Qualifications & Programs · Healthcare licenses

Class II medical device business filing

Eligibility pre-review, document preparation and application progress tracking

Estimated timeline
2-10 working dayscounted from receipt of complete documents
Key deliverable
Filing receipt or filing result
Packages
Standard processing

What you provide

  • Original business license / official seal
  • Copy of the academic qualification or professional title certificate of the legal representative / enterprise person in charge / quality person in charge + ID
  • Location map and floor plan of the business premises / warehouse address
  • Area requirement of 30 square meters or more (property documents: property ownership certificate (non-residential) / or site use certificate / or housing lease registration / + lease contract)

What you receive

  • Filing receipt or filing result
  • Project delivery checklist

Service Content

Providing preliminary assessment of application conditions, documentation checklist preparation, document pre-review, application assistance and progress tracking for [Class II Medical Device Business Filing].

Prices follow the service listing. Where government approval or official review is involved, the outcome rests with the authorities and cannot be guaranteed.

Class II medical device business filing · Zhongwai Enterprise Service Center