9 July 2014
Online CBA: What Are the Examination and Approval Procedures for Exporting Medical Appliances into China?
Q: What Are the Examination and Approval Procedures for Exporting Medical Appliances into China?
A: Under the Regulations on the Administration and Supervision of Medical Appliances, for medical appliances imported for the first time, the import enterprise must submit samples and all necessary product information, such as instruction manuals, quality standards and examination methods, together with certification issued by the exporting country (or region) for their production and sale to the China Food and Drug Administration (CFDA) for examination, approval and registration. It is only after obtaining the import registration certificate that the enterprise may proceed to customs to complete import formalities.
Application procedures for import registration certificate:
(The HKTDC provides one-on-one China Business Advisory Service free of charge to assist companies in resolving problems encountered when doing business in China. For enquiries and appointments, please call (852) 1830 668 or register online.)