Qualifications & Programs · Healthcare licenses
Class III Medical Device Business License
Eligibility pre-review, document preparation and application progress tracking
- Estimated timeline
- 15-20 business dayscounted from receipt of complete documents
- Key deliverable
- License or electronic license processing 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 + front and back photos or copies of ID card
- Geographic location map and floor plan of the business premises / warehouse
- Area requirement of 50 square meters or more (property documents: property ownership certificate (non-residential) / or site use certificate / or housing lease registration / + lease contract)
- Materials for entrusting a third-party medical device logistics provider: a. Copy of the third-party logistics business license + medical device business license (stamped with the official seal / the entrusted party providing storage and distribution services shall cover the business scope of the entrusting party / not required for third-party logistics within Guangzhou)
- b. Copy of the entrusted storage and distribution service agreement signed by both parties (content clearly specifying the quality responsibilities of both parties)
- c. Description of the connection between the computer system port and the third-party logistics warehouse management
- Basic introduction and functional description of the computer information management system
- Proof materials for key position personnel (ID certificate / copy of academic qualification certificate of medical-related professionals for [operating implantable and interventional devices]
- [operating contact lenses / hearing aids and other medical devices with special requirements] ID certificate / copy of academic qualification or professional title certificate of personnel with relevant professional or vocational qualifications)
What you receive
- License or electronic license processing 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 III Medical Device Business License].
Prices follow the service listing. Where government approval or official review is involved, the outcome rests with the authorities and cannot be guaranteed.