When the same registration application includes different packaging specifications, only one packaging specification can be checked. For the application for registration of in vitro diagnostic reagents, if the same application for registration contains products with different packaging specifications, the applicant can choose to register and inspect products with one packaging specification, and products with other packaging specifications should be reviewed and inspected in the production quality system.
This practice can reduce the cost and risk of applicants and improve the registration efficiency. However, it should be noted that just checking one packaging specification does not mean that other packaging specifications do not need to meet the requirements of relevant laws and standards. The applicant still needs to ensure the safety and effectiveness of all packaged products, and meet the relevant requirements of the "Good Manufacturing Practice for Medical Devices".
In addition, after the product goes on the market, the regulatory authorities can still take measures such as supervision and inspection and sampling inspection on other packaging specifications to ensure that they meet the requirements of relevant laws and standards. Therefore, the applicant should conscientiously perform the main responsibility to ensure the safety and effectiveness of the product and comply with relevant laws and standards.
Products to register:
1, drugs. Drugs include Chinese herbal medicines, Chinese herbal pieces, Chinese patent medicines, chemical raw materials and their preparations, antibiotics, biochemical drugs, radioactive drugs, serum, vaccines, blood products and diagnostic drugs.
2. Medical equipment. Medical devices include in vitro diagnostic reagents, as well as components and parts related to medical devices, such as instruments, equipment, appliances, materials and other articles that contact human or animal tissues.
3. Health food. Including foods that claim to have specific health care functions or are aimed at supplementing vitamins and minerals, that is, "police mobile force" health food.
4. cosmetics. There are many products that need to be registered. If you want to know more information, you can consult relevant departments or institutions.