Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

The big regulated Markets -Japan

CDx

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– Companion Diagnostics (CDx) are governed under the Drug Law in Japan (PMDA)

– Class III, require Ministerial Approval route

– Need external clinical studies (need Japanese specimen data; data from clinical study conducted in foreign countries is acceptable)

– In general, CDx test are given priority review by PMDA for co-development of Rx/CDx (9-12 months)

– According to MHLW Notification on July 2013, simultaneous approval of CDx and the Drug is required.

– For simultaneous approval, the CDx dossier shall be submitted at the same time or if not possible, within 1 month of the NDA in principle. Clinical Performance Data;

– CDx submission; CDx (or Final Prototype CDx) should be used as Clinical Trial Assay (CTA) for the patient selection in Drug Clinical Trial and the diagnostics data and the clinical outcome from the clinical trial can only be used for CDx registration.

Other issues

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Stability must be real time at approval

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The big regulated Markets -China

 China legislation is multi-level for IVDs ● Administrative Regulations – Supervision and Administration Regulation of Medical Device State Council Decree 650 – Major change from 1 st June 2014 ● Department Regulation – Provisions for Medical Device Registration CFDA Order 4 – Provisions for IVD Registration CFDA Order 5 ● Normative Documents – Announcement on requirement of registration document and format of approved certificate for medical device

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