欧州法定代理人サービス

EU法定代理人 | 英国法定代理人 |スイス法定代理人

Arazy Groupはこれまで24年以上に渡り、数多くの企業様のEU認定代理⼈としての役⽬を果たすとともに、英国(MHRA)、ドイツ(BfArM)、アイルランド(HPRA)の各国当局との重要な関係も構築してきておりますので、欧州各国での薬事申請業務を円滑に進めることができております。私どもは貴社のMDR、IVDRならびにContingency MedDoに対するコンプライアンスの確実なサポートを行い、引き続き欧州各国における製品の登録と継続販売が行えるようにいたします。

経験年数

AArazy Groupは医療機器および体外診断機器における経験豊富なグローバル薬事コンサルティング会社です。1996年以来、弊社の英国オフィスは英国当局(MHRA)と密接な関係を築いており、現在、英国における法定代理人としての機能も果たしております。また、弊社のアイルランドおよびドイツのオフィスは医療機器および体外診断製品メーカーの皆様のEU法定代理人サービスを提供しております。.

ワールドワイドのサポート

Arazy Groupは世界140ヶ国において業務を行っております。リコールや有害事象報告などが生じた場合、必要に応じて、現地でのサポートを現地語および現地時間で提供することが可能です。 

薬事のオンラインソルーション

Arazy Group独自のオンライン薬事管理プラットフォーム、LICENSALEは貴社の薬事登録プロセスを簡素化し時間を短縮します。このシステムは貴社の大切なコンプライアンス情報を安全に保管するとともに当局や認証機関および代理店と情報の共有も行うことができます。LICENSALEを通じて、私どもは薬事承認取得プロセス全体を通して貴社のサポートを行い、申請書類のレビュー、要求事項に適合するためのアドバイスを行います。

ワンストップの法定代理人サービス

Arazy GroupはEU法定代理人、英国法定代理人、およびスイス法定代理人サービスを提供しております。また、当社独自の薬事管理システムを通じてサービスの提供を行います。

面談は日本語および英語のいずれでも対応しております。

 EU AR

(EU法定代理人)

Arazy Groupはこれまで24年以上に渡り、数千社にのぼるクライアント企業様のEU法定代理人としての機能を果たしてきた経験がございます。また、弊社は各医療機器に特定したテクニカルファイルのチェックリストやギャップ分析レポートなどのサービスも行っております。

 UK REP

(英国法定代理人)

英国のEU離脱およびEUの新たなMDRおよびIVDRの施行に伴い、UK(英国)において適任の法定代理⼈(Responsible Person)指定することが重要となっております。Arazy Groupは英国当局(MHRA)と長年に渡って良好な関係を築いていますので、英国における迅速な移行とコンプライアンスの継続を確実にサポートすることが可能です。

SWISS REP

(スイス法定代理人)

スイスは2021526日付でEUとの協定が終了したことにより、医療機器機器メーカーはスイスにて医療機器を販売するうえで移行措置に基づいて、スイスの法定代理人を任命する必要が生じました。すぐにその準備を始めましょう!

法定代理人に関する追加情報(英語)*

EU Authorized Representative
An EU Authorized Representative in any natural or legal person responsible for acting on the manufacturer’s behalf to assist with regulatory tasks under the manufacturer’s obligation in the EU market.

The EU Authorized Representative has the following obligations:

  • Verifying that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
  • Keep copies available of all documents and make them accessible to authorities on request (this includes technical documentation, declarations of conformity, and certificates, including their amendments and supplements)
  • Verify that the manufacturer has registered the requested information in EUDAMED
  • Cooperate with authorities on preventive and corrective actions, and inform the manufacturer immediately about complaints and authorities’ requests for samples of devices.
  • Liable for defective devices together with the manufacturer, if the manufacturer has not complied with its obligations under the Regulations and is not located in the EU.

More information here.

UK Responsible Person
The UK Responsible Person will act on behalf of the manufacturer to assist with regulatory tasks under the manufacturer’s obligation in the United Kingdom. Manufacturers based outside the UK will need to designate a UK Responsible Person that is established in the UK.

The UK Responsible Person has the following obligations:

  • Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
  • Keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA.
  • In response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device.
  • Forward to the manufacturer any request by the MHRA for samples, or access to a device, and ensure that the MHRA receives the samples or has been given access to the device.
  • Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
  • Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
  • Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the MHRA and, if applicable, the relevant notified body of that termination.

More information here.

Swiss Representative

The Federal Council, the Federal Office of Public Health (FOPH) will put into force the amended Medical Devices ordinance (“Contingency MedDO”) if the Mutual Recognition Agreement between Switzerland and the European Union (EU) is not updated by this May 26, 2021 to include the Medical Device Regulation (MDR). This would result in Switzerland as a third country requiring changes and additional measures for foreign manufacturers to supply their medical and in-vitro diagnostic devices to Switzerland.

The adaptation of the Swiss medical device law is occurring in coordination with the transition periods in the EU. Manufacturers should be aware that the Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) will most likely not be updated by 26 May 2021. To prepare, manufacturers must designate an importer and a Swiss authorised representative from to supply devices to Switzerland.

The Contingency MedDO provides transitional periods for the appointment of a Swiss representative, including corresponding labelling, staggered according to risk classes:

Until 31 December 2021:

  • Class III devices
  • Class IIb implantable devices
  • All active implantable devices

Until 31 March 2022:

  • Non-implantable class IIb devices and class IIa devices

Until 31 July 2022:

  • Class I devices, systems and procedure packs

Economic operators who have already placed products on the market before 26 May 2021 must complete their registration by 26 November 2021, in accordance with the MDR and IVDR.

Learn more here.

私どもはクライアント企業様の規制へのコンプライアンスのサポートを提供いたします

弊社との面談をご希望ですか?

是非面談予約を行って始めてください! 

Arazy Groupの日本担当者と法定代理人サービスの提供オプションについて是非ご相談ください。

面談は日本語および英語のいずれでも対応しております。

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