Regulatory Alerts2004-07-13
Added · Updated
Regulations on the Management of Medical Devices and Medical Equipment
The Ministry of Health amends the 1999 Regulations on the Management of Medical Devices and Medical Equipment to update definitions, expand the scope of regulated devices, and establish new licensing and reporting requirements for manufacturers and importers. The amendments introduce specific financial thresholds, such as a 1% reserve requirement for certain entities, and mandate detailed record-keeping and quality control measures for medical device distribution. These changes apply to all entities involved in the manufacturing, import, and distribution of medical devices within the jurisdiction, with the revised regulations becoming effective on January 1, 2004.
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