Bilingual and Cross-Cultural Professional Company

We Provide Turn-Key Solutions for MedTech Clients Enter into China Market and Keep Life-Cycle China Regulatory Compliance

100+

Products Registered

130+

Happy Clients

2

Regional Offices

45+

RA/QA Consultants and In-net experts

Our professional services are focused on the end-to-end Regulatory affairs Issues. Our bilingual and cross-cultural experts help you with the regulation’s interpretation in a manner of US FDA terms as well as introduction of the background behind the scenes. We provide you hands-on regulatory compliance solutions to release you from the frustration.

Medical Device Registration in China

Our service covers the overall strategy, specific concerns, type testing, to submission dossier preparation.

GMP Compliance

Our service covers the life-cycle compliance from pre-approval to post-market. We also provide tailored China GMP training and QMS GAP analysis.

Clinical Evaluation

Our Service covers the clinical pathway strategy report, clinical evaluation report (CER) , and clinical trial coordination.

Post Market Surveillance

Medical device post market surveillance includes annual report (AR), product recall, adverse events reporting (AE) and periodical re-evaluation of the risks (PRER).

Added-Value Services

We dedicated to providing you added-value services on-line, or in person.
Webinars
Newsletters
Blogs
On-line Meetings

Served Products

The medical device industry is a multidisciplinary field. We are proud of our involvement in the product area thanks to the efforts of our team of experts and external in-net consultants. The service includes product registration, Clinical evaluation, Whole Life-Cycle compliance, GMP Training, Supplier Audit, etc.

Implantable Sterile Products

Coronary drug-eluting stent Aortic valve, prosthesis, percutaneously deliver System

Energy-based Aesthetic Devices

Laser-based Devices Radiofrequency (RF)-based Devices Light-based Devices Ultrasound Devices

Respiratory Devices

Nebulizer Respiratory humidifier

Assisted Reproductive Device

Oocyte Collection Needle Intracytoplasmic Sperm Device

IVD

Immunoassay Reagents and Kits

Orthopedic Diagnostics Device

Endoscopic Release System Arthroscopy System

How It Works

Hands-on service is our promise to the clients. You won’t feel overwhelmed by not understanding Chinese culture and customs. It’s on us.

Once we receive inquiries from our clients, we will offer 15 min free consultation to understand clients’ demand. We will not start until you think our services match your needs. After signing the agreement, we will communicate with you to build up an overall plan, and set up the milestones. Report will be sent to you by milestone or per your request.

Confidential Agreement

We respect our clients' intellectual property rights and trade secrets. We will sign a confidentiality agreement before we officially cooperate.

Client Side

Provide documents and samples according to our list and the confirmed timeline. periodically meet with us to align our understanding Review the documents prepared by us and confirm its accuracy.

GVM Side

Answer your questions or concerns. Interpret relevant regulatory provisions and context. Identify relevant product standards and guidance documents. Coordinate the testing, clinical trial. Finish the report or submission dossier according to project timeline. Communicate with reviewer, test institute and NMPA officials. Other tasks defined by the agreement.

Office Locations

Our BD and PM teams are based in US to serve our MedTech clients in a timely manner. Our RA/QA professional team is based in China to leverage the local resources and network, and keep great comminication with regulatory agency, both NMPA and local branches

Great Philadelphia, US

101 Lindenwood Dr. Ste 225, Malvern, PA 19355

Guangzhou, China

1701 Kingold Century Centre, No.62, Jinsui Road, Tianhe District, Guangzhou, P.R. China 510623