Japanese The Regulatory Process for Medical Devices

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Japanese The Regulatory Process for Medical Devices
Japanese The Regulatory Process for Medical Devices
Japanese The Regulatory Process for Medical Devices
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Japanese The Regulatory Process for Medical Devices and fee for registration medical devices

Step 1: Determine classification of medical device according to the Pharmaceuticals and Medical Devices Act (PMD Act) and Japanese Medical Device Nomenclature (JMDN) codes.

Step 2: Appoint an MAH in Japan

Step 3: Japanese manufacturers must register domestic facilities with local prefectural authorities. Foreign manufacturers must submit a Foreign Manufacturer Registration (FMR) application to the Pharmaceuticals and Medical Devices Agency (PMDA).

Step 4: Implement Quality Management System (QMS) that complies with the PMD Act and Ministry of Health, Labour and Welfare (MHLW) Ordinance #169. Ordinance #169 is based on ISO 13485.

Step 5: Submit the application

  • Class I: Submit Pre-Market Submission to Pharmaceutical and Medical Devices Agency (PMDA). All documents must be in Japanese.
  • Class II (Specified Controlled medical devices): Submit Pre-Market Certification application to a Registered Certified Body (RCB) authorized to issue certifications. All documents must be in Japanese.
  • Class II (Controlled medical devices), Class III (Highly Controlled medical devices), Class IV (Highly Controlled medical devices): Prepare Pre-Market Approval application as well as registration dossier in Summary Technical Document (STED) format. Submit documents to PMDA. All documents must be in Japanese.

Step 6:

  • Most Class I devices do not require QMS conformity assessment (MHLW Ordinance #169 documentation is not required for most Class I device applications. However, some Class I device manufacturers do require QMS certification, including Class I NEW devices (i.e., no JMDN code).
  • Class II – Specified Controlled medical devices: QMS audit by Registered Certification Body (RCB).
  • The remain Classes: QMS audit by PMDA. On-site audits are typically required for “New” devices with no existing JMDN code, Class IV devices, and those requiring clinical investigations.

Step 7: Your QMS certificate will be issued by the PMDA or your Registered Certification Body.

Step 8:

  • Class II (Specified Controlled medical devices): Pre-Market Certificate issued by RCB.
  • Class II (Controlled medical devices), Class III (Highly Controlled medical devices), Class IV (Highly Controlled medical devices): Pre-Market Approval certificate issued by MHLW.

Step 9: A reimbursement application should be filed with Economic Affairs Division of MHLW if applicable.

Step 10: You may now begin marketing your device in Japan. Approvals do not expire (Device registrations do not expire. However, QMS certificates are valid for five years and must be renewed six months prior to expiration. Pre-Market Certification applications may also be subject to annual surveillance audits. The schedule will be determined by the RCB or PMDA.)

***** Prices in US Dollars for a single device. From $5,000 to $50,000 or more. Overall cost includes registration application fees, product testing, in country representation, submission preparation consulting and translation of registration documents but not IFU. Does NOT include cost of implementing or auditing a quality management system.

Japanese The Regulatory Process for Medical Devices and fee for registration medical devices – Source Emergo

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