医療機器 許可

行政書士 無料相談


トップページへ

医療機器許可申請サポート


医療機器とは


医療機器を製造(輸入)販売するには


製造販売業等の許可要件について


医療機器の承認・認証・届出について


薬監証明の取得について


医療機器専門用語集

サポート行政書士法人


会社案内


依頼するメリット


料金表


お問合せ

 border=
行政書士スタッフブログ


行政書士 スタッフブログ

行政書士 無料相談



新宿オフィス 新宿駅

秋葉原オフィス 秋葉原駅

名古屋オフィス 名駅

大阪オフィス 西梅田駅

プライバシーポリシー・免責


Medical Devices

We offer services in obtaining business licenses for medical devices.

●Our services

  • Obtaining license for Manufacturing (production) and distribution of medical devices
  • Obtaining license for Manufacturing (production) of medical devices
  • Obtaining approval for medical devices
  • Drawing up a instruction manual of GQP*(Good Quality Practice) and GVP(Good Vigilance Practice)
  • Providing solutions for QMS(Quality Management System)

    *GQP(Good Quality Practice) and GVP(Good Vigilance Practice) ought to be met by the measurement laid down in the Ministerial Ordinance.

■Manufacturing (production) and distribution of medical devices

Importing, leasing, conferring and distributing the medical devices. The applicant may obtain one of the following types of licenses.

  1. Type I Manufacturing (production) and distribution of medical devices (specially controlled medical devices aka. Class III, IV)E.g. contact lens, artificial bone, dialyzer
  2. Type II Manufacturing (production) and distribution of medical devices (controlled medical device aka. Class II)E.g. dental material, Electrical massage device for home use, X-ray generator
  3. Type III Manufacturing (production) and distribution of medical devices (general medical devices aka. Class I)E.g. scalpel, tweezers, Eyeglass lenses
  4. Deposit the capital into the company’s bank account.
  5. Last but not least, the registration with the Ministry of Justice. This process should take about 10-14 days.

NB. Class I holder can use Class II and Class III devices. And Class II holder can use Class III devices.

●Reasons for disqualification

  1. The applicant or the board of directors of the company has been cancelled the license in the past 3 years.
  2. The applicant or the board of directors of the company has been sentenced to imprisonment in the past 3 years.
  3. The applicant or the board of directors of the company has committed a drug offence or any offence to that effect in the past 2 years.
  4. The applicant or the board of directors of the company is mentally disturbed and is unable to run a business.

●Requirements

  • Full time marketing supervisor, quality assurance manager and safety management supervisor should be stationed. Marketing supervisor should have sufficient knowledge or experience.
  • Quality of devices should be strictly complied with GQP(Good Quality Practice)
  • safety control standards for devices after manufacture and sale should be strictly complied with the Ministerial Ordinance on GVP(Good Vigilance Practice)

■Manufacturing (production) of medical devices

Manufacturing medical devices. The medical devices manufactured could only be distributed, leased or conferred by the consignor or the consigned manufacturer(actual supplier).

Types of devices are as follows

  1. Medical devices authorised by the Minister of Health, Labour and Welfare(大臣権限医療機器)
  2. Sterilization
  3. General medical devices
  4. medical devices which does packaging, indicating and storing

●Requirements

  • Equipment and Facilities should comply with the standard laid down in the Ministerial Ordinance on pharmaceutical facilities.
  • Chief technician should be stationed. S/he should have sufficient knowledge or experience.

●Reasons for disqualification

  1. The applicant or the board of directors of the company has been cancelled the license in the past 3 years.
  2. The applicant or the board of directors of the company has been sentenced to imprisonment in the past 3 years.
  3. The applicant or the board of directors of the company has committed a drug offence or any offence to that effect in the past 2 years.
  4. The applicant or the board of directors of the company is mentally disturbed and is unable to run a business.

■Distributing and leasing medical devices

If you wish to distribute or lease medical devices, you need to obtain a license for distribution and lease for each office.

General medical device

No authorization required

Controlled medical device

Report

Specially controlled medical device

license

Specified controlled medical device(特定保守管理医療機器)

license

●Requirements

  • The facilities and equipments of an office should comply with the Ministerial Ordinance on pharmaceutical facilities.
  • Qualified supervisor should be stationed at each office.

Yakkan certificate

Yakkan certificate is required be shown at a custom when the medical device is not yet reported or authorised by Japanese government. You need to prepare necessary documents and apply for a certificate to regional bureau of the Ministry of Health, Labour and Health. Our experienced staff will undertake application process for you.

■Yakkan Shomei certificate is needed where…

  1. Medical doctors and dentists import medical devices more than a specified number.
  2. A company imports medical devices for the purpose of special research and development or for sample use.
  3. An education institute or public organization imports medical devices in order to display at an exhibition.
  4. An individual imports medical devices in order to display at an exhibition.
医療機器許可
Copyright (C) Support Solicitor Office. All Rights Reserved.

家族滞在ビザ就労ビザ帰化宅建免許ファンド組成旅行業登録運送業許可倉庫業登録QMS省令本店移転日本支店設立永住ビザ大阪化粧品許可申請建設業許可申請適格機関等投資家特例業務NPO法人設立医療法人設立宗教法人設立