Policies
Made-in-China: New Guideline to Boost Domestic Production of Imported Medical Devices
The NMPA released the “Announcement on Further Clarifying Matters Related to the Domestic Production of Imported Medical Devices in China (Draft)” on November 4, 2024.
The guideline introduces changes to the rules governing foreign-invested enterprises (FIEs) involved in producing imported devices domestically in China. It includes the expanded scope of domestic production application and enhanced requirements for registration (proof of common actual control, authorization from the applicants, registration system verification requirements, and commitment on materials and processes, etc.). Click HERE for our comprehensive analysis
387 IVD Reagents Proposed for Clinical Trial Exemption
NMPA published the “Clinical Trial Exempt Catalog for In Vitro Diagnostic Reagents (Draft)” on November 5, 2024, which newly-includes 387 IVDs. Feedback needs to be submitted by December 3.
The catalog proposed Class III IVDs like antibody test kits for Herpes Simplex Virus Type I (HSV I), Cytomegalovirus IgG, Toxoplasma IgG, Mumps Virus IgG, Adenovirus IgG, Varicella-Zoster Virus IgG, and test kits for Codeine, Cocaine, Morphine, Ketamine, Tetrahydrocannabinol Acid (THCA), Benzodiazepine, and various cancer antigen test kits to be exempted from clinical trials. For the full list click HERE
268 IVD Classifications Released by NMPA
The NMPA issued the “Third Batch of Medical Device Classification Results for 2024” on November 20, 2024. The document identifies 268 IVD reagents. It is a summary of classification requests submitted by overseas and domestic manufacturers. For more information click HERE
Fast-Track Approvals
Review Report Released for Boston Scientific’s DBS Directional Lead
The NMPA granted innovation approval to Boston Scientific Neuromodulation’s DBS directional lead and issued a review report on November 6.
This product is intended to be used in conjunction with a compatible implanted deep brain neurostimulator and extension lead. It delivers electrical stimulation pulses to the bilateral subthalamic nucleus (STN) for adjunctive treatment of certain symptoms of levodopa-responsive Parkinson’s disease in its mid-to-late stages when medication is insufficiently effective. Additionally, it provides stimulation to the bilateral internal segment of the globus pallidus (GPi) for adjunctive treatment of certain symptoms of advanced levodopa-responsive Parkinson’s disease when medication is inadequately effective.
The review report has four sections: product overview, pre-clinical, clinical and risk-benefit analysis. For the outline of the report, please click HERE
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- Source: https://chinameddevice.com/nmpa-news-november-2024/