Venture Zebra Group

Regulatory Consulting Services for the Import, Export and Distribution of Medical Devices

Many countries implement strict controls on importing and exporting medical devices to protect public health and safety. For US-based companies that import such commodities, the FDA requires them to register as initial distributors. For American manufacturers that intend to export their products, they are generally required by foreign governments to present export certificates that prove that their medical devices pass US standards. For international establishments planning to sell their products in the US, they need to register with the FDA as foreign exporters or manufacturers. They must also appoint a competent American resident to become their US agent. Marketing will inevitably be delayed if these complex processes are not properly accomplished.

Companies wishing to stay ahead in such a competitive industry and avoid interruptions of their international operations must avail of the services of an exceptional team of regulatory consultants. Doing so will allow them to expedite the registration process, prevent detainment of their products by local customs authorities and maximize their profits. Whatever concerns you have with regards to importing and exporting medical devices, our regulatory experts at VZG have solutions for all of them.

VZG’s consultancy package for the importation, exportation and distribution of medical devices includes the following services:

  • Establishment registration
  • Medical device reporting
  • Reports of corrections and removals
  • Medical device tracking
  • Radiation safety product report and Form FDA 2877 for radiation-emitting devices
  • QS Part 820
  • Certificate to Foreign Government (CFG)
  • Certificate of Exportability Under Section 801(e)(1) of the Federal Food, Drug and Cosmetic Act (FD&C Act)
  • Certificate of Exportability Under the FD&C Act’s Section 802
  • Non-Clinical Research Use Only (NCR)
  • Export Permit Letters
  • Establishment registration
  • Medical device listing
  • Quality System
  • Premarket notification [510(k)] or premarket approval
  • Labeling
  • Medical device reporting
  • FD&C Subchapter C requirements and radiation safety product report for radiation-emitting electronic equipment
  • We act as your US agent. Please visit our US Agent Services page here for further information.
  • Notice of sampling
  • Refusal of admission
  • Application for authorization to relabel and recondition
  • FDA inspections
  • Management of other complaints

The distribution of medical devices in China is also highly controlled, and the approval process is just as rigorous. For establishments seeking to market their medical devices in China, we offer the following services:

  • Compliance consultancy
  • Regulatory approval consultancy
  • Training services
  • Clinical trials
  • VZG shall act as your product sponsor
  • Prosthesis list
  • Pre-audit preparation and review
  • Assistance and representation during quality audits

Why Choose VZG?

Proven Track Record

VZG consultants have helped numerous clients in getting their products in international markets smoothly and efficiently.

Timely Interventions

Our clients can attest to our competent and quick handling of issues that are unique to importation and exportation.

Client Advocacy and High Level of Integrity

VZG’s team of professionals guarantees that the FDA and local customs officials will treat our clients fairly and expeditiously.

VZG’s team of professionals guarantees that the FDA and local customs officials will treat our clients fairly and expeditiously.