The Monthly NMPA (CFDA) News Roundup covers government announcements, policies, standards, guidelines, QA/recalls/AEs, and new approvals in medical devices and IVDs in China. It is edited by ChinaMed Device, LLC (www.ChinaMedDevice.com), a consulting firm specializing in China NMPA (CFDA) regulatory affairs, CRO and market access services.
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Cardiac implants, brain implants and prothesis as the first trial
Some are classified as medical devices for the first time
Eight special requirements for software manufacturers
The UDI system has been established to “adequately identify medical devices through their manufacturing, distribution and use in China”. The label of all devices in China will include “a unique device identifier in human- and machine-readable form, benefiting traceability in product registration, clinical, adverse event reporting, recall and medical insurance.”
For our comments on the UDI implementation plan, please click HERE.
2. National Institutes of Food and Drug Control (NIFD) published the First Batch of Medical Device Classification Results on July 18. This document, classifying Class III (56 items), Class II (78 items), Class I (53 items) and Non-Medical Devices (5 items), serves as a guide to manufacturers for ambiguous device classifications.
The Classification Results involves devices in anesthesiology, cardiovascular, dental, gastroenterology and urology, obstetrical and gynecological, ophthalmic, orthopedic, pathology and molecular diagnostics.
Some are classified as medical devices for the first time. For example, the regulatory status of some cosmetic devices, including ultrasonic skin treatment equipment, ultrasonic electrical stimulation device and electrotherapy ultrasound therapy device, is changed from non-medical device to Class II device.
For our comments on the Classification Results, please click HERE.
3. Center for Medical Device Evaluation (CMDE) issued Notice on Requirements for Medical Device Electronic Submission on July 10. It lists three requirements which are to be implemented on August 1, 2019.Center for Medical Device Evaluation (CMDE) issued Notice on Requirements for Medical Device Electronic Submission on July 10. It lists three requirements which are to be implemented on August 1, 2019.
a. When registering imported device, only the probative documents, declaration of conformity and labels shall contain the notarized documents issued by the notary body at the place where the applicant is located;
b. Considering the folder structure of Regulated Product Submission Table of Contents (RPS ToC), the page number of the registration materials under the heading of any level can be compiled separately;
c. The Technical Requirements in the electronic registration application materials should be contained in a single copy.
For our comments on these requirements, please click HERE.
NMPA published Technical Review Guideline on Dental Digital Impression Instrument on July 4. It contains the Product Technical Requirements (PTRs) and PTR template for reference.
NMPA announced establishments or revisions of 24 Medical Device Industry Standards on July 30.
For our comments on these standards, please click HERE.
NMPA announced Recall Notices to five imported medical devices in July:
NMPA granted Innovative Device Status to three manufacturers on July 26.
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.