Defining the correct regulatory strategy is becoming very challenging nowadays as the regulatory landscape keeps changing constantly changing and new technologies are being introduced all the time.
Following the correct regulatory strategy is crucial for Medical device companies during their product development through commercialization, as it helps them register their products successfully with health authorities and bring them to the market with minimum risk.
Global Regulatory Partners team in Japan has helped many companies explore various regulatory options and develop optimal and efficient regulatory strategies for their medical devices and IVDs for Japanese market.
Contact us to learn more about how we can help you develop the correct regulatory strategy for your medical devices and IVDs for Japanese market.
MEDICAL DEVICE CLASSIFICATION
Before legally selling a medical device on japanese market, it must comply with the regulatory requirements of the Pharmaceutical and Medical Device Agency (PMDA) and Ministry of Health, Labour and Welfare (MHLW). Classification dictates the regulatory procedure for the devices, so it is crucial to determine the correct classification and product code for the device before beginning its registration process.
In Japan, Medical devices are classified based on the risk to the human body. PMDA uses the following classification system for medical devices:
- General-CLASS I (low risk)
- Specified Controlled-CLASS II (low/medium risk)
- Controlled-CLASS II (medium risk)
- Highly Controlled-CLASS III (medium/high risk)
- Highly Controlled-CLASS IV (high risk)
Japan Medical Device Nomenclature (JMDN codes)
MHLW maintains a database of generic medical device descriptions with associated Japan Medical Device Nomenclature (JMDN) codes. This system is similar to the US FDA system of product codes or Global Medical Device Nomenclature (GMDN) system. Familiarity with the JMDN database and fluency in Japanese are essential to determine the device’s code.
If a code of a new device does not exist, the product must go through a new device pathway, and its classification is determined based on its risk according to the classification rules in Yakusyokuhatsu No. 0720022. However, the final determination of the device classification is made by the MHLW.
Global Regulatory Partners team in Japan has helped many companies classify successfully their medical devices and IVDs in Japan
Contact us to learn more on how we can help you classify your medical devices and IVDs in Japan
MEDICAL DEVICE REGISTRATION
The registration pathway for medical devices or IVDs is determined by their classification and associated Japan Medical Device Nomenclature (JMDN) as explained here below:
Pre-market submission (Todokede)
General Medical Devices (Class I) are subject to a pre-market submission that need to be file to the PMDA. This is a notification and no review assessment by the PMDA will be conducted.
Pre-market certification (Ninsho)
Class II (and a limited number of Class III) devices which have an associated certification standard (JIS), are subject to pre-market certification. Many, but not all, Japan Industrial Standards are based on existing ISO/IEC standards. The MAH/DMAH files the application with a Registered Certification Body (RCB). The process is similar to the European CE Marking process where reviews are outsourced to authorized third parties such as Notified Bodies.
Pre-market approval (Shonin)
Class II and III medical devices without a specific certification standard, are subject to the pre-market approval process. This also applies to all Class IV devices. In this case the MAH/DMAH will file a pre-market approval application with the PMDA and ultimately obtain approval from the MHLW.
Global Regulatory Partners Japan has helped many companies register successfully their medical devices and IVDs products in Japan.
Contact us to learn more on how we can help you register your medical devices and IVDs in Japan
QUALITY MANAGEMENT SYSTEM
According to the PMD Act, manufacturing facilities are subject to a Quality Management System (QMS) conformity assessment as part of the Japanese registration process. QMS conformity assessments are conducted by the Pharmaceuticals and Medical Devices Agency (PMDA) or a Registered Certification Body (RCB).
Foreign manufacturers that have chosen the Foreign Special Approval System route and hold pre-market approvals (Shonin) or certifications (Ninsho) will undergo QMS conformity assessments. Foreign manufacturers must appoint a Designated Marketing Authorization Holder (D-DMAH) to represent them in Japan.
QMS conformity assessment certification
Upon successful completion of a QMS conformity assessment, a MAH or manufacturer is issued a Certificate of QMS Conformance (Kijun Tekigoshou) by either the PMDA or RCB. Certificates of conformance are valid for five years and include the registered product name, product group (Seihingun), and manufacturing facility. Under the PMD Act, future conformity assessments focus on devices from the same product group registered with the PMDA or RCB, rather than the manufacturing facility.
Global Regulatory Partners quality team in Japan has the expertise implementing the Japanese Quality Management System in line with Ordinance 169 requirements. Our quality team can provide the following services:
- Review your quality manual and prepare a gap analysis with references to the appropriate clauses of Ordinance #169.
- Create and propose changes needed to comply with the Japan QMS regulation, including preparation of the Device Master File.
- Prepare supplemental documents as an appendix of the quality manual.
- Conduct a mock audit of your quality system prior to your PMDA conformity assessment.
- Prepare and submit the QMS Conformity Assessment application on your behalf.
Global Regulatory Partners Japan has helped many medical device and IVD companies implement and comply with QMS in Japan in line with Ordinance #169.
Contact us to learn more on how we can help you comply with Japanese QMS and Ordinance #169 requirements
FOREIGN MANUFACTURER REGISTRATION/ACCREDITATION (FMR/FMA)
Japan’s Pharmaceuticals and Medical Devices Act (PMD Act) requires both domestic and foreign companies to register applicable manufacturing facilities. This process is different from medical device or IVD registration.
Foreign manufactures must register their manufacturing facilities with the Ministry of Health, Labour and Welfare (MHLW) via the Pharmaceuticals and Medical Devices Agency (PMDA). Japanese manufacturers must register any of their domestic manufacturing facilities with their local prefectural authorities.
Global Regulatory Partners team in Japan can help you with the Foreign Manufacturer Registration (FMR) application process by preparing the following documents:
- Application for medical device Foreign Manufacturer Registration
- Business Number Registration Form to obtain a business number and its serial code (Gyosha) for each manufacturing establishment.
- Supporting documentation such as:
- self-Declaration of Medical Condition (“Someisho”) of the senior manager representing manufacturer,
- personal history of the responsible person of manufacturing facility to be registered,
- pictures, drawings, floor plans etc. showing the building(s) within the scope of registration.
Once you receive your FMR certificate, it remains valid for five years. The MHLW recommends beginning the renewal process at least five months in advance of your certificate’s expiration date.
Global Regulatory Partners Japan has helped many companies register their manufacturing sites successfully with PMDA in Japan.
Contact us to learn more on how we can help you register your manufacturing sites with PMDA in Japan.
Marketing Authorization Holder (MAH) in Japan
Foreign medical device companies, without a local presence in Japan, must designate a local MAH or DMAH who can register their products with PMDA and handle all regulatory and compliance activities, on their behalf, in Japan. This requirement has been implemented by Ministry of Health, Labor and Welfare (MHLW) to ensure that all imported drugs in Japan are under control of local entities.
Global Regulatory Partner Japan is licensed to act as your MAH or DMAH in Japan and can handle all the following activities on your behalf in Japan:
- New products registration with PMDA.
- Communications and negotiation with PMDA.
- Maintenance of products registration with PMDA.
- Products importation in Japan.
- Product quality release.
- Selection of local Distributors in Japan.
- Post-market surveillance activities.
- Adverse events reporting and management.
Global Regulatory Partners Japan acts as the MAH of many medical device and IVD companies in Japan.
Contact us to learn more on how we can become your MAH /D-MAH in Japan and handle all your regulatory affairs and compliance activities for you in Japan.
Our professionals apply their therapeutic, regulatory, and operational expertise to consistently make sure that your clinical studies are conducted with ICH guidelines and FDA regulatory requirements.
In an increasingly challenging environment, GRP has developed the experience and knowledge to find, recruit, and retain patients in clinical trials. GRP successfully deliver access to the appropriate sites and patients, developing strategies that will minimize the risks inherent in patient recruitment.
Global Regulatory Affairs clinical services include the following:
- Protocol development
- Site and investigator identification and qualification
- Site initiation and training
- Clinical monitoring
- Medical monitoring
- DSMB coordination
- Statistical analysis
- Electronic data capture
- Electronic Trial Master File
- Full service data management
- gov registration and management
- Central lab oversight and coordination
- Site quality assurance audits
- Integrated final Clinical Study Report
Global Regulatory Partners Japan has helped many companies conduct successfully their clinical trials for their medical devices or IVDs in Japan.
Contact us to learn more on how we can help you conduct successfully your clinical trials in Japan.
Medical Device and IVDs Reimbursement in Japan
Japan is a lucrative market with more than 127 million consumers. Its medical device market is third in size behind the US and European markets. Additionally, Japan, provides a universal health insurance coverage to its citizens “Kokuminkaihoken”. Obtaining the right reimbursement for a medical devices or IVD in Japan is crucial for product lunch and commercialization in this market. Obtain reimbursement coverage is very long and complex process. Companies must wait to get their product registered first before requesting for Insurance Coverage.
Products are categorized for reimbursement as follows:
- A1 (inclusive)
- A2 (designated inclusive)
- B (individual evaluation)
- C1 (new function)
- C2 (new function or new technology)
- F (Is not suitable for insurance coverage)
Global Regulatory Partners team in Japan can assist you with the following:
- Determine if your product qualifies for medical device or IVD reimbursement. Define the appropriate reimbursement class for your medical device or IVD.
- Set up the appropriate strategy for obtaining the highest level of Japanese reimbursement.
- Help you navigate through the medical device reimbursement process in Japan.
- Prepare and file the reimbursement application for your medical device or IVD to Japanese authorities.
Global Regulatory Partners Japan helped many companies receive the right reimbursement for their medical devices and IVDs in Japan.
Contact us to learn more on how we can help you with the reimbursement process of your medical devices or IVDs in Japan.