When the same registration application includes different packaging specifications, only one packaging specification product can be inspected.
When the same registration application includes different packaging specifications, only one packaging specification product can be inspected. For in vitro diagnostic reagent registration applications, if the same registration application contains products with different packaging specifications, the applicant can choose to conduct registration inspection on one packaging specification product, while other packaging specifications products should be reviewed and inspected in the production quality system.
This approach can reduce costs and risks for applicants and improve registration efficiency. However, it should be noted that only conducting product inspection of one packaging specification does not mean that other packaging specifications do not need to comply with relevant regulations and standards. Applicants still need to ensure the safety and effectiveness of products in all packaging specifications and comply with the relevant requirements of Good Manufacturing Practice for Medical Devices.
In addition, after the product is on the market, regulatory authorities can still conduct supervisory inspections and sampling inspections on other packaging specifications to ensure that they comply with relevant regulations and standards. Therefore, applicants should conscientiously fulfill their main responsibilities, ensure the safety and effectiveness of products, and comply with relevant regulations and standards.
Products that require registration:
1. Drugs. Drugs include Chinese medicinal materials, 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, utensils, materials and other items that come into contact with human or animal tissue.
3. Health food. Including foods that claim to have specific health functions or are for the purpose of supplementing vitamins and minerals, that is, "blue hat" health foods.
4. Cosmetics. There are many products that need to be registered. If you want to know more information, you can consult the relevant departments or institutions.