Hong Kong Medical Device Classification

The Hong Kong classification system is based on GHTF document GHTF/SG1-N15:2006 and are in accordance with the requirements of the Medical Device Administrative Control System (MDACS). Risk can be dependent on the intended use, effectiveness of risk management during the design and manufacturing process, degree of invasiveness, delivery method, duration of contact, intended users, and technologies.

Products are classified into one of the following, from lowest to highest risk:

• Class I
• Class II
• Class III
• Class IV

Hong Kong’s Medical Device Control Office (MDCO) has an online tool to help determine MD classification.

As risk increases, more documentation may be required. Contact Asia Actual for more details.

IVD Classification

IVD products are also classified into one of the following, from lowest to highest risk:

• Class A
• Class B
• Class C
• Class D

Risk is determined by intended use, the expertise of the intended user, the importance of the resulting information of the diagnostic, and the impact of the test results. For example, an HIV Tests are Class D.

Hong Kong’s Medical Device Control Office (MDCO) has an online tool to help determine IVD classification.

Software Classification

If stand-alone software can be defined as a medical device, then it will be classified depending on the following:

• If it influences the use of another medical device, then the classification will be determined by the intended use of the combined products
• If it is independent from any medical device, then it will be classified according to the Hong Kong classification rules
• Stand-alone software is considered an active device and this can also affect its classification

Contact Asia Actual for more information about the Hong Kong classification system.