China suspends bone graft material from HansBiomedCorp (South Korea) following a remote off-site inspection by the National Medical Products Administration (NMPA).
The medical device under inspection was an allogeneic bone repair material:
- English name: ExFuseBoneGraft
- registration number: 20193130564
- production address: 64, Yuseong-daero1628beon-gil, Yuseong-gu, Daejeon, Korea
The inspection found that the production process of the product had problems such as failure to take effective control measures for key raw materials and insufficient environmental monitoring in the clean area.
Therefore, in order to ensure the safety of devices used by the public, and in accordance with the relevant provisions of the “Regulations on the Supervision and Administration of Medical Devices” and the “Measures for the Supervision and Administration of Medical Device Production”, the NMPA has decided to suspend the import, operation and use of allogeneic bone repair materials from HansBiomedCorp in South Korea from now on.
Medical device companies are required to adhere to the Good Manufacturing Practice for Medical Devices – more information can be found here.
As this product is an implantable medical device, it must also comply with the “Medical Device Production Quality Management Code Appendix for Implantable Medical Devices”.
Consequences of non-compliance:
According to Article 86 of the Regulations for the Supervision and Administration of Medical Devices, the department in charge of drug supervision and administration shall order rectification and confiscate the medical devices produced and operated illegally:
- if the amount of the medical devices produced and operated illegally is less than 10,000 yuan, a fine of more than 20,000 yuan and less than 50,000 yuan shall be imposed;
- if the amount of the goods is more than 10,000 yuan, a fine of more than 5 times the value of the goods and less than 20 times the value of the goods shall be imposed.
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