Product Safety - Japan

JETRO, the Japan External Trade Organization, is Japan's semi-governmental organization for trade and investment. It offers in a number of handbooks up-to-date and detailed information on Japanese standardsStandards usually refer to the rules of engineering. There are also, however, standards relating to other areas. One such area is accountancy, which is subject to the International Accounting Standards (IAS). Standards promote rationalisation, make quality assurance possible, encourage safety both inside and outside the workplace, harmonise testing methods in such areas as environmental protection, and generally help create a consensus regarding the economy, technology, science, administration and the general public.

Standards also promote the free movement of goods and services. Within the European Union (EU) and the European Economic Area (EEA), the application of harmonised standards makes it easier to prove conformity with basic health and safety requirements (CE marking) for a large number of industrial products. Standards are not created at state level, but by the very people who need them within the fields of finance, consumer rights, administration and science. Representatives from these fields invest their time and expertise in creating standards to suit both their own interests and the broader interest.

There are Swiss standards (SN), European standards (EN), international standards (ISO and IEC), as well as what are known as works standards. Switzerland’s body of standards (well in excess of 10,000 documents from every industry and sector of the economy and society) is maintained by the Swiss Association for Standardization (SNV). and regulations online.

Contact: Swiss Business Hub Japan

The Pharmaceutical Affairs Law which governs the approval and licensing for importation of medical devices into Japan has been revised.

Medical Industries Corp. gives support in approval and licensing procedures and contracts, process software validation, risk managementIt can often be difficult, particularly for smaller companies, to assess and manage the risks associated with developing export businesses. As well as those risks associated with the competition that could threaten the export programme’s financial success, the prospective target market may also present product-related risks. Such product-related risks are the result of product requirements and safety regulations which must be satisfied before a product can be circulated within the target market.

There is also the possibility of defective products inviting claims for substantial liability damages, particularly where the product has caused personal injury. Such cases might lead to expensive product recall operations. Within this context, it is important to realise that in the European Union (and in Switzerland), other types of error, such as a misleading instruction manual, can provoke the same consequences as a defective product.

With this in mind, it pays dividends to consider risk aspects at an early stage, even during product development. In collaboration with the Swiss-based Zurich Financial Services insurance company, Osec has developed a joint platform covering the most important aspects of risk management. and audit for foreign manufacturers. Those are required under the revision of the Pharmaceutical Affairs Law.

Source:
Medical Industries Corporation, MIC

Contact: Swiss Business Hub Japan

JPMA (Japan Pharmaceuticals Manufacturers in Japan) is a voluntary organization of research-based pharmaceutical manufacturers in Japan.
The following document describes the pharmaceutical administration and regulations in Japan. 
 
Contact: Swiss Business Hub Japan

Source: Japan Pharmaceutical Manufacturers Association JPMA