# Global Regulatory Challenges for Medical Devices: Impact on Innovation and Market Access
## CE Marking
### Japan
#### 4.3.2 Market Authorization  
In Japan, the regulatory process for medical devices varies depending on their classification and associated risks [73]. To facilitate the regulatory review process, the MHLW issues comprehensive review guidelines that provide manufacturers with detailed insights into the major technical requirements, acceptance criteria and evaluation criteria employed by regulatory authorities. While these guidelines do not give specific performance limits, they play a crucial role in promoting a more efficient and transparent review process. By adhering to these guidelines, manufacturers can simplify the regulatory approval process and expedite the entry of their medical devices into the Japanese market [74; 75]. The Self-Declaration Process applies to the lowest risk devices. In this process, the manufacturers must submit a DoC to the PMDA. This declaration asserts that the device complies with relevant regulatory standards. While there is no formal review by regulatory authorities, adherence to these standards is mandatory to ensure the safety and efficacy [73]. Third-Party Certification, which is required for controlled risk devices, involves certification by independent organizations registered by the MHLW. These certification bodies evaluate the device's design, manufacturing processes and quality control measures to ensure compliance with established standards for quality, efficacy and safety [72]. They also notify the MHLW of certification decisions, ensuring transparency and accountability in the certification process. The process where there is an MHLW's Approval and it is reviewed by the PMDA is mandatory for higher-risk devices. The PMDA oversees this process, evaluating devices against specific approval criteria. These criteria are often based on international standards such as ISO or IEC, ensuring a thorough assessment of device safety, efficacy and quality. The PMDA's rigorous evaluation aims to protect public health by ensuring that medical devices meet stringent regulatory requirements before entering the market [72]. Class I device's manufacturers undergo the self-declaration process, submitting a DoC to the PMDA to assert compliance with regulatory standards. This process emphasizes self-certification with mandatory adherence to ensure device safety and efficacy [72]. For class II devices, a third-party certification is required. Certification bodies evaluate the device's design, manufacturing practices and quality controls to certify compliance with standards for quality, efficacy and safety. Transparency is ensured through reporting to the MHLW [72]. Class III and IV devices need approval from the MHLW, reviewed by the PMDA. The PMDA evaluates these devices against specific approval criteria, often aligningwith international standards. This stringent evaluation ensures devices meet rigorous safety, efficacy and quality standards before market entry [72]. **Japanese Medical Device Nomenclature**  
The Japanese Medical Device Nomenclature (JMDN) is a standardized system used to identify medical devices in Japan. It was created based on the 2003 version of the GMDN and was implemented in 2005 [14; 72]. Each medical device is uniquely identified by an eight-digit JMDN code. Codes starting with 1, 3, or 4 are based on GMDN, while those starting with 7 are unique to JMDN. The first five digits are derived from the GMDN code, with an additional three digits appended to form the JMDN code. If the last three digits are 000, it means the GMDN is not subdivided. The first of the three added digits indicate the presence of biological materials or drug substances. The second digit reflects no differences in risk classification, but there may be minor differences in the device. The third digit indicates the differences in risk classification [72]. Figure 9 provides a comprehensive outline of the JMDN code, along with some examples. The JMDN is not updated simultaneously with the current GMDN.