China Updates Quality Management Standards for Medical Device Operations

Starting in July, China’s NMPA will enact its revised policy on quality medical standards for medical operations. The old version issued in 2014 will no longer be in use. The new measures cover a variety of topics for good supply management. For example, additional requirements are needed when dispensing medical devices via automated vending machines. Warehouses should utilize better computer systems to account for their inventory and in addition improve their quality system communication for warehouses in different administrative regions. Warehouses should follow labeling and packaging requirements, keep medical and non-medical products separated and maintain appropriate temperatures. Shipping instructions should include details of the seller/buyer, the transportation company name, details on the device being delivered, etc. Finally, after sales service must be performed in a quality manner by the seller or third-party after sales service provider.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

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