Medical / Healthcare /Cosmetic Industry
Client Testimonials (Available only in Japanese)
寄り添う姿勢と柔軟な対応、なにより専門領域に対するビジネス面での深い理解にいつも助けられています
株式会社CureApp 佐竹 晃太様
──御社の事業についてと、最近のトピックを教えてください当社は、治療用アプリと呼ばれる、医療の現場において、新しい治療方法の研究開発又は事業化を進めている医療系スタートアップです。数年前から医療の現場…
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Practice Areas
Research on regulations and the establishment of a business model
There are many relevant regulations and guidelines to medical and healthcare, and they are complex as they relate to human body and life.
Therefore, before conducting a new business, such as launching new services or products, companies are required to research on the relevant regulations and verify whether they can be legally implemented.
In addition to research on regulations to define problematic issues, we work closely with our clients to assist in developing business schemes (we are also able to provide services to some overseas regions).
Advice on Medical Devices Programs
Recently, medical devices program has been drawing attention along with the development and release of therapeutic applications (SaMDs) on a global scale.
GVA LPC provides practical advice on matters such as determining the applicability of programs to medical devices, and regulations, industry situations, and applications for approval.
Advice on advertising regulations
In recent years, the Pharmaceutical and Medical Device Act has been amended to introduce an administrative monetary system, and advertising regulations on medical have become stricter.
In addition, advertisements are subjected to the Medical Care Act and the Medical Device Act (and its guidelines), self-regulations which were set forth by industry groups (promotion codes, etc.), and they cover a broad range of complex topics.
GVA LPC offers a service package, the “Advertising Regulations Manual Package”, which enables clients to check advertising regulations by themselves and is customized to the client’s needs.
In addition, GVA LPC has been providing a variety of support such as legal checks on advertisements and proposals for amendments, advice on how to deal with administrative guidance in the field of medical devices, medical-, cosmetics-, and beauty appliance-related services.
Based on our experience, we provide practical services to clients involving with medical-related advertisement.
Features
In the field of medicine, beauty, and healthcare, strict regulations are imposed to ensure the safety of people’s lives and bodies.
As a result, there is a variety of relevant laws and regulations. To conduct business in a manner that does not conflict with legal restrictions set by law, it is essential to seek the advice from experts in the relevant field.
In addition to our legal knowledge of medical laws, our attorneys who are familiar with the business and industry, provide services by thinking ahead of not only legal matters but also on businesses.
Achievements
Case Examples
- Legal advice on and business structuring of a telemedicine service
- Legal advice and business structuring for the sales of emergency contraceptives and propecia
- Legal advice and business structuring for the development, the manufacturing, and the sale of new orthodontic appliances
- Product Building, including research on the applicability of medical devices
- Building services, including research on the applicability to medical practices
- Research and construction of models for regulations on monetization (e.g., the Payment Services Act and Medical Care Regulations)
- Advice and support for medical device programs
- Legal advice on advertising regulations for LP and influencer marketing
- Support for negotiations with administrative agencies regarding matters indicated by administrative agencies on words used in advertisements
- Preparation of Terms of Use (Terms of Service) and a Privacy Policy regarding applications to be used in medical-related services (SaaS, etc.)
- Preparation of informed consent forms on gene-related businesses
- Joint Research and Development Agreement in an industry-academia collaboration
- Joint Research and Development Agreement with pharmaceutical companies (Suppliers in Japan and Overseas)
- Patent licence agreement in pharmaceutical and genetic fields (Japan and Cross-border)
- Partnership Agreements with hospitals, pharmacies, doctors, dentists, dental technicians, and other medical professionals
- Partnership Agreements with health insurance societies
- Regulatory advice on monetary such as discount coupons for healthcare services (e.g., Collection Agencies, Fund Transfer Service Providers)
- Advice on Rules for Health Insurance-covered Medical Facilities and Medical Practitioners and Health Care Fees
- Advice on cross-border transactions such as cross-border EC and sales of cosmetics
- Advice on labor issues for employees
- Consultation on funding (finance: equity, debt)
- Support for the preparation of various regulations on the day of the IPO
- Support for M&A, from legal due diligence to the conclusion of the definitive contract
Various support packages
Advertising Regulation Support Package
- Provision of instruction manuals and checklists describing the advertising regulations for each industry, mainly on medical care
- Providing a support system by attorneys who are familiar with the industry
Providing a support system by attorneys who are familiar with the industry
- Life Science Innovation Network Japan (LINK-J)
- Japanese government-led Regional Revitalization Plan
- Japan Venture Capital Association
- Japanese Telemedicine and Telecare Association
- Support Group of Healthcare Innovation Hub
Seminars
＜Latest Seminars＞
- 株式会社セミナーインフォ主催「「遺伝子検査のビジネス活用とその留意点」」
- GVA主催オンラインセミナー「医療法等改正の概要」全３回
第１回 「医師の働き方改革」
第２回 「各医療関係職種の専門性の活用」
第３回 「地域の実情に応じた医療提供体制の確保」 - 一般社団法人日本医療ベンチャー協会主催 設立4周年記念オンラインシンポジウム
「大企業からみた医療・ヘルスケアベンチャーとのエコシステムビルディング」 - GVA主催オンラインセミナー
「ヘルステックビジネスを推進する産学連携・共同研究契約における留意点」 - GVA主催オンラインセミナー
「ヘルステックビジネスと医療情報システムにかかわる情報管理ガイドライン」 - GVA主催オンラインセミナー「オンライン医療に関わる法律の現在地」
- GVA主催オンラインセミナー「ヘルステックビジネス推進に必要な法務基礎知識及び薬機法改正の概要」
その他多数
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