Regulatory Open Forum

What are the import regulations to import syringes to China to initiate a clinical trial? Related study protocol and IMPD have been approved by the Chinese agencies, what else needs to be approved to import syringes to China?

Dear AA, China imports is regulated by the customs, not the regulatory authorities such as NMPA.  Not sure if your syringes filled with drugs or not or on the special restricted list or not.  We are a full service medical device CRO in China. I can share with you our experience. We have helped our clients import their devices and consumables into China to support their local China clinical trials or the necessary tastings at the testing centers. A couple of questions with explanations.  Once they get to China cleared by the customs, do you need to send them to a centralized location and then distribute to each trial site?  If it is just a one shot importation, check with your local China trial CRO to see if they have an importation and customs clearance agency that they work with. It is the easiest and pretty straightforward.  On the device side, we usually send our clinical trial clients instructions before shipment to make sure the pick list, invoices, what harmonization code to use, what value to declare especially if they are consumables to support a trial, etc.  Make sure your customs clearance agency review the shipment paperwork before hand to avoid unnecessary delays or extra duty or taxes at the customs. If the package is small, UPS, Fedex both can ship and import but sometimes the customized MedTech advices on how and what in customs clearance may be lacking.  In essence, you have the necessary approval paper work from China already already.   

------------------------------
Grace Fu
China Med Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com

Original Message:
Sent: 22-Nov-2023 18:23
From: Anonymous Member
Subject: China Import regulations

This message was posted by a user wishing to remain anonymous

What are the import regulations to import syringes to China to initiate a clinical trial? Related study protocol and IMPD have been approved by the Chinese agencies, what else needs to be approved to import syringes to China?