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  laser product FDA

Laser certification

1. Application Form

Application form: contains company information, product information and so on

2. Product File / Technology Specification

Product documentation / technical information: including the preparation of detailed instructions / sales manual, installation manual, maintenance manual, etc .; product assembly drawings; and product technical information, with or without laser protection measures and their working principle description.

3. Label

Label: Eligible English label, warning label with warning sign, product label, conformity certification label (eg Complies with 21 CFR 1040.10 & 1040.11), and exit mark label and so on.

4. Laser Information

Laser device information: laser generator type, medium, laser light path, laser parameters, laser device certificate / test record (if purchased from other manufacturers, need to provide the manufacturer's information, laser device parameters / Datasheet or instructions, and the Laser devices with or without FDA certification / need to provide the FDA number).

5. Calibration Report of Power Meter

Optical power meter annual measurement test certificate and report.

6. Quality Control System

Quality control documents: Mainly include internal quality control flow chart, inspection procedures, quality control specifications / such as design and control aspects of control; production line sampling table, incoming inspection single, finished product inspection, internal inspection reports (including table samples) The

7. US Agent / Importer

US agent and US importer information: including full name of contact person, telephone / fax / email, US address / zip code, company name; and U.S. agent authorization agent agreement.

Folding Edit this paragraph application process

1, importers or agents in the arrival of the goods within five to the port of entry customs declaration form;

2, food and drug administration through the following channels to obtain the supervision of food entry

The Photocopy of customs declaration form (CF 3461, CF 3461ALT, CF 7501 or its replacement)

The A copy of the commercial invoice

The Responsibility, tax and acceptance of punishment.

3. The Food and Drug Administration examines the entry declaration form of the importer to determine whether or not to carry out physical inspection, wharf inspection or souvenir inspection.

4A, decided not to do Xiangxiang inspection. Food and Drug Administration sends a letter to the US Customs and the applicant for the application. For food and drug administration, the goods are released.

4B, decided to make the following items for the Cheung Tung inspection:

The The nature of the goods;

The The priorities of the Food and Drug Administration, and the history of the commodity.

Food and Drug Administration issued a "sampling notice" to the US Customs and the importer. The goods must remain intact and wait for further notice. After sampling, the importer can move the goods to other terminals or warehouses (please contact the US Customs for details).

5, food and drug administration to obtain physical samples. Samples were sent to the Food and Drug Administration Laboratory for laboratory analysis.

6A, Food and Drug Administration confirmed the sample to meet the requirements, food and drug administration to the US customs and importers issued a "notice."

6B, Food and Drug Administration analysis found that the sample "appears to violate the FD & C Act and other related laws". Food and drug administration to US customs and importers; notice of detention and hearing ", which informs the nature of the offense and gives ten reasons for the importer to be able to receive the goods.

This hearing is the only chance for the importer to defend and / or provide evidence for the batch to be legally entered.

7A, the consignee, the actual shipper, the importer or his designated representative to respond to the "detention and hearing notice". For oral or written testimony of whether the goods can be received.

7B, the consignee, the actual shipper, the importer or his designated representative neither responded to the Notice of Detention and Hearing, nor extended the hearing period.

8A, Food and Drug Administration on whether the product can receive a hearing. This hearing is an opportunity to state the relevant business and is limited to providing relevant evidence.

8B, Food and Drug Administration issued a notice of "refusal to enter the country" to importers. This is the same person or company that has issued a "sampling notice" to it. All "Sampling Notices" and "Notice of Detention and Hearing" are sent to a "Refusal to Enter" notice.

9A, the importer provides evidence that the product meets the requirements. Provide a reliable laboratory test, in line with published samples of human food "pollutants and incomplete standards sampling results.

9B, importers proposed "to improve or take other measures to authorize (FDAFD766 form)" application. The table requires that the adulterated or mislabeled food be re-labeled or otherwise taken to meet the requirements or convert it into a non-utility item. It is necessary to propose a concrete way of satisfying the requirements of the food.

9C, Food and Drug Administration receives US Department of Customs export or destruction of the approved goods. The export or destruction of the goods listed on the "Rejected Reception Notices" is carried out under the guidance of the US Customs.

10A, Food and Drug Administration collects processed food samples to determine whether they meet the criteria.

10B, Food and Drug Administration examines the improvement procedures proposed by importers. Compensation for liquidation losses shall be made.

11A, Food and Drug Administration identified the sample "qualified". Issued to the US Customs and importers issued a "original detention, and now be released" words "release notice."

11B, Food and Drug Administration found that the sample "failed". Importers may submit "to improve or take other measures to authorize" (see 9B) to apply, otherwise, the Food and Drug Administration will issue a "refusal to receive notice" (see 8B).

11C, Food and Drug Administration approves the importer's improvement procedures. Approved application letter, waiting for the Food and Drug Administration release notice, the goods must remain as is "statement.

11D, if past experience shows that the proposed approach will not succeed, the Food and Drug Administration will reject the applicant's improvement process. The Food and Drug Administration will not consider the second and final request unless a meaningful improvement is made to ensure a considerable likelihood of success. Applicant FDA FD 766 is notified on the table.

12, the importer to complete all the improvement procedures to inform the food and drug office cargo can be checked or sampled.

13. Food and Drug Administration conducts subsequent checks and samples to determine whether it meets the terms of the revised license.

14A, Food and Drug Administration analyzed that the sample was qualified. Issued a "notice of release" to importers and US Customs. Food and Drug Administration regulatory fees are estimated in the FDA FD790 table. Copies sent to the US Customs. US Customs is responsible for collecting the total cost, including the cost of customs officers.

14B, Food and Drug Administration finds that the sample is still unqualified. Food and Drug Administration regulatory fees are estimated in the FDA FD790 table. US Customs is responsible for collecting the total cost, including the cost of customs officers.

Importers can speed up the entry of goods!

The It is legal to establish the product to be imported before the goods are shipped.

The Please consult the private laboratory for samples of food to be imported and verify the analysis of the processing plant. While these analyzes are not the final result, they may show that the plant has the ability to produce satisfactory and legitimate products.

The Before signing the shipping contract, familiar with the legal requirements of the Food and Drug Administration.

The Requests you to assist you at the Regional Office of Food and Drug Administration at the port of entry.

The Familiar with the food import procedures described in this article.

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