Policies
Surgical Robots and 36 Medical Devices Will be Tariff Free
Two major changes on medical device tariffs have been made, with two announcements from China Ministry of Finance:
- From January 1, 2023, China has implemented a provisional import tax rate lower than the MFN (Most-Favored-Nation) rate for 1,020 commodities. Among them, 13 types of medical devices are on the list, including detachable coil, intracranial thrombectomy stent and artificial heart valve, etc.
- From July 1, 2023, 37 types of medical devices will achieve zero import tariffs, including surgical robots, ECG therapy device, B-ultrasound diagnostic instrument, patient monitor and endoscope, etc.
Tariff heading for surgical robots has also been added to the tax catalog. For more information, please click HERE
Intellectual Property: Submitting Master File to Protect Your Raw Materials
NMPA published a notice “Further Clarify the Registration and Use of Medical Device Master Files” on January 18, 2023. It reiterates that master file system is to protect the intellectual property rights of the master file owner (raw materials’ manufacturers) and facilitates the medical device applicants’ selection of raw materials and key components, simplifying registration.
The master file is submitted directly by its owner and NMPA will review the file data when the device application begins. The submission of the master file is voluntary. For more information, please click HERE
Guidelines & Standards
Thirty-Two Industry Standards Issued in One Day
NMPA published thirty-two industry standards on January 16, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions.
Among them, the mandatory standards include those for hemodialysis equipment, radiofrequency hyperthermia equipment, automatic non-invasive blood pressure monitor, patient monitor, pulse oximetry equipment, surgical equipment using robotic technology, etc. For the full list of the standards please click HERE
Fast-Track Approvals
2022 Innovation Approvals Review: Cardiovascular, Gastro/Urology, Neurology, and Radiology among the Most
32 innovation approvals have been granted by NMPA in 2022. Among them are eight cardiovascular and seven gastrological and urological devices. Neurological and radiological have six approvals respectively.
Overseas manufacturers who received approvals include Medtronic, Ethicon and BioFire Diagnostics. Click HERE for our comprehensive review
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- Source: https://chinameddevice.com/nmpa-roundup-january-2023/
