The cost and time required for B-class medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong can vary based on several factors, including the complexity of the device, the completeness of the application, and the specific regulatory requirements.

Correct Classification: Ensure that the device is classified as Class B according to the Medical Device Classification Rules. This involves determining the intended use and associated risks of the device.

Confirm that your medical device is classified as Class B by reviewing the Medical Device Classification Rules. Class B devices typically include moderate-risk devices, such as certain surgical instruments, diagnostic equipment, and some implantable devices.

In Hong Kong, the Medical Device Administrative Control System (MDACS) is the framework for the regulation of medical devices, including B-class medical devices, which are considered to pose moderate risks.

If the initial application is complete and all required documentation is provided, the review process will likely proceed more smoothly.

Registration Validity: TGA registration for medical devices is valid for an indefinite period as long as the device remains compliant with regulatory requirements and there are no significant changes to the device or its manufacturing process.

Authorization to Market: Successfully obtaining TGA registration is essential for legally selling medical devices in Australia. Without this registration, manufacturers cannot distribute their products in the market.

Standard Review Time: The TGA typically aims to complete the evaluation of Class IIb medical device applications within 60 to 90 days from the date of submission. However, this timeframe can be extended based on specific circumstances.