大分類

医療機器

中分類

海外申請

小分類

眼科

詳細

クラス3の埋め込み機器に関して、東南アジア諸国への製品登録や変更/登録維持を行っております。

履歴:

- IOL 製品の海外への製品登録や変更申請 (Singapore, Malaysia, Indonesia, Thailand, Vietnam, Saudi Arabia, and Pakistan)

- FDAへのIDE申請 (pre-sub meeting 含む)

 

- 申請資料の作成および、その後の各国のARを通しての、規制当局との議論・交渉

こちらのExpertとのミーティングを行う場合は、禁止行為、個人情報の扱い等を利用規約、プライバシーポリシーでご理解の上、これらに同意の上でお申し込みください。お申し込み後、ミーティングリクエストは簡単な操作でできます。ミーティングが成立しますと、あなたが新規登録時に入力されたメールアドレスにWEB会議案内が届きます。

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Major classification

Medical Device

Middle classification

Product Registration (Overseas)

Subcategory

Ophthalmology

detail

I am in charge of product registrations and their maintenance (e.g. change notification) with regard to a class III product (implant) for ASEAN countries.

Experiences:

- Regulatory registration and Change notification of IOL products to overseas (Singapore, Malaysia, Indonesia, Thailand, Vietnam, Saudi Arabia, and Pakistan)

- IDE submission for FDA including pre-submission meeting

 

- Documentation of Dossiers and negotiation/discussion with regulatory agencies through authorized representatives in each country.

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