A person/company intending to manufacture medical devices in foreign countries that are to be exported to Japan shall be called foreign manufacturer, and is required to be accredited under Article 13-3 of PAL in the same way the Japanese manufacturer is licensed.

A foreign manufacturer (a person/a company) intending to manufacture medical devices in foreign countries and export them to Japan is required to be accredited by the Minister of Labour, and Welfare as an "Accredited Foreign Manufacturer," specified in Article 13-3 of PAL (Pharmaceutical Affairs Law), in the same way the Japanese manufacturer is licensed.

The attached summary technical documentation shall be prepared by an applicant on an overview of the medical device for which a marketing approval application is submitted, based on the technical documents attached to the application form. It must be summarized accurately and concisely, including the applicant's evaluation of clinical usefulness, with regard to flow of development such as the applicant's views and basis for judgment during the development process, key points on quality, efficacy, and safety.

「 attached summary technical documentation 」と「 technical documents attached to the application form 」の二種類が言及されており、日本の申請資料の構成をあまり理解していない読み手には紛らわしいと考えられるため、「 STED 」という略称を用いることですっきりさせることができる。また、文章を区切ることによって、より読みやすくなる。

With regard to manufacturing and marketing approval for a medical device, when an application was submitted by an applicant who intends to manufacture and market a medical device or who intends to have an appointed marketing authorization holder market a medical device according to the provisions of Article 14 and Article 19-2 of the Law, the Minister of Health, Labour and Welfare shall grant his approval for its marketing upon the required evaluation of the medical device in terms of intended use, indications, structure, principle, raw materials, components, product specifications, operation methods, malfunctions, etc. for each every item, excluding general medical devices as stipulated in Article 2, Paragraph 7 of the Law or medical devices with specified standards designated by the Minister of Health, Labour and Welfare based on the provisions of Article 23-2, Paragraph 1 of the Law. In the case of application for marketing approval, technical documents possible to ensure the ethics, scientific soundness, and reliability of the medical device based on the current academic standards of medicine, pharmacology, or engineering at that point in time to fully verify the quality, efficacy, and safety of the medical device for which the application is submitted must be provided.

和文では「製造販売」であるが、「 marketing 」と英訳されることが多い。法令で定義が示されている専門用語に対して通常用いられている訳語を一貫して用いることにより、読み手の理解を助ける。異なる訳語を用いてしまうと、同じものを指しているかどうか読み手にとってわかりにくくなってしまう。

原文自体が非常に長く、慣れない読み手にとっては原文を読んでも理解が困難である。そのまま英訳してしまうと、背景となる知識があまりない読み手にとってはさらに理解が困難となる。そのため、内容を十分理解した上での翻訳が求められる。

また、このような文章では特に主語と述語が離れがちなため、注意が必要である。

When an application for marketing approval for a medical device is submitted by an applicant who intends to market a medical device or who intends to have an appointed marketing authorization holder market a medical device according to the provisions of Article 14 and Article 19-2 of the Law, the Minister of Health, Labour and Welfare shall, for every item, grant his approval for its marketing upon the required evaluation of the medical device in terms of intended use, indications, structure, principle, raw materials, components, product specifications, operation methods, usage methods, malfunctions, etc., excluding general medical devices as stipulated in Article 2, Paragraph 7 of the Law or medical devices with specified standards designated by the Minister of Health, Labour and Welfare based on the provisions of Article 23-2, Paragraph 1 of the Law. The application for marketing approval must be accompanied by technical documents possible to ensure the ethics, scientific soundness, and reliability of the medical device based on the current academic standards of medicine, pharmacology, or engineering at that point in time to fully verify the quality, efficacy, and safety of the medical device for which the application is submitted.

"New medical device" refers to a medical device that is clearly different from medical devices that are already approved or certified for marketing in terms of structure, principle, usage method, indications, performance, etc.

この文章において一番重要な要素である「構造、原理、使用方法、効能又は効果、性能等」が文末に来ているが、文頭に近い位置にある方が印象付けやすいと考えられる。

“New medical device” refers to a medical device whose structure, principle, usage method, indications, performance, etc. is clearly different from those of medical devices already approved or certified for marketing.

As for data of clinical studies conducted in foreign countries (hereinafter referred to as "foreign clinical study data"), in case it meets all the requirements stipulated in Attached table, it shall be accepted as material reviewed for application for approval of manufacture (or import) of medical devices.
In addition, as for domestic clinical data that have been required as supplemental data for medical devices that are to be implanted in body and could affect biocompatibility, it does not need to be submitted in principal, except for those medical devices with new structure and used for new treatment etc. that is not yet established in Japan.

「 生体に埋植して使用されるもので生体適合性に影響を及ぼすような医療用具」に対する訳語が長く、「 implantable medical devices 」と訳すと理解しやすい文章になる。

Data of clinical studies conducted in foreign countries (hereinafter referred to as “foreign clinical study data”), in case it meets all the requirements stipulated in Attached table, shall be accepted as application material to be reviewed for approval of manufacture (or import) of medical devices.
In addition, domestic clinical study data that have been required as supplemental data for implantable medical devices that could affect biocompatibility are not, in principle, needed to be submitted, except for those medical devices with new structure and used for new treatment etc. that is not yet established in Japan.