Overview of medical device management and regulations in various ries

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• admin
• 2018-12-12

With the rising global medical demand, the overall market size continues to expand. While continuously expanding business boundaries and enriching product structure, domestic and foreign medical device enterprises must strictly abide by relevant laws and regulations to protect the life and health of users.

America

The Food and Drug Administration (FDA), a division of the Department of Health & Human Services (DHHS), FDA is responsible for the comprehensive supervision and management of drugs, food, cosmetics, medical devices, veterinary drugs and other products. The Center for Devices and Radiological Health (CDRH) is the department responsible for medical devices.



FDA is responsible for the overall supervision and management of drugs, food, cosmetics, medical devices, veterinary drugs and other products.

As a worldwide concerned regulatory agency, FDA has experienced more than 100 years of development and established a relatively complete legal and regulatory system. The main laws and regulations related to medical devices are: The Medical Device User Fee And Modernization Act, the Federal Food, Drug and Cosmetic Act, The Drug and Cosmetic Act, the Medical Device Amendments Act, and the Food and Drug Administration Modernization Act Act, Code of Federal Regulation Title 21, etc. And in the United States there are a large number of guidance documents, which are non-mandatory regulatory requirements.


European Union

The Commission of the European Union (EC) is the EU's permanent executive body and the only body with the power to draft laws, implement EU treaties and decisions taken by the Council of the European Union, handle day-to-day affairs, represent the EU in external relations and conduct trade negotiations.

Before 2017, the Council Directive 93/42/EEC on Medical Devices (Council Directive 93/42/EEC on Medical Devices, (Council Directive 90/385/EEC on Active Implantable Medical Devices, Council Directive 90/385/EEC on Active Implantable Medical Devices, AIMD) and Council Directive 98/79/EEC on In Vitro Diagnostic Medical Devices (IVDD).

On May 5, 2017, the European Union officially published the EU Medical Device Regulation (MDR) and the IVD Medical Device Regulation (IVDR) to replace the previous Medical Device Directive.

In order to better protect public health and patient safety, on May 5, 2017, the European Union officially published the EU Medical Device Regulation (MDR) and the IVD Medical Device Regulation (IVDR). MDR and IVDR came into effect on May 26, 2017, and will officially replace MDD, AIMDD and IVDD on May 26, 2020. However, due to the COVID-19 pandemic, the European Commission adopted a proposal on April 3, 2020, to postpone the implementation of MDR and IVDR by one year, that is, from May 26, 2021.

In addition, the European Commission has developed other medical device-related regulations and more than 30 medical device-related guidelines to guide and regulate the management of medical devices.


Japan

The Ministry of Health, Labor and Welfare (MHLW) is the main ministry responsible for health care and social security in Japan. The Ministry of Health, Labour and Welfare first enacted the Pharmaceutical Affairs Law in 1960 to ensure the quality, safety and effectiveness of drugs, cosmetics and medical devices. The law was subsequently amended in 2002 and 2003.



The Japanese Ministry of Health, Labour and Welfare is responsible for the management and supervision of the implementation of the PMD law.

As of November 25, 2014, the Pharmaceutical Affairs Law of Japan (also known as PAL) was amended and renamed as the Quality Assurance, Efficacy and Safety Act on Drugs, Medical Devices, Regenerative Cell Therapy Products, Gene Therapy Products and Cosmetics (PMD Law). The PMD law provides the legal framework for the regulatory regulation of medical devices, in vitro diagnostic reagents, prescription drugs, pharmaceuticals and cosmetics, and regenerative and cell therapy products.

The management and supervision of the PMD law is jointly undertaken by the Japanese Ministry of Health, the Japanese Ministry of Health, Labour and Welfare (MHLW), and the Pharmaceutical and Medical Device Agency (PMDA), including the scientific evaluation of marketing applications for drugs and medical devices and post-marketing safety monitoring.


Australia

In Australia, the Therapeutic Goods Administration (TGA) is the Therapeutic Goods Administration (TGA) of the Australian Government's Department of Health and Ageing, which is responsible for the regulation of therapeutic goods (including medicines, medical devices, genetic technologies and blood products). The TGA carries out a series of reviews and regulatory processes to ensure that treatments offered in Australia meet applicable standards and that the standard of treatment in the Australian community is achieved within a short period of time.

The TGA needs to ensure that treatments offered in Australia meet applicable standards.