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Regulatory Reshuffle in China Brings Sweeping Reforms to Device Oversight
Devices Regulatory Affairs
Multinational medical device companies operating in China will want to keep a close eye on the country’s new State Market Regulatory Administration.
The newly formed SMRA will absorb and oversee responsibilities previously held by the China Food and Drug Administration, establishing a new State Drug Administration that will maintain its own branches at the provincial level, leaving post-approval enforcement to municipal and country branches.
The SMRA will also oversee the responsibilities of the State Administration for Industry and Commerce, the General Administration of Quality Supervision, Inspection and Quarantine, the Certification and Accreditation Administration; and the Standardization Administration of China.