Ekimz Enterprise is affiliated and represents HuaMei Medical Group -
Regulatory Approvals by Device Classification in China
In China, review and approval of Medical Devices are under the jurisdiction of the Central State Food and Drug Administration Bureau (SFDA) as well as the other municipal branches that are subsidiaries of the central SFDA. Registration of Medical Devices requires both the Import Device license approval and the Local Manufacturing Devices license approval. Class I,II and III devices that are imported and Class III devices that are manufactured locally are subject to direct review by the central SFDA, whereas Class I and II devices manufactured locally are reviewed and approved by the relevant branch of the municipal bureau.
Class I: Medical Devices are those for which safety and effectiveness can be ensured through routine administration.
Class II: Medical Devices are those for which further control is required to ensure their safety and effectiveness.
Class III: Medical Devices implanted into human body, or used for life support or sustenance, or pose potential
risk to human body and thus must be strictly controlled in respect to safety and effectiveness.
There are three key steps in the Medical Devices approval process:
1. Product Technical Specification Establishment
2. Product Testing Completion
3. Dossier Review and Approval
Prior to sending samples for testing, each product specification will have to be set up according to SFDA requirements. The product specification should be written in accordance with the guideline of the published international standard (GB) of similar products or based on specific industry requirements. Currently, the majority of the GB standard comes from the basis of IEC and ISO.
Sample testing will have to be conducted in the SFDA approved and appointed testing centers. Each center, with its own particular experience and expertise, will have different testing responsibilities. During the testing procedure, the Chinese testing centers are authorized to recognize and accept certain parts of the testing reports generated from foreign laboratories, as long as these laboratories are credible and internationally well known. For example: In the electric safety IEC 60601-
For both Import and Local Manufacturing licenses approval of Class I products, no sample testing will be required.
High Risk Devices -
The new Medical Device regulations also stipulate that for High Risk, New Innovative products, after product testing has been completed, prior to SFDA application submission, another step, i.e. clinical trial, will be required to demonstrate the product efficacy and safety. Clinical trial will have to be performed in the SFDA approved and assigned hospitals. Again, given the different experience and expertise of the hospitals, the individual hospital will be responsible for certain types of clinical trial requirements. All clinical trials conducted must adhere strictly to Good Clinical Practice (GCP) requirement.
In general, the SFDA Medical Device Bureau will review most of the applications; however, for High Risk and New Innovative products, SFDA will organize
Expert Panel meetings to seek the assistance of field experts in reviewing the application. In such panel meetings, manufacturers are invited and they can bring in their own experts to participate and discuss with the appointed experts on any technical queries in the application dossier.
IVDs – Similar but Different In-
Knowledge and Experience is Key to Success
For the time being, the Medical Device application process is not too complicated. However, the regulation is relatively new and is still in its infancy, particularly the clinical trial requirement. So during the whole process, there could be some subjective elements that could affect the outcome of the approval process. It is therefore our recommendation that for the foreign manufacturers who want to register their products in China, the first step is to have a thorough understanding of the Chinese registration process. It will not hurt to check the registration route of a similar product, particularly if someone has already experienced certain difficulties. A good registration strategy can definitely save the manufacturer a lot of time and money, and help enhance a fast track entry into the vast lucrative Chinese market.
Our Medical Consulting Service includes:
Copyright @ 2013-
Ekimz Inc is an independent sales representative, representing multiple manufacturers, wholesale distributors and other suppliers of personal protective equipment and other healthcare products. Ekimz Inc itself does not manufacture or produce the medical supplies. Our mission is to facilitate transactions between those who have inventory and those in need. Please be aware that any transaction(s) involving the purchase and sale of medical supplies will take place directly between the purchaser and either the manufacturer or distributor. We strongly encourage all purchasers of medical supplies to conduct their own due diligence regarding any manufacturer or distributor with whom they do business, and to inspect all products before acceptance.
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