Q: What regulations are applicable for advertising medical devices in China?
A: The current applicable regulations include:
As there is no specific advertisement regulation for IVD, NMPA is reviewing IVD advertisement according to the requirements of medical devices.
Q: What changes are proposed in advertising requirements for IVD and medical device products in China vs the current approval system?
A: According to the new first revised opinion of Regulation on the Supervision and Administration of Medical Device (NMPA NO. 680, 2017), the advertisement reviewing process will be cancelled. However, the second revised edition resumed advertisement review process.
Therefore, the current requirements for advertisement reviewing process need to be determined based on the final version of No.680 regulation.
Q: Which division of NMPA reviews advertising and how is this changing?
A: According to Regulation No. 680 of “Regulation on the Supervision and Administration of Medical Devices”, “Medical device advertisements shall be reviewed and approved by the local NMPA where the medical device manufacturer or the import medical device agent is located, and the medical device advertisement approval document shall be obtained.”
Q: Do we know any timeline for implementation of these changes?
A: There is no specific timeline.
Q: Will advertising review remain on a regional basis where it appears that some regions are much stricter in their approvals than others or is there any proposal for a central NMPA advertising body to which all manufacturers must submit their advertising materials so we have a ‘level playing field’?
A: From the latest revision regulation, NMPA will not unified the advertising reviewing to a central NMPA advertising body.
Q: Should NMPA advertising reviewers take note of content already approved in the product licence / IFU or do they liaise with NMPA product licence dept during the advertising review process?
A: Advertisement reviewers will review the related content in product technical requirements (PTR) and IFU. As long as the advertising contents are consistent with approved PTR and IFU, they will not communicate with NMPA certificate dept unless there are contents they don’t understand and need further support.
Q: If the contract manufacturing site (and legal manufacturer) is in Guangdong region and product licence is issued by Guangdong NMPA, can advertising materials for the same device be submitted to a different regional NMPA advertising department for review?
According to Regulation NO.680 of Medical Device Supervision and Administration, “Medical device advertisements shall be reviewed and approved by the local NMPA where the medical device manufacturer or the import medical device agent is located, and the medical device advertisement approval document shall be obtained.”
The advertisements materials approved by provincial NMPA offices can be used in national level.
Q: Does NMPA make differentiation in approval process of e-commerce advertising and e-content materials vs advertising in store?
A: For advertisements published on the Internet and actually printed, there are differences during the document preparation phase. However, the reviewing and approval process is the same.
Q: Which party does NMPA hold responsible in relation to any penalties for non-compliance? Will this always be the legal manufacturer or could it also be distributor, other party or joint liability?
A: At present, from the perspective of regulations, the punishment is mainly for advertisers.
There are no requirements that the manufacturers shall take major responsibilities or joint liability.
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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.ffffffffff