Shanghai Municipal Food and Drug Administration (“SFDA”) issued [2017] No. 205 on 10^th Oct 2017 for the purpose of work arrangement on the further supervision and administration on the medical device operation enterprises in Shanghai. The main work arrangement covers the following points.

1. Further administration on the whole course of the medical device operation enterprises;

The FDA at the district level shall strengthen on the halfway and afterward administration on the medical device operation enterprises, especially checking the operation, storage and delivery status for whom the business venue and the warehouse are located across two districts. For those companies positively applying for the cancellation the license, it should be strictly checked whether it is still involving in any uncompleted investigation.

2. Further supervision on the medical device information tracing;

The full and complete system should be established for information tracing, especially for the Grade C medical device operation enterprise. The company should apply for the full information such as the product information, the supplier, and the purchaser in time.

3. Further administration on the recalling of the medical device with problem;

For the medical device with problem, the domestic designated agent for the overseas medical device manufacturer shall take the liabilities to find out the reason for the problem, make the report, recall of the problem products and trace the afterward situation.

4. Further administration on the label and specifications for the imported medical device;

According to the regulations, the imported medical device shall be attached with the Chinese specification and Chinese label. To add the label in China is strictly prohibited.

Dongjin comments:

The medical device operation enterprise should have a self-check and take care of the following points.

1. Whether the company changed the business place and warehouse without authorization?
2. Whether the company operated according to the regulation and the Measures for Medical Equipment Quality Management?
3. For Grade C medical device companies, whether the full and completed system for information tracing was established? Whether it made the online report in time? Whether the information as the product, the supplier and the purchaser was filled in full and complete?
4. For the imported medical device, whether the Chinese specifications and the label were attached? Whether the company ever added the label in China without authorization?

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Mr. Mike Chang

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Email: mikechang@shanghaiinvest.com