In November 2002, China’s State Drug Administration (SDA), which has been replaced by China’s new Food and Drug Administration, issued an official memorandum announcing new regulations related to diagnostic products. The memorandum indicated the following basic guidelines:
- Both the drug and medical device divisions of the SDA will govern rapid diagnostic products. The two divisions will implement better-defined classifications and follow more clearly defined individual responsibilities in the future.
- Until the new regulations are fully implemented, the SDA will continue to use the following criteria in the registration process of rapid diagnostic products
- If the testing method is biological, the product will be classified as a drug and will be under the responsibility of the drug division.
- If the testing method is chemical, the product will be classified as a medical device and the medical device division will be responsible for handing the product registration
- Until the new regulations are officially implemented, most diagnostic-testing products considered to be medical devices will be grouped under Class 3.
However, due to the recent SARS (Severe Acute Respiratory Syndrome) situation in China, the Ministry of Health will be categorizing diagnostic products related to infectious disease under the category of drugs. This is being done in order to enforce more rigorous regulatory procedures for drugs on these diagnostic products and to exercise greater control over products for infectious disease in China.