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About CMDRD
Issuance date
2016
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before2008
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Main Enabling Legislation
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Medical Device Inventory
Regulations
2011
Registration
Technical Review Guiding Principles of Analysis Performance Evaluation (Accuracy- Recovery Rate Test) for IVD
2011
Registration
Technical Review Guiding Principles of Analysis Performance Evaluation (Accuracy-Methodology Comparison Test) for IVD
2011
Registration
Technical Review Guiding Principles of Registration for Breast Implants
2011
Registration
Technical Review Guiding Principles of Registration for Care Product of Contact Lens
2011
Use
Administrative Measures for Medical Equipment of Medical Organisation(MOH)
2011
Reevaluation-Recall
The Provisions for Medical Device Recall (interim)(MOH order No. 82 2011)
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