Class I IVD (in vitro diagnostic) medical device registration in Hong Kong under the Medical Device Administrative Control System (MDACS) is a voluntary process, intended to ensure that low-risk IVD devices meet safety, quality, and performance standards. This registration is handled by the Department of Health’s Medical Device Division (MDD).

In Hong Kong, Class I IVD (In Vitro Diagnostic) medical devices are those considered to be low-risk under the Medical Device Administrative Control System (MDACS), overseen by the Department of Health’s Medical Device Division (MDD). The MDACS system provides a structured process to ensure the safety, quality, and performance of medical devices before they can be marketed.

Applying for Class I IVD (in vitro diagnostic) medical device registration in Hong Kong under the Medical Device Administrative Control System (MDACS) is relatively streamlined. Class I devices are considered low-risk, so they generally follow simpler procedures compared to higher-risk categories.

The time to obtain Class I medical device registration with ANVISA in Brazil typically takes around 1 to 3 months. However, the specific timeline can vary based on several factors, including the completeness of your application and the workload of ANVISA.

No, Class I medical device registration with ANVISA in Brazil does not require annual reviews. However, once registered, the device must be maintained in compliance with ANVISA's regulations and subject to post-market surveillance.

The Class I medical device registration with ANVISA (Brazilian Health Regulatory Agency) serves several critical purposes in the regulatory landscape of Brazil.

The time it takes to obtain Class I medical device registration with ANVISA in Brazil can vary, but typically it takes between 1 to 3 months from the submission of the application to approval. The specific timeline depends on several factors, such as the completeness of the documentation submitted and whether ANVISA requests additional information.

Class I medical device registration with ANVISA (Brazilian Health Regulatory Agency) refers to the formal process through which a medical device is approved for sale and distribution in Brazil. Class I devices are considered to be of low risk, and as such, they are subject to simpler and less stringent regulatory requirements compared to higher-risk devices (Class II and III). This process ensures that the device meets safety, efficacy, and regulatory standards set by ANVISA, allowing it to be legally marketed and used in Brazil.