FAQ-Zhongbang Registration Compliance

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
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
Is there a certificate after EU REACH registration
A
No, registration is the main obligation under REACH. After a successful submission of a registration dossier for a chemical substance to the European Chemicals Management Agency (ECHA), a company will receive an 18-digit registration number. Enterprises that fail to complete the registration before the corresponding deadline will not be able to continu
EU REACH
Jul. 21th, 2023
How to determine reporting boundaries? If the reporting organization is a branch or factory level organization, should other branches or factories be included?
A
CDP and its customers expect to see emissions data and environmental management details for the full range of the invited companies (all production sites or subsidiaries). If data and information on the activities of all sites or branches can be collected, the emissions can be aggregated and filled out in the online questionnaire (e.g., Scope 1 and Sco
CDP
Jul. 20th, 2023
What data do companies need to collect for greenhouse gas accounting?
A
Starting with the delineation of equipment related to greenhouse gas emissions, the equipment may be directly controlled/owned by the company and used in the production process (scope 1), or it may be equipment that uses outsourced electricity, heat, etc. (Scope 2). The most common greenhouse gases are 1) fossil fuels (coal, natural gas, gasoline and d
CDP
Jul. 20th, 2023
If a company has multiple department/subsidiary filers filing together, how can the respective answers be integrated?
A
Note that an organization that is invited to fill out and submit a questionnaire is required, and all respondents from different departments or branches are required to integrate the responses - such as greenhouse gas emissions, etc. - into the questionnaire. In the process of collecting data and information of various departments/branches, offline que
CDP
Jul. 20th, 2023

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