China Regulatory Update on Feb 26, 2020
I. News Roundup
1. NMPA New Requirement for Registration Renewal and Supplementary Dossier Submission Time
On February 26, 2020, CMDE (Center For Medical Device Evaluation, NMPA) issued a notification that due to the break of new coronavirus, manufactures can submit the renewal and supplementary dossiers later after the vanish of emergency situation. China Med Device could help submit the relevant application letter to NMPA for renewal or submission delay.
Link: https://www.cmde.org.cn/CL0004/20517.html
2. NMPA Requirement on the Connection Mode Between Dental Implant and Abutment
On February 25, 2020, CMDE clarified about the connection mode between dental implant and abutment should be specified in the product structure and composition. Meanwhile, for different connection modes, relevant research on system compatibility verification such as torsion resistance, tightening torque, and fatigue limit should be performed separately.
Link: https://www.cmde.org.cn/CL0113/20514.html
3. NMPA Requirement on Disinfection and Sterilization Dossiers for Reusable Accessories of Active Devices
On February 25, 2020, CMDE clarified about what should be concerned about the reusable accessory disinfection and sterilization data for active medical devices. Reusable accessories should be disinfected or sterilized before use. IFU should specify the specific disinfection / sterilization method (such as the disinfectant used, disinfection or sterilization equipment), and important parameters of the disinfection / sterilization cycle (such as time, temperature, and pressure). The research data should provide the basis for determining the disinfection / sterilization method, the confirmation data for the disinfection / sterilization effect, and the tolerance of the recommended disinfection / sterilization method.
Link: https://www.cmde.org.cn/CL0113/20515.html
II. New NMPA Approvals
1. New Dental Products Approved
On February 25, 2020, NMPA approved the imported dental products, including multilink hybrid abutment and tooth whitening agent. The registration applicants are B.J.M.LABORATORIES LTD. and Beyond International Inc. respectively.
Link: https://www.cmde.org.cn/CL0151/20508.html
2. Priority Pathway Approval
On February 25, 2020, CMDE issued a notification that the orthopedic surgical navigation and positioning system of TINAVI obtained the priority pathway approval, because this product is listed in the national key research and development plan for medical devices. Priority pathway could accelerate the technical review from CMDE and shorten the registration timeline. China Med Device could help evaluate and offer support on priority registration.
Link: https://www.cmde.org.cn/CL0004/20513.html
3. Three New COVID-19 Assay Reagents Approved
On February 22, 2020, NMPA approved three COVID-19 detection products of three companies, including two colloidal-gold antibody assay reagents and one nucleic acid assay reagent based on thermostatic amplification chip method.
Link: https://www.cmde.org.cn/CL0004/20486.html
III. Guideline Update
1. Two NMPA New Requirements for Registration Review of COVID-19 Reagents
On February 12 and 25, 2020, CMDE released two notifications on “Key Points of Technical Review for Registration of COVID-19 Nucleic Acid Assay Reagent” and “Key Points of Technical Review for Registration of COVID-19 Antigen/Antibody Assay Reagent (Trial)” respectively. China Med Device suggest manufactures to follow the new requirements to do relevant registration.
Link:
https://www.cmde.org.cn/CL0050/20447.html
https://www.cmde.org.cn/CL0050/20512.html
2. New NMPA Provisions on Supplementary Dossier
On January 16, 2020, CMDE issued a notification on the new requirement in supplementary dossiers for medical device registration. Supplementary dossiers are required to be submitted within 1 year since the date of NMPA Supplementary Notice. China Med Device can help manufacturers address questions from reviewer and complete the registration.
Link: https://www.cmde.org.cn/CL0025/20344.html
- New Guidelines for Allograft Medical Devices (draft) and X-ray Computer Tomography Equipment
CMDE issued a notice to collect comments on The Guidelines for Technical Review of Viral Inactivation Process Validation of Allograft Medical Devices (draft) and The Guidelines for Predicate Clinical Evaluation of X-ray Computer Tomography Equipment (draft) on January 9 and 15, 2020 respectively. Allograft Guideline involves in some IVF products etc., and China Med Device can help manufacturers to evaluate the gap between your products and new guidelines.
Link:
https://www.cmde.org.cn/CL0063/20299.html
https://www.cmde.org.cn/CL0064/20343.html
IV. AE and Recall
1. Biomet Orthopedics Recall
On January 11, 2020, Biomet Orthopedics voluntarily recalled its artificial Hip Modular System due to the product did not match the label. Since China NMPA enhances the post-market surveillance, China Med Device can help manufacturers review all labels in compliance to China regulations.
Link: http://www.nmpa.gov.cn/WS04/CL2135/374182.html
About China Med Device
ChinaMed Device provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston (China Med Device) and Beijing (Bradynuoen), we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification.
Offices:
China Med Device, Boston, US
Bradynuoen, Beijing, China
Address: Rm 1501-1502, East Ocean Centre, Jianguomen, Beijing, China
Tel: +86 10 65155991, +86 18600392020
Email: info@chinameddevice.cn
