Yes, there are specific labeling and packaging requirements for medical devices in Japan as per PMDA regulations. Some of the key requirements include:
1. Product Labeling:
- The label must include the device's name, intended use, manufacturer's name and address, batch/lot number, expiration date, and any warnings or precautions.
- Labels must be in Japanese, or if in another language, a Japanese translation must be provided.
2. Instructions for Use (IFU):
- IFUs must be provided in Japanese and include information on the device's proper use, handling, storage, and maintenance.
- IFUs must also include information on contraindications, warnings, and precautions.
3. Packaging:
- Packaging must protect the device during transportation and storage.
- Sterile devices must be packaged in a way that maintains sterility until the point of use.
4. Unique Device Identification (UDI):
- Devices must have a UDI compliant with international standards (e.g., ISO/IEC 15459) for tracking and traceability purposes.
5. Medical Device Nomenclature (MDN):
- Devices must be classified according to the MDN system, which provides a standardized naming convention for medical devices.
6. Safety and Performance Information:
- Packaging and labeling must include information on the device's safety and performance characteristics.
7. Compliance with Japanese Standards:
- Labels and packaging must comply with Japanese standards and regulations for medical devices.
It's important for manufacturers to carefully review and comply with all applicable labeling and packaging requirements to ensure their devices can be marketed and used in Japan legally.
