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Asia On The Mark Issue 26 (Summer 2008)

Overview of the China’s Medical Device Approval Process

Regulatory Approvals by Device Classification

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.

Approval Process

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

Product Specification

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.

Testing Requirements

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 60601-1 report, out of the 110 items, results of 61 items from the reports generated by a foreign laboratory could be accepted. It is very important that during the testing procedure the applicant or their registration agent establish very close and clear communication with the testing center officials. Any specific queries raised by the testing center should be answered immediately. It is most crucial that there will be no misunderstanding from either side in order to avoid conducting the wrong testing and/ or missing the critical testing which could happen quite easily. Any misunderstanding in this respect could result in valuable time lost and in certain cases the whole procedure may have to be repeated.

For both Import and Local Manufacturing licenses approval of Class I products, no sample testing will be required.

High Risk Devices - Clinical Trials

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.

Expert Panel

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-vitro Diagnostic Device (IVD) is an important category and is grouped as a separate classification under the Medical Device umbrella. In 2007 SFDA established detailed guidelines and regulations for registration, and clinical trial requirements for this major category. Even though the registration procedure is similar to the other device category, the technical dossier requirement is much more complicated than the other general devices. As a matter of fact, the biological IVD requirement is getting to be very close to the drug requirement.

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.

For more information, contact a customer service professional at the UL location near you. Or visit http://www.ul.com/hitech/medical/.

by Janice Ma, ChinaGate

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In this Issue
UL’s Photovoltaic Technology Center of Excellence
New Holographic Label to Combat Counterfeiters
ENEC Mark Scheme Revised
XVIII World Congress on Safety and Health at Work
General Differences between UL and IEC Standards for Small Household Kitchen Appliance (Part 2)
Overview of the China’s Medical Device Approval Process
Mobile-UL engine started up
Energy Meter Testing in New Zealand
UL University
UL Standards
News Bites


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