News-Zhongbang Registration Compliance

How to deal with the expiration of the authorization letter of the domestic responsible person for new raw materials?
A
According to the provisions of Article 11 of the Provisions on the Management of Registration and Filing Data of New Raw Materials for Cosmetics, after the authorization period specified in the authorization letter of the domestic responsible person expires, the authorization letter for extending the authorization period shall be resubmitted within 30
Cosmetic China cosmetics
Jul. 24th, 2023
Need to recall Class I reusable devices to re-label them?
A
No, you do not need to withdraw those devices that were placed on the market before May 26, 2020 under the MDD regime. This also includes reusable Class I devices. In general, medical devices legally placed on the market under the current MDD/AIMDD prior to May 25, 2020, may be supplied and placed into service until May 25, 2025.
Medical Devices
Jul. 21th, 2023
What are the main changes in the new MDR?
Some major changes include: 1. Expansion of product range. The definition of medical devices and active implantable medical devices will be greatly expanded to include devices that do not have a medical purpose and devices designed to predict "disease or other health conditions."
Medical Devices
Jul. 21th, 2023
When will medical device manufacturers need to comply with the new MDR?
A
Manufacturers of currently approved medical devices will have a three-year transition period (until May 26, 2020) to meet the requirements of the MDR. For certain devices, this transition period can be extended until May 26, 2024. However, special requirements must be met to grant this extension.
Medical Devices
Jul. 21th, 2023
CE certification for which countries or regions?
CE certification is the European Union product certification, applicable to the European region. Due to the high visibility of CE certification, in fact, in some countries and regions where the certification requirements are not high, such as Africa, the Middle East, Southeast Asia, South America and other countries, sometimes CE certification can be a
CE
Jul. 21th, 2023
Is there a certificate of FDA registration?
A
In fact, there is no certificate for FDA registration, the product will be registered with the FDA, will receive a registration number, FDA will send the applicant a letter (signed by the FDA administrator), but there is no FDA certificate. The certificate we usually see is issued to the manufacturer by the intermediary agent (Registration agent) to pr
Food FDA
Jul. 21th, 2023
Is FDA registration different from CE certification?
A
The model of his certification is different from the CE certification of product testing + report certificate model, the FDA registration actually uses the integrity declaration model, that is, you are responsible for your own products meet the relevant standards and safety requirements, and register on the federal website in the United States, if the
Medical Devices FDA
Jul. 21th, 2023
Does FDA registration necessarily require a U.S. agent
A
Yes, a business must appoint a U.S. citizen (company/association) as its agent when registering with the FDA. This agent is responsible for conducting the process services located in the United States and is the medium for contacting the FDA and the applicant.
Jul. 21th, 2023
Does the FDA require designated certified laboratory testing?
A
The FDA is an enforcement agency, not a service agency. If someone says they are a certified laboratory under the FDA, then he is misleading consumers at the very least, because the FDA does not have a public service certification body and laboratory, nor does it have a so-called "designated laboratory."
Jul. 21th, 2023
Which agency issues FDA certificates?
A
FDA certification is issued directly by the U.S. Food and Drug Administration (FDA). The FDA is an agency of the U.S. federal government responsible for regulating the safety and effectiveness of food, drugs, medical devices, and other products, including approving the marketing of new products and monitoring the quality and safety of products already
Jul. 21th, 2023

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