State Administration for Market Regulation, Measures for Oversight of the Dealing in Medical Devices
国家市场监督管理总局医疗器械经营监督管理办法
May 06, 2022 | BY
Susan MokPermit exemption for sale of medical devices are added to revised regulations.
Main contents: A medical device registrant or filer may sell such device itself or, alternatively, may engage a medical device dealer to sell the medical devices it has registered or filed for the record (Article 3).
The dealing in medical devices shall be subject to administration by class based upon the degree of risk that a medical device poses.
The dealing in Class III medical devices shall be subject to administration by permit, that of Class II medical devices to administration by record filing and that of Class I medical devices shall require neither a permit nor record filing (Article 4).
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