- Statement
EDA's device-registration guideline GL.CAMD.002 v2 (September 2025) enumerates the reference countries exhaustively (the EU/EEA states plus Australia, Canada, Iceland, Japan, New Zealand, Norway, Switzerland, the UK and the USA) and China is not among them, so an NMPA certificate confers no reference-country status. A China-made device must submit the full Appendix 1 file (declaration of conformity, CE certificate from an EU notified body, ISO 13485:2016 for the actual manufacturer, and a free-sale certificate from a reference country because the country of origin is non-reference) and is routed to the relevant specialised scientific committee before registration, which may require published clinical trials, a stamped summary of market history in reference countries, and ILAC-accredited laboratory test reports depending on device type.
- Source Jurisdiction Id
china
- Source Approval
China NMPA medical device registration certificate (Class II/III) or Class I filing record
- Target Jurisdiction Id
egypt
- China Classes In Scope
All classes (I, IIa, IIb, III; sterile and non-sterile); NMPA Class I/II/III devices are treated as 'imported from a non-reference country'
- Edge Type
No Reliance Route
- Market Access Strength
none
- Regulatory Layer
Product Marketing
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Reference-country list (Section 2 Definitions) is closed; China not listed
- Appendix 1 item 1: free sale certificate must come from a reference country when the country of origin is a non-reference country (or a USFDA CFG under item 2)
- Section 5: devices imported from non-reference countries are subject to specialised scientific committee evaluation prior to registration/re-registration
- Appendix 4 committee-specific extras for non-reference-country devices, e.g. Hematology: for all classes, published clinical trials plus a stamped summary of market history from centres in reference countries; Orthopaedics: reference-country market history, long-term published safety/efficacy papers, ILAC-accredited lab tests and Faculty of Engineering tests; Neurology: for implantables, EU market history plus long-term papers
- Section 4.2.1: for non-sterile Class IIa an origin-country FSC is tolerated in the initial file only, with a reference-country FSC due within 6 months
- Legalisation: certificates issued by reference-country bodies are verified directly; otherwise Chamber of Commerce plus Egyptian Embassy legalisation (Appendix 1 note 2)
- Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.
Effective from 2025-09-01
Source passage: List of Reference Countries: Australia, Austria, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom and United States of America [...] Devices that are subjected to specialized scientific committees' evaluation as a step prior to registration are: • Devices submitted for new registration or re-registration, which are imported from non-reference countries or locally manufactured. [...] 1) The free sale certificate that is issued by the Ministry of Health of the country of origin if it is a reference country (or a free sale certificate from one of the reference countries if the country of origin is a non-reference country) [...] For medical devices imported from non-reference countries in all classifications (I, IIa, IIb & III), the following shall be provided: - clinical trials published in reputable scientific journals. - An approved and stamped Summary of market history from centers and hospitals where the device has been used in the reference countries.
