The time frame for applying for Class I IVD medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS) can vary depending on several factors, such as the completeness of the application, the complexity of the device, and the workload of the regulatory authority.

The process for Class I IVD medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) involves several steps, including preparing documentation, submitting applications, and maintaining compliance with local regulations.

For Class I IVD medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), manufacturers must comply with several standards and follow established procedures to ensure that the device remains in compliance with regulatory requirements and is kept up-to-date with any changes. Regular updates are essential to maintain the validity of the registration, especially in light of new regulatory changes, safety data, and product modifications.

After applying for Class I IVD (In Vitro Diagnostic) medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), manufacturers and distributors must adhere to specific rules and requirements to ensure continued compliance with local regulations. These obligations help maintain the device’s registration status and ensure it remains safe and effective for use in the market.

Before applying for Class I IVD (In Vitro Diagnostic) medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), manufacturers must ensure that they are fully prepared to meet the regulatory requirements and submit a complete application. Proper preparation is crucial for ensuring a smooth registration process and compliance with local regulations.

After obtaining Class I IVD medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS), there are several key obligations and considerations that manufacturers and distributors must be aware of to ensure continued compliance with local regulations and to maintain the device’s legal status in the market.

For Class I IVD (In Vitro Diagnostic) medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), several international standards are referenced to ensure that devices are safe, effective, and meet regulatory requirements. These standards guide the design, manufacturing, risk management, and performance of medical devices, and while they are not legally required for all Class I devices, compliance with them is highly encouraged.

For Class I IVD medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), the following technical document requirements apply. These documents are necessary to demonstrate that the device meets the safety, performance, and regulatory standards required by the Medical Device Division (MDD) of the Department of Health.