System introduction | Medical device management system standards in various countries

"Medical device" means any product used for diagnosis, prevention, and treatment of diseases, ranging from wound dressings and cardiac pacemakers to dental chairs, life-support instruments, and in vitro diagnostic reagents. In most countries, the government regulates these medical products so that manufacturers will not jeopardize the health and safety of the public by making shoddy products.

The medical device system regulations are standards and requirements related to quality management and supervision in the medical device industry, established to ensure that medical device manufacturers and suppliers can meet the requirements of relevant standards and regulations in their business processes.

Quality System Certification

In China, enterprises need to complete the "Good Manufacturing Practice for Medical Devices" (GMP) and its corresponding implementation rules, on-site verification guidelines, and complete third-party certification of the quality management system for the medical device industry。

Medical device quality management systems have target market attributes. For the international market, different target markets should comply with the quality management system regulations of different target markets.

The internationally accepted quality management system standard is ISO 13485, but each country has its own regulatory requirements specific to its own characteristics. For example, Korea requires to meet KGMP, Japan requires to meet JGMP, Brazil requires to meet BGMP, Canada requires to meet ISO 13485 or CMDCAS, Australia requires to meet MDSAP for medical devices, and the United States requires to meet QSR 820 ..... However, the overall trend is ISO 13485, the quality management system for the medical device industry.

Medical Device Quality Management System ISO 13485

Medical device quality management systems ISO 13485 is an international standard developed by the International Organization for Standardization. It adds specific requirements for the medical device industry to ISO 9001, and sets stricter control requirements for product identification, process control, and other aspects.

ISO 13485 emphasizes risk management, compliance and continuous improvement and is one of the most commonly used quality management system standards in the medical device industry. It applies to medical device manufacturers, suppliers, and related service providers, requiring these organizations to establish and implement quality management systems to ensure that product design, development, production, sales, and after-sales service meet quality and regulatory requirements.

Obtaining ISO 13485 certification not only improves the quality management level within the organization, but also enhances the ultimate trust of medical workers and end users in the company's products, facilitates international market access for products, and meets the regulatory requirements of many countries and regions. It is very important for medical device manufacturers.

EU Medical Device Directive MDD

In the medical device industry, the European Commission has established three EU Directives to replace the former member states' management systems, harmonizing the relevant regulations for the market entry of related products.

MDD is the common name for the European Union's National Medical Devices Directive 93/42/EEC, which applies to the certification of medical devices marketed in EU member states.

The three commands are:

Active Implantable Medical Device Directive (AIMD, 90/335/EEC), which applies to active implantable medical devices such as cardiac pacemakers and implantable insulin pumps;

The In Vitro Diagnostic Devices Directive (IVD) applies to medical devices for in vivo diagnostic use such as blood cell counters and pregnancy testing devices;

The Medical Devices Directive (93/42/EEC) has a wide scope, including almost all medical devices except active implantable and in vitro diagnostic devices, such as single-use products, contact lenses, blood bags, and catheters; And active medical devices, such as MRI machines, ultrasound diagnostic and treatment devices, infusion pumps, etc;

According to the above directive, after the formal implementation of the directive, only medical device products with the CE mark can be sold on the market in European Union countries. Chinese medical device manufacturers and export companies must comply with the above-mentioned directive and affix the CE mark when selling their products to the EU market, otherwise the products will have difficulty entering the EU market.

EU Medical Devices Regulation MDR

MDR stands for Medical Device Regulation, a new type of medical device regulation issued by the European Union (EU). It was published in April 2017 并and came into force on May 26, 2021, replacing the previous Medical Devices Directive MDD.。

Compared with MDD, the MDR regulation contains many new requirements and provisions, including requirements for the classification, labeling, technical documentation, product registration, supervision, and market access of medical devices, providing a unified regulatory framework for medical devices within the European Union and enhancing the regulation of medical devices to ensure their quality and safety in the market.

The implementation of MDR has had a significant impact on medical device manufacturers and suppliers selling in the European market. Products that have been CE certified under the MDD directive also need to undergo necessary adjustments and reassessments in accordance with the new regulatory requirements in order to obtain MDR CE certification.

Enterprises need to quickly and systematically understand the requirements of MDR and systematically grasp how to adjust the quality management system and CE files to ensure a smooth transition to the new regulations.

In view of the slow progress of the transition from MDD to MDR, the European Union announced the extension of the MDR transition period regulation (EU) 2023/607 in March 2023 to alleviate the pressure on notified bodies. On August 11, 2023, the European Union TEAM-NB officially issued the guidance principles for the signing of the medical device MDD extension conversion agreement -——“NewMDR Transition Timelines and Notified Body Capacity。

医疗器械单一审核程序MDSAP

The medical device single audit program (MDSAP) is a process that allows for the implementation of a single regulatory audit of the quality management system of medical device manufacturers to meet the requirements of multiple regulatory jurisdictions. According to the requirements of MDSAP, the audit organization recognized by the participating regulatory agencies shall organize the audit. ISO 13485 and MDSAP are both certifications focused on quality management systems, with ISO 13485 being the basis for MDSAP. In addition to the ISO 13485 standard, MDSAP is required to meet the regulatory requirements of five participating countries: the U.S. FDA, Australia's TGA, Brazil's ANVISA, Canada's HC, and Japan's MHLW. MDSAP can replace some of the audit and routine inspections of participating countries and obtain market access, so the certification requirements are high.

USA

Replaces routine FDA inspections (except for FDA specific and PMA products).。

Australia

Exemption from TGA audit, support for issuing and maintaining TGA compliance audit certificates.

Brazil

For Class III and Class IV medical devices, it can replace the pre-market GMP inspection of ANVISA and the routine inspection after listing (except for special inspections).

Canada

From 2019, it will be mandatory to replace CMDCAS as the only way for Class II and above products to enter Canada.

Japan

For Class II, Class III and Class IV medical devices, on-site factory audits are exempted.

EHS Management System

EHS management system is an organic integration of environmental management system (EMS) and occupational health and safety management system (OHSMS), which emphasizes the green, occupational safety and sustainable development of enterprises.

At present, the EHS management of each enterprise is in accordance with the dual system of ISO 45001 & ISO 14001. In the management system certification of ISO 14001 and ISO 45001, a prevention management mechanism is established through systematic evaluation of laws, regulations and compliance requirements, to completely eliminate various potential hazards of accidents, environmental and occupational diseases, in order to minimize the occurrence of accidents, environmental pollution and occupational diseases, thereby improving the safety, environmental and health performance of enterprises.

Environmental Management System ISO 14001

ISO 14001 Environmental Management System Certification is a standard for environmental management systems developed by the International Organization for Standardization (ISO). ISO 14001 certification is applicable to any organization, including enterprises, business and related government units.

Certification can prove that the organization has reached the international level in environmental management, ensuring that various pollutant controls in the company's processes, products, and activities meet relevant requirements, which helps the company establish a good social image.

Nowadays, environmental protection issues are receiving increasing attention. Since the International Organization for Standardization (ISO) issued the ISO 14001 environmental management systems standard and several other related standards, they have gained widespread response and attention from countries around the world. More and more enterprises that focus on environmental energy conservation have voluntarily implemented the ISO 14001 environmental management system.

Occupational Health and Safety Management System ISO 45001

ISO 45001 occupational health and safety management system is an international standard for the certification of safety and health management systems, and is the new version of the original Occupational Health and Safety Assessment System (OHSAS 18001), which was published in 2016.

This new standard applies to all organizational occupational health and safety management system standards and is used to help organizations around the world ensure the health and safety of their workers.

It helps to raise the safety awareness of enterprises and employees, improve working conditions, enhance the physical and mental health and safety and health skills of workers, and significantly reduce enterprise cost investment and improve work efficiency. It can generate direct and indirect economic benefits, eliminate trade barriers, promote further alignment with international standards. Establish a good reputation, quality and image, gain certain bonus advantages in bidding, and some local governments will provide financial subsidies to certified enterprises.

Since its establishment in 2018, Vathin Medical has been committed to the construction of a quality management system, constantly pursuing innovation and progress，around quality policies、and goals.，Vathin has obtained all the above-mentioned quality system certificates.

To ensure quality and provide customers with first-class products and services is the sincere commitment of Vathin to customers and society. Vathin will further implement the management system, continuously deepen product quality and service awareness, promote product optimization and upgrading, constantly enhance core competitiveness, and promote high-quality development of the enterprise.

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