# China NMPA Inspection - British company - December 14, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/british-company/33a75f56-16d9-4481-9f20-bebf972b338c/
Source feed: China

> China NMPA unannounced inspection for British company published December 14, 2017. The State Food and Drug Administration (SFDA) of China announced on December 14, 2017, the immediate suspension of imports for specific medical device

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 152 of 2017 from the State Administration for Market Regulation on the Suspension of Imports of Calcium Sulfate and Absorbable Artificial Bone Powder Products from Biocomposites Ltd., UK
- Company Name: British company
- Publication Date: 2017-12-14
- Product Type: devices
- Summary: The State Food and Drug Administration (SFDA) of China announced on December 14, 2017, the immediate suspension of imports for specific medical device products from Biocomposites Ltd., a UK-based manufacturer. This action followed a recent on-site inspection of the company's overseas operations, with the decision effective December 11, 2017.The inspection revealed significant discrepancies concerning Biocomposites Ltd.'s calcium sulfate and absorbable artificial bone powder products. While these products were registered separately in China, they were found to be shipped into the country in combination packages. Crucially, the syringes and water for injection included within these inner combination packages were not registered in China. This configuration was inconsistent with the products' declared registration details, raising concerns about compliance.These findings strongly suggested violations of China's regulatory framework, specifically the "Regulations on the Supervision and Administration of Medical Devices" and the "Measures for the Administration of Medical Device Registration." To safeguard public health and ensure the safe use of medical devices, the SFDA invoked Article 55 of the aforementioned Regulations (State Council Decree No. 680).As a direct consequence, the SFDA mandated the immediate suspension of imports for all combination packages containing calcium sulfate and absorbable artificial bone powder from Biocomposites Ltd. Furthermore, the regulatory authority committed to initiating a comprehensive investigation into the related cases to address the non-compliance thoroughly.

Company: https://www.globalkeysolutions.net/companies/british-company/78cd6edc-2bd3-4961-aff5-d3b2fb90e467/