杭州甘德企业管理咨询有限公司
一、公司概况
杭州甘德企业管理咨询有限公司（简称"甘德咨询"）成立于 2010 年，是一家专业服务医疗器械产品相关事务的技术咨询服务机构，为医疗器械企业提供注册申报、许可办理、质量管理体系与海外市场准入等"一站式"注册及合规咨询服务。公司立足长三角，在杭州、苏州、上海设有办公机构。
二、服务范围
1. 注册申报
- 医疗器械产品注册、变更、延续注册（备案）咨询
- 医疗器械分类界定咨询
- 医疗器械风险管理与临床试验（豁免）咨询
2. 许可与体系
- 医疗器械经营、生产许可证（备案证）办理咨询
- 医疗器械无菌、植入等生产管理规范（GMP）实施咨询
- 年度医疗器械企业质量管理体系顾问咨询
- 医疗机构执业许可证咨询
3. 海外市场准入
- 医疗器械出口欧盟 CE 咨询
- 医疗器械出口美国 FDA 咨询
4. 专项合规
- 医疗器械出口销售证书、广告许可备案、互联网药品信息服务证和交易证咨询
三、团队构成
咨询团队由生物、化学、机械、电气、临床医学等专业背景的注册与临床专家组成。团队成员 100% 具备本科及以上学历，其中硕士及以上学历占 60%；核心成员多数具有 8 年以上医疗器械相关工作经验。来自不同专业背景的人才储备，使团队能够针对不同产品品类给出贴合实际的注册路径方案，解决医药相关技术难题，并快速响应法规变化。
四、服务成果
- 成立至今，累计服务江浙沪地区 300 余家医疗器械企业
- 协助生产企业取得 近百个各类产品注册证
- 为企业建立符合法规考核要求、并有助于提升经营效益的质量管理体系
五、合作资源
团队与国内外相关检测机构、官方机构、医疗机构建立了长期的协调与协作关系，能够保持与客户及监管部门之间的顺畅沟通，为企业提供覆盖项目全周期的注册咨询服务。
Hangzhou Gainder Enterprises Administration Consulting Co., Ltd.
About us
Founded in 2010, Hangzhou Gainder Enterprises Administration Consulting Co., Ltd. ("Gainder Consulting") is a technical consulting firm specialising in medical device registration and regulatory compliance. We offer one-stop consulting services covering product registration, licensing, quality management systems and overseas market access, serving medical device manufacturers across the Yangtze River Delta region from our offices in Hangzhou, Suzhou and Shanghai.
What we do
1. Registration and filing
- Registration, modification and renewal of registration (record filing) for medical devices
- Medical device classification and definition
- Medical device risk management and clinical trials (exemption)
2. Licensing and quality systems
- Medical device operation and production licences (record certificates)
- Implementation of Good Manufacturing Practice (GMP) for sterile and implantable medical devices
- Annual advisory on quality management systems for medical device enterprises
- Practising licences for medical facilities
3. Overseas market access
- CE marking for medical device export to the European Union
- FDA registration for medical device export to the United States
4. Specialised compliance
- Free Sales Certificates for medical devices, advertising licensing record, internet drug information service qualification and trading service qualification
Our team
Our consultants come from a range of academic backgrounds, including biology, chemistry, machinery, electrical engineering and clinical medicine. All team members hold a bachelor's degree or above, 60% hold a master's degree or above, and most have more than eight years of hands-on experience in medical device registration and clinical affairs. This breadth of expertise allows us to propose practical registration pathways for different product categories, remove technical barriers and respond quickly to regulatory change.
Track record
- More than 300 medical device enterprises served across the Yangtze River Delta since 2010
- Around 100 registration certificates obtained for manufacturers across a wide range of product types
- Quality management systems established to meet regulatory assessment requirements and improve operational performance
Our network
We maintain long-standing working relationships with testing institutions, official bodies and medical facilities in China and overseas. This enables us to keep communication smooth between our clients and regulatory authorities throughout the entire registration process.
