Since 20th April, all medical products for export customs clearance require CIQ (Customs Inspection Quarantine) samples must be submitted in advance and the approval process takes 3-10 days.
Pre Shipment Inspection |
|
Commodity |
Type of Inspection |
Medical |
All documents and cargo will be inspected* |
Non-Medical |
Inspection may take place* |
*Cartons may be opened and checked against outer carton information and documentation any cargo deemed to be for “Medical” use, will be stopped.
Non Medical Equipment
Shipment Requirements |
||
Documents |
|
|
All paperwork including packing certificate need show factory information and all information must be consistent. |
|
|
Each package requires a certificate, the certificate must include - Certificate # - Production lot number - Factory name and address - Production date - Validity |
|
|
Factory confirmation that product is “non-medical” |
|
|
Product packaging or documentation (including certificate #) must not include any medical words/references – for example packing must not reference FDA / CE / en14683 mark |
|
|
Testing / QC report |
|
|
Other |
|
|
The commodity code used & show in device registration certificate and on export documents, must be on the approved list (see appendix) |
||
All carton and boxes need show - Certificate # - Production lot number - Factory name and address - Production date - Validity - Medical devices licence number This information must be printed on the carton and not on outer label, Ligentia can provide outer carton printing services if required |
In order to strengthen the export quality supervision of non-medical masks, all cargo pending customs clearance (ex PVG) for PPE will be require the following
All non-medical standard masks for export must meet either Chinese or equivalent quality standards
- Non-medical mask export enterprises must submit an electronic or written joint declaration (Exporter and importer*) to confirm that the product complies with China export regulations
NB The importer accepts the quality standards of the purchased products and does not use them for medical purposes. The customs will check and release the enterprise list provided by the Ministry of Commerce.
A full list of non-medical mask manufacturing enterprises that have obtained foreign standard certification can is located on the China Chamber of Commerce for Import and Export of Medicines and Health Products website (Refer to Appendix for version dated 28/04/2020)
For a list of of products and enterprises that have failed to obtain relevant foreign standards you can review General Administration of Market Supervision website - www.samr.gov.cn
Medical Equipment
Shipment Requirements |
||
Documents |
|
|
|
Manufacturers production business license |
|
|
Manufacturers Medical device registration certificate, to include - Certificate # - Production lot - Factory name & address - Production date - Certificate validity date |
Commodity code used must match export documentation. Each package must include certificate |
|
Manufacturers Medical material declaration with official seal |
|
|
Confirmation that Medical devices are licensed |
|
|
QC report |
|
Other |
|
|
The commodity code used & show in device registration certificate and on export documents, must be on the approved list (see appendix) |
||
All carton and boxes need show - Certificate # - Production lot number - Factory name and address - Production date - Validity - Medical devices licence number This information must be printed on the carton and not on outer label Ligentia can provide outer carton printing services if required |
If you have an enquiry please complete the sales enquiry form or contact the Customer team.
Comments
0 comments
Please sign in to leave a comment.