In March 2023, the Japanese MHLW issued a new regulation to incorporate cybersecurity into the Japanese Essential Principles (Article 12-3). To give more clarification on vague terms and definitions, the MHLW issued a new notice as Q&A in August 2023, which includes examples of how submission dossiers shall be presented.

References:

Q&A on New Essential Principle of Cybersecurity

Additional explanation by MHLW to No. 67 Notification about Cybersecurity