On September 1, 2025, the Medical Device Division (MDD) of Hong Kong revised the Technical Reference TR-007: Software Medical Devices and Cybersecurity, and issued a Chinese version of the document.
Scope
Revision of Technical Reference TR-007 and issuance of its Chinese version.
Key Points
- Section 5.3.2: Clarifies Classification Rule 12 is applicable to software that does not direct control any hardware MDs or does not serve any medical purpose in a standalone manner.
- Section 5.4.2.2: Specifies that approvals obtained on or before December 31, 2004 refer to the marketing approvals mentioned in Guidance Note GN-02.
- Section 5.4.6.1: Updates the jurisdictions whose marketing approvals are recognized by MDACS, including:
- GHTF founding members: Australia, Canada, the European Union (EU), Japan, and the USA
- Mainland China, South Korea, and Singapore
- Also updates Mainland China’s National Standard number for Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes from YY/T 0287 to GB/T 42061.
Chinese Version Issued: A Chinese version of TR-007 is now available for reference.
References
You can access the related guidance documents here:
TR-007: 醫療器械軟件及網絡安全
TR-007: Software Medical Devices and Cybersecurity
Effective Date
Immediate effect
Implications to Client
There is no significant impact on current practices. We will continue to monitor updates under MDACS and keep you informed of any developments.
Read the Announcement
You can access the official publication here: Revision of TR-007 and Chinese Version Issued.
Next Steps
If you are preparing or submitting medical device listings in Hong Kong that include software or cybersecurity considerations, our regulatory team can assist you in interpreting TR-007 requirements.
Contact us at info@nordpacificmed.com or click the button below for more details.