for Drugs
  • European Regulation on Biocidal Products (EU) 528/2012
  • European Regulation on Cosmetic Products (EC) 1223/2009
  • European Regulation (EU) 2016/425 on Personal Protective Equipment