Confirm that the device qualifies as Class I under ANVISA’s classification system. This is essential since different classes follow different registration pathways.

No, Class I IVD medical device registration under Hong Kong MDACS does not require annual renewal. Instead, the registration is valid for 5 years from the date of approval. After this 5-year period, a renewal application must be submitted to continue marketing and selling the device in Hong Kong.

The Class I IVD medical device registration under Hong Kong MDACS offers several significant benefits for manufacturers, distributors, and healthcare providers. These benefits include regulatory compliance, market access, product credibility, and more.

After the initial registration, the device must undergo renewal at the end of the 5-year period to continue being legally marketed and sold in Hong Kong. The renewal process typically involves submitting updated documentation and ensuring ongoing compliance with regulatory requirements.

Class I IVD medical device registration under Hong Kong MDACS refers to the process of obtaining regulatory approval to market and sell Class I In Vitro Diagnostic (IVD) medical devices in Hong Kong. MDACS stands for the Medical Device Administrative Control System, which is the regulatory framework used by the Hong Kong Department of Health (DoH) to manage medical device registration, including IVD devices.

To register and apply for Class I IVD (In Vitro Diagnostic) medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS), you need to follow a clear process.

To apply for Class I IVD (In Vitro Diagnostic) medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS), the following procedures and steps must be followed. The process ensures that medical devices comply with local regulations for safety, quality, and performance before they can be marketed and sold in Hong Kong.

Before applying, confirm that the device qualifies as a Class I IVD medical device under Hong Kong’s regulations. This class typically includes devices that are low-risk and have minimal regulatory requirements.