Medical device CRO, GMP manufacturer, & distributor in Kunshan, Shanghai, Boston, and New York City
Comprehensive services for your medical device at every stage.
We concentrate on the unique needs of medical device and diagnostic companies. Since 2012, we’ve utilized our global reach and clinical expertise to guide device and diagnostic companies through regulatory planning, clinical trials, CFDA approval, GMP manufacturing to post-marketing and commercial strategies.

Regulatory Approval

The regulatory roadmap in China differs for Class I, II and III medical devices. Longtech’s multi-disciplinary clinical, legal, and technical teams expertly guides device companies through China’s regulatory processes. Our mission is to help you obtain a Medical Device Registration Certificate from the CFDA so that you can sell your medical device in China and abroad. We guide you through the following:

  • Determining your best route to CFDA approval
  • Developing your Product Registration Standard
  • Handling your Medical Device Type Classification
  • Preparing for Technical and Administrative Review
  • Passing inspections and maintaining compliance at all stages

Clinical Trials

The CFDA requires manufacturers of higher-risk class II and III devices to conduct clinical trials within China before selling in the marketplace. Setting up clinical trials, recruitment, facilities, study designs and personnel issues while managing compliance with CFDA regulations requires considerable time, experience, and resources.

As a specialty China CRO with national reputation, we ensure that your clinical trial requirements are met – all with keen attention to quality management and Good Clinical Practices. Let us guide you through registrations and the Chinese clinical study process:

  • Designing your study
  • Determining clinical protocol
    • literature review
    • clinical requirements analysis
    • sample size estimates
    • develop protocol design
    • CFDA-approved site selection
    • feasibility analysis
  • Processing for Institutional Review Board (IRB) approval
  • Selecting and recruiting subjects
  • Handling data management and audits
  • Performing statistical analyses
  • Hosting panel reviews and inspections
  • Submitting your final clinical study reports
  • Reusing your clinical study results abroad for FDA approval or CE mark
  • Analyzing post-market surveillance data

Manufacturing Facilities

As part of Longtech’s comprehensive services we provide turn-key GMP compliant manufacturing facilities. In combination with our registration and clinical trial services, Longtech's manufacturer facilities will let you streamline your devices development all the way to its final commercialization. We can help you with:

  • Turn-key Factories and Laboratories
  • Custom Production Systems Design
  • Quality Control and Risk Management
  • Onsite EtO Sterilization
  • Packaging and Labeling
  • Product Warehousing and Distribution
  • Maintaining and Documenting GMP Compliance

Sales & Marketing

With approximately 1.3 billion people, 310,000 hospitals, and over 160,000 medical distributors, navigating the Chinese market is complex. We streamline this time- and effort-consuming process with our in-house legal and sales headquarters and broad distribution network. We provide:

  • Class II and III medical devices sales qualification
  • Domestic legal agents (LA) and after sales agents (ASA), both required to sell devices in China. The LA will interact with CFDA on your behalf during device registration, serve as the primary point of contact with Chinese authorities, and assist in registration renewals. The ASA will handle any incident reporting to Chinese authorities.
  • Broad distribution network to over 30 provinces and key cities
  • Access to key hospitals in Hebei, Shanxi, Jiangxi, Hunan, Shanghai and more
  • Experienced sales team led by a managing team with 30+ years in the medical devices industry

Office Space

Longtech offers private offices, shared workspace, community, and services for entrepreneurs and their companies.

  • 24/7 access to dedicated office space
  • Workspaces and conference rooms for 1:1 conversations, small group sessions, or larger board meetings
  • Fully connected conference rooms with TVs, wireless screen projectors, speakerphones, whiteboards, and facilities equipped for international video conferences
  • On-site mail and package handling services and notary services

Support Network

Longtech also supports our companies by providing them access to a group of strategic advisors, mentors, corporate partners, and growth partners in China.

  • Partners: service providers in banking, legal, HR, and more
  • Mentorship: hiring, company culture, scaling, sustainable sales, finances, fundraising and more
  • Fundraising: introductions to accelerators, incubators, and investors
Boston and New York
Longtech Medical has international representatives in New York and Boston, ready to meet with you and talk in detail about your needs.
Get in Touch