SUNGO Global Regulatory Services
SUNGO Global Regulatory Services is a trusted compliance service provider for the healthcare industry, specializing in international medical device registration and consulting.
Established in 2006, SUNGO Global Regulatory Services (SUNGO) is dedicated to facilitating the global circulation of health products and aims to be the most trusted compliance service agency. With its group headquarters in Shanghai, China, SUNGO has established international branches in Rotterdam, Netherlands; Düsseldorf, Germany; Zug, Switzerland; London, UK; Sydney, Australia; and Kentucky, USA. These branches offer local representation and device registration services to global manufacturers. Domestically, SUNGO has three subsidiaries in Wuhan, Guangzhou, and Hefei, providing localized technical support. The group boasts two medical device laboratories with China's national CMA qualification, also accredited by CNAS and IAS, and an ANAB-accredited medical device quality system certification body. This robust infrastructure enables SUNGO to deliver comprehensive compliance solutions. SUNGO's core services encompass international medical device registration (EU, UK, US, Australia, Canada, Saudi Arabia, Brazil, China), consulting (MDR, IVDR, 510k, NMPA GMP, QSMR820), and testing (sterilization validation, active device validation, rehabilitation device testing). They have served over 6,000 clients across more than 30 countries, including a significant portion of China's top 100 medical device companies and several global top 100 enterprises. SUNGO holds leading market shares in China for EU, US, UK, and Swiss registrations.
About
**Who they are**
SUNGO Global Regulatory Services, established in 2006, is a compliance service provider dedicated to facilitating the global circulation of health products. The group headquarters is located in Shanghai, with international branches in Rotterdam, Düsseldorf, Zug, London, Sydney, and Kentucky, and domestic subsidiaries in Wuhan, Guangzhou, and Hefei.
**Expertise & scope**
- International medical device registration (EU, UK, Switzerland, USA, Australia, Canada, Saudi Arabia, Brazil, China)
- Consulting services (MDR, IVDR, 510k, NMPA GMP, QSMR820)
- Testing and inspection (sterilized device validation and testing, active device validation and testing, rehabilitation device specific testing)
- Local representation and device registration services
- Post-market surveillance
**Reputation / proof points**
- Over 6,000 clients globally across more than 30 countries and regions.
- Over 30% of China's top 100 medical device companies are clients.
- Includes services for global top 100 medical device companies.
- Holds two medical device laboratories with China National CMA qualification, also accredited by CNAS and IAS.
- Possesses an ANAB-accredited medical device quality system certification body.
- Market share in China for core business areas is industry-leading.
- EU registration market share approximately 30%.
- US registration market share approximately 15%.
- UK registration market share approximately 35%.
- Switzerland registration market share approximately 20%.
SUNGO Global Regulatory Services, established in 2006, is a compliance service provider dedicated to facilitating the global circulation of health products. The group headquarters is located in Shanghai, with international branches in Rotterdam, Düsseldorf, Zug, London, Sydney, and Kentucky, and domestic subsidiaries in Wuhan, Guangzhou, and Hefei.
**Expertise & scope**
- International medical device registration (EU, UK, Switzerland, USA, Australia, Canada, Saudi Arabia, Brazil, China)
- Consulting services (MDR, IVDR, 510k, NMPA GMP, QSMR820)
- Testing and inspection (sterilized device validation and testing, active device validation and testing, rehabilitation device specific testing)
- Local representation and device registration services
- Post-market surveillance
**Reputation / proof points**
- Over 6,000 clients globally across more than 30 countries and regions.
- Over 30% of China's top 100 medical device companies are clients.
- Includes services for global top 100 medical device companies.
- Holds two medical device laboratories with China National CMA qualification, also accredited by CNAS and IAS.
- Possesses an ANAB-accredited medical device quality system certification body.
- Market share in China for core business areas is industry-leading.
- EU registration market share approximately 30%.
- US registration market share approximately 15%.
- UK registration market share approximately 35%.
- Switzerland registration market share approximately 20%.
Additional information
SUNGO Global Regulatory Services emphasizes maintaining smooth communication with clients and regulatory authorities, providing timely responses to inquiries, and offering support to authorities when necessary. They are responsible for securely storing client technical documentation according to regulatory requirements and acting as the manufacturer's European representative for device registration. The SUNGO Europe B.V. service team is proficient in Dutch, English, and Chinese, possessing specialized backgrounds in the medical device industry and European regulatory policies. For existing clients, inquiries can be directed to Ec.rep@sungoglobal.com, while potential clients should use info@sungoglobal.com. In-person meetings in the Netherlands require one week's advance notice via phone.
Key Highlights
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Founded in 2006, with over 15 years of experience in global health product circulation.
Source
“SUNGO（沙格）品牌创建于2006年。以助力大健康产品全球流通为使命，我们致力于成为最受用户信赖的合规服务机构。”
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Operates international branches in the Netherlands, Germany, Switzerland, UK, Australia, and the USA.
Source
“国际上在荷兰鹿特丹，德国杜塞尔多夫，瑞士楚格州，英国伦敦，澳大利亚悉尼以及美国肯塔基州设有6家分支机构。”
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Possesses two medical device laboratories accredited by China National CMA, CNAS, and IAS.
Source
“集团拥有两家获得中国国家级CMA资质的医疗器械实验室，这些实验室同时获得CNAS和IAS认可资质。”
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Serves over 6,000 clients globally, including a significant portion of China's top medical device companies.
Source
“集团客户总数超过6000家。客户覆盖全球六大洲，遍布30多个国家和地区。中国医疗器械100强企业超过30%选择SUNGO”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers seeking international regulatory compliance.
- Companies requiring assistance with device registration and consulting across multiple global markets.
How engagement typically works
- Direct service provision for registration and consulting.
- Acting as local representative and post-market support.
Typical deliverables
- International device registration approvals.
- Regulatory consulting reports and guidance.
- Testing and validation reports.
- Quality system certification.
Good to know
- Best when requiring comprehensive support for global market access, particularly in Europe and North America.
HQ:
Shanghai, CN
Languages:
English, Chinese
Timezones:
Australia/Sydney
Claim status:
Listed
Services & Capabilities
AU TGA Sponsor Services
Jurisdictions:
AU
Countries:
AU
Industries:
Medical devices, Dental
Portfolio:
100+
Onboarding time:
3–21 days
Pricing model:
Per project
Starting from:
AUD 5,000
Included services:
Change notification and variation assessment, Annual ARTG charge reminders and continuity planning, ARTG inclusion application preparation and submission, eBusiness Services account setup support
Supports Artg:
Yes
Australian Entity State:
Sydney (implied by branch location)
Recall Vigilance Support:
Yes
Evidence Review:
Yes
Additional tga_sponsor_au Details
Device Classes Supported
Class I, IIa, IIb, III (implied by scope of services)
Supports Artg
Yes
Recall Vigilance Support
Yes
Onboarding Steps
Inquiries for potential clients should be directed to a specific email address. Existing clients can use a separate email. Face-to-face meetings require advance booking.
Australian Entity State
Sydney (implied by branch location)
