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CFDA: 99 Device Standards to be Revised in 2018 – Huge Impact on Renewals and New Registrations


CFDA announced “2018 Medical Device Industry Standard Revision Plan” on August 7th to make device regulations more consistent and stringent with international standards. It is the finalized version of the draft plan issued on May 19th.


Whether you are renewing or doing new registration, your medical device/IVD will need to meet these new technical standards. Even if your renewal (every 5 years required by CFDA) products have no changes, you still have to prove that your originally approved products from before will meet the new standards.  As a result, your originally approved products will need to go through type testing to show that you are up to date with the standards.  China Med Device, LLC has onsite test engineers to help you assess and expedite your type testing needs to shorten your renewal or new approval time.


Some industry standards have already been issued so far in 2018, including the 17 standards published on August 6th.


Standardization plans of following areas are included:


  1. Active Device

Medial Robot, Implantable Device, Medical Software, PET-MRI, Respiratory and Anesthesia Equipment, Disinfection and Sterilization Devices, Digital Radiography, Medical Extracorporeal Circulation Device, Radiation Therapy and Nuclear Medicine, Ultrasonic Equipment, Medical Laboratory and X-ray Equipment.


  1. Passive Device

Novo Surgical Equipment, Infusion Device, Assisted Reproductive Technology (ART), Sterile Catheter, Surgical Dressing, 3D Printed Dental Devices, Tissue Engineering, Nanometer Medical Device, Allogeneic Materials, Absorbable Implant Devices, New Biological Materials and Devices, Contact Lens and Intraocular Filling Materials.


  1. IVD

High Throughput Sequencing (HTS), Mass Spectrometer, IVDs for Infectious Diseases and Posterior Occipital Cervical Thoracic (POCT) System.


  1. Quality System

The Plan also addresses the quality management and the incorporation with international system. CFDA will increase the threshold for medical device quality system.


The revised industry standards will specify the modifications, effective dates, and give recommendations for registration application. CFDA will issue standards in 20 days after adoption, for the betterment of transparency of regulatory operation.


Revision of more than 300 standards for medical devices, IVDs and quality systems could be expected by the end of 2020, CFDA announced in late February. The exchange of staff and idea with other countries and international standard associations is to be speeded up, accelerating the improvement of standardization system.



For official Chinese link of the Plan, please email

Please email us the industry standards you are interested in, we can find it for you.


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About China Med Device, LLC

China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, RA, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 250+ companies’ success.



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