1, the commodity inspection authorities accept the inspection. First of all, the applicant fills in the "Export Inspection Form", which is the process of filing. The materials to be provided for commodity inspection filing include: the original and photocopy of the business license, and the official seal; Original organization code, bank account, account number, contact person and contact information. Then provide relevant documents, such as foreign trade contracts, letters of credit, original factory inspection results, etc. The commodity inspection authorities shall accept the inspection of this batch of goods after reviewing that the above documents meet the requirements; If it is found that it does not meet the requirements, the applicant may be required to supplement or modify the relevant provisions.
2. Sampling. The commodity inspection authorities shall send personnel to preside over the inspection and take samples by random sampling according to different goods forms. The applicant shall provide the storage location and cooperate with the commodity inspection personnel to do the sampling work.
Step 3 check. The inspection department can use various technical means, from sensory inspection to chemical analysis and instrumental analysis, to inspect export commodities. The inspection forms include commodity inspection self-inspection, contract inspection, factory inspection and origin inspection.
4. Issue certificates. The commodity inspection authorities shall issue inspection certificates to the goods that have passed the inspection, or affix a release stamp on the "export goods declaration form".
How to record medical laboratory items?
Application procedures for clinical trials of medical devices
I. Legal basis
1. Regulations on the Supervision and Administration of Medical Devices (Order No.650th of the State Council);
2. Measures for the Administration of Registration of in vitro Diagnostic Reagents (Order No.5 of China Food and Drug Administration);
3. Announcement of China Food and Drug Administration on Relevant Matters Concerning the Declaration of Clinical Trials of Medical Devices (Announcement No.87 of China Food and Drug Administration No.2015).
Second, the bidding conditions
1. The applicant is the relevant unit or agent within the jurisdiction of Liaoning Province;
2. The applicant shall obtain the business license and organization code certificate of the enterprise;
3 clinical trial products have been registered and tested and the conclusion is qualified;
4. The clinical trial project has passed the ethical review and signed an agreement or contract with the clinical trial institution.
Third, the application materials
1. medical device clinical trial record form (see annex) in duplicate;
2. A copy of the business license of the applicant or agent;
3. A copy of the opinions of the Ethics Committee;
4. A copy of the clinical trial agreement or contract between the applicant and the clinical trial institution;
Five copies of approval documents for clinical trials of medical devices (Category III medical devices that need to be approved for clinical trials).
The above application materials shall be true, complete, clear and tidy; Print on A4 paper, make cover and catalogue, arrange them in the above order, and bind them into a book; The copy should be clear and stamped with the official seal (multiple pages should be stamped with the riding seal) to check with the original; The same item in the application materials should be filled in the same way.
Four. Procedures and time limit for handling
1. The applicant shall submit the filing materials for clinical trials of medical devices to the Medical Device Registration Office of the US Food and Drug Administration in Liaoning.
2. Review and archiving. If the clinical trial filing form is complete, the submitted materials are complete and meet the formal requirements, it shall be filed on the spot, and the filing number shall be filled in the clinical trial filing form, stamped with the special seal for filing, and the applicant shall keep one copy; Not for the record, inform the applicant and explain the reasons.
After the applicant completes the clinical trial filing, if there is any change in the start and end date of the trial project, it should inform the original filing management department within 10 working days after the change, and keep the information change record.
Verb (abbreviation of verb) charging standard
It's free.
Cosmetics filing process and cost?
Non-special-purpose cosmetics can be tested by the US Food and Drug Administration and a third-party testing organization recognized by CMA (the certificate template is as follows), and a record inspection report of domestic non-special-purpose cosmetics can be issued. Common non-special cosmetics can be detected by microbial indicators and hygienic chemical indicators. The cost of testing is around 600 yuan.
What should I pay attention to when I go to the quality supervision station to record the inspection contract?
Party A has the most things, including land use certificate, land planning and construction project planning permit, proof of funds in place, proof of payment of all risks in construction project, drawing review opinion form, fire protection review opinion form, design scheme expert argumentation opinion form and so on. Construction contract and supervision contract.
Construction unit: enterprise qualification documents (including business license, tax registration certificate, safety production license and qualification certificate), project management personnel list and qualification documents, special operation personnel list and certificates, construction organization design, special construction plan, project manager's power of attorney, emergency rescue plan, etc.
Supervision unit: enterprise qualification documents (including business license, tax registration certificate, safety production license and qualification certificate), personnel details and qualification documents of project leaders, special supervisors and supervisors, supervision planning, safety supervision implementation rules, power of attorney of chief supervision engineer, on-site supervision scheme, etc.
The importance of product filing?
1. It is convenient for enterprises to manage the implementation of standards. After filing, it is convenient for the local standardization administrative department to grasp the implementation of standards by enterprises in the region and implement effective management.
2. It is convenient for standardization administrative departments and relevant administrative departments to supervise and inspect the implementation of relevant mandatory standards by enterprises. If it is found that mandatory standards are not implemented, it is proposed to modify or improve them or order them to suspend business for execution.
3. The filing standard can be used as the arbitration basis for product quality disputes. The enterprise product standards filed by the standardization administrative department have legal effect, which enhances fairness, improves credibility and avoids the possible arbitrariness of enterprise standards. It can be used as the basis of arbitration test and is easily recognized by customers.