How much filing is required for hydrogen storage?
For hydrogen, should be in accordance with the "GB4962-1985 Hydrogen Use Safety Technical Regulations"
"5 Hydrogen Cylinders," as follows:
5.1 For production needs, must be used on-site (indoor) cylinders, the number of which shall not exceed 5 bottles, and shall comply with the The following requirements:
5.1.1 The room must be well ventilated to ensure that the maximum hydrogen content in the air does not exceed 1% (by volume) of the same below.
The top of the building or the upper part of the external wall is provided with air windows (building) or exhaust holes. Ventilation holes should be directed toward the safety zone, the number of indoor air changes per hour shall not be less than three times, the accident ventilation per hour the number of air changes shall not be less than seven times.
5.1.2 Hydrogen cylinders and containers and cylinders holding flammable, explosive, combustible substances and oxidizing gases should not be less than 8 meters apart.
5.1.3 The distance from open flames or ordinary electrical equipment should not be less than 10 meters.
5.1.4 The distance to suction air outlets such as air-conditioning units, air compressors and ventilation equipment should not be less than 20 meters.
5.1.5 and other combustible gas storage site spacing should not be less than 20 meters.
5.1.6 There is a fixed gas cylinder bracket.
5.1.7 multi-storey buildings using gas cylinders, in addition to the special needs of production, generally appropriate to be arranged on the top floor against the outside wall.
5.2 The use of gas cylinders, prohibit knocking, collision; shall not be close to the heat source; summer should be prevented from exposure to the sun.
5.3 must use a special pressure reducer; when opening, the operator should stand at the side and back of the valve opening, and move gently.
5.4 Valve or pressure reducer leakage, shall not continue to use; valve damage, it is strictly prohibited to replace the valve with pressure in the bottle.
5.5 The gas in the bottle is strictly prohibited from exhaustion, should be retained more than 0.5 kg force / cm ^ 2 residual pressure.
Does the storage tank need to be filed?
Oil storage tanks also need to be filed, the general large-scale construction sites have their own storage tanks, and you have to obtain the appropriate procedures, you into the oil channels should also be filed with some local departments, so it is reasonable and lawful, so do not be able to casually increase the storage tanks, so there is a security risk, the regulatory authorities are also checking this aspect is more stringent to use the storage tanks, be sure to go to the record,
What formalities are required to store formaldehyde?
Business license
2. Legal person ID card front and back
3. Account opening license
4. Financial statements for 1 year
5. Personnel certificate senior 4, intermediate 4
6. Proof of use of the site
7. List of medicines
8. List of equipment
9. Office location map, floor plan,
10.Warehouse location location map, floor plan
Arrange for survey specialists according to the specifics of the premises to understand the company's information!
3, customer confirmation
4, the company for the commissioner to submit for the information, contact the teacher on-site guidance or consulting guidance!
5 information application through the agency issued qualifications, mailed or delivered to the customer!
How to record prepackaged food?
Log on to the local Market Supervision Bureau, enter the online service hall for application, business license business scope of choice "food business (only the sale of pre-packaged food)", and fill in the information to be collected for the record.
For the record need to collect information: the operator's name, unified social credit code (identity card number), legal representative (person in charge), residence, place of business, storage address, storage category, storage form, business projects, types of operators, mode of operation, whether or not the network sales, whether or not the use of vending equipment for the sale of food, the legal representative (person in charge), such as the contact phone number.
Low-temperature refrigerated medical device regulations?
Article I in order to strengthen the supervision and management of medical devices, standardize the operation of medical devices, to ensure the safety and effectiveness of medical devices, according to the "Supervision and Administration of Medical Devices Regulations", the development of these measures.
The second in the Chinese people *** and the country engaged in medical equipment business activities and its supervision and management, shall comply with these measures.
The third state food and drug administration is responsible for the national supervision and management of medical device business. Food and drug supervision and management departments at or above the county level are responsible for the supervision and management of medical equipment business in the administrative region.
Superior food and drug supervision and management departments are responsible for guiding and supervising the lower food and drug supervision and management departments to carry out supervision and management of medical devices.
Article IV in accordance with the degree of risk of medical devices, medical devices business implementation of classification management.
The operation of Class I medical devices do not require licensing and filing, the operation of Class II medical devices for the record management, the operation of Class III medical devices license management.
Article V of the State Food and Drug Administration to develop quality management standards for the operation of medical devices and supervise the implementation.
Sixth, the food and drug supervision and management departments in accordance with the law and timely release of medical device business license and record information. Applicants can inquire about the progress of approval and approval results, and the public can access the results of approval.
Chapter II business license and record management
Article 7 to engage in the operation of medical devices, shall have the following conditions:
(a) with the scope of business and the scale of operation of the quality management institutions or quality management personnel, quality management personnel should have a nationally recognized relevant professional qualifications or titles;
(b) have with the (B) with the scope of business and scale of operation of the business, storage space;
(C) with the scope of business and scale of operation of the storage conditions, all entrusted to other medical device business enterprises can not set up storage;
(D) with the operation of the medical device quality management system;
(E) with the operation of the medical device Compatible with the ability of professional guidance, technical training and after-sales service, or agreed to provide technical support by the relevant organizations.
Enterprises engaged in the operation of Class III medical devices should also have a computerized information management system that meets the quality management requirements for the operation of medical devices, to ensure that the operation of the product can be traced. Encouraged to engage in the first class, the second class of medical devices business enterprises to establish a quality management of medical equipment business in line with the requirements of the computer information management system.
Article VIII engaged in the operation of Class III medical devices, the business enterprise shall apply to the municipal food and drug supervision and management department of the location of the district and submit the following information:
(a) a copy of the business license and organization code certificate;
(b) legal representative, responsible person for the enterprise, responsible person in charge of quality of the identity of the person in charge of the identification, education, or proof of professional title Copies;
(C) organization and departmental setup description;
(D) business scope, business mode description;
(E) business premises, warehouse address of the geographic location of the map, floor plan, documents proving ownership of the house or a copy of the lease agreement (with documents proving ownership of the house);
(F) business facilities, equipment directory;
(vii) business quality management system, work procedures and other documents directory;
(viii) computer information management system basic information and functional description;
(ix) proof of authorization by the operator;
(x) other supporting materials.
Article IX for the applicant to apply for a Class III medical device license, the municipal food and drug supervision and management department shall be dealt with according to the following:
(a) the application is within the scope of its competence, the application information is complete, in accordance with the statutory form, the application shall be accepted;
(b) the application information is incomplete or does not meet the statutory form, the application shall be processed on the spot or at the same time, or in the form of the application, the application shall be accepted. (b) the application information is incomplete or does not meet the statutory form, the applicant shall be informed on the spot or within five working days of all the contents of the need to make corrections, and if not informed after the deadline, the application shall be accepted from the date of receipt of the application information;
(c) the application information can be corrected on the spot, the applicant shall be allowed to make corrections on the spot;
(d) the application does not fall within the purview of the department, it shall make a decision of non-admissibility and inform the applicant of the decision to notify the applicant. Acceptance of the decision, and inform the applicant to the relevant administrative departments.
Settlement of municipal food and drug supervision and management department acceptance or inadmissibility of the application for a medical device license, shall issue a notice of acceptance or inadmissibility.
Article 10 of the municipal food and drug supervision and management departments should be accepted within 30 working days from the date of application for review, and in accordance with the requirements of the quality management standard for the operation of medical devices to carry out on-site verification. The need for rectification, rectification time is not counted in the audit time limit.
Meet the prescribed conditions, according to law to make a written decision to grant permission, and within 10 working days to the "medical device license"; does not meet the prescribed conditions, make a written decision not to permit, and explain the reasons.
Article XI of the medical device license application directly involves the applicant and others with significant interests, the food and drug supervision and management department shall inform the applicant, the interested party in accordance with the laws, regulations and the relevant provisions of the State Food and Drug Administration to enjoy the right to apply for a hearing; in the review of medical device licensing, food and drug supervision and management that involves public **** interests of significant licenses. Public **** interests of major licensing matters, shall be announced to the community, and hold hearings.
Article XII engaged in the second class of medical equipment business, the business enterprise shall be located in the municipal food and drug supervision and management department for the record, fill in the second class of medical equipment business filing form, and submit the information provided for in Article 8 of these measures (except for the eighth).
Article XIII of the food and drug supervision and management departments shall be on the spot on the completeness of the information submitted by the enterprise to check, in line with the provisions of the record to be filed, issued by the second class of medical equipment business filing vouchers.
Article XIV of the municipal food and drug supervision and management department shall, within three months from the date of the filing of medical device business enterprises, in accordance with the requirements of the quality management standard for the operation of medical devices to carry out on-site verification of the second class of medical equipment business enterprises.
Article XV of the "Medical Device Business License" is valid for five years, set forth the license number, enterprise name, legal representative, responsible person, residence, place of business, mode of operation, scope of business, warehouse address, licensing department, date of issuance and expiration date of the validity of the license and other matters.
Medical device business record certificate shall contain the number, enterprise name, legal representative, responsible person, residence, place of business, mode of operation, business scope, depot address, filing department, filing date and other matters.
Article XVI of the "Medical Device License" matters of change is divided into licensing changes and changes in registration matters.
License changes include business premises, business mode, business scope, depot address changes.
Registration changes refer to changes in matters other than the above.
Article XVII of the licensing matters change, should be made to the original licensing department, "Medical Device License" to change the application, and submit the provisions of Article 8 of these measures involves changes in the content of the relevant information.
Trans-administrative region to set up warehouses, should be to the warehouse where the municipal food and drug supervision and management department for the record.
The original licensing department shall receive the application for change within 15 working days from the date of review, and make a decision to grant changes or not change; need to carry out on-site verification in accordance with the requirements of the Code of Practice for the Management of Quality of Medical Devices, from the date of receipt of the application for change 30 working days from the date of change to make a decision to grant changes or not change. Do not change, should be written and inform the applicant of the reasons. After the change of "medical device license" number and validity of the same.
Article XVIII of the newly established independent business premises, should apply for a separate medical device license or record.
Article 19 of the change in registration matters, medical equipment business enterprises should be timely to the municipal food and drug supervision and management department for change procedures.
Article 20 due to separation, merger and survival of the medical device business enterprises, shall apply for change of license in accordance with the provisions of these measures; due to separation, merger and dissolution of enterprises, shall apply for cancellation of the "medical device license"; due to separation, merger and the establishment of a new enterprise, shall apply for the "medical device license".
Article 21 of the medical device registrant, filer or manufacturer of medical devices in its residence or production address sales of medical devices, do not need to apply for a license or record; in other places of storage and spot sales of medical devices, shall be in accordance with the provisions of the business license or record.
Article 22 of the "Medical Device License" expiration of the need to continue, the medical device business enterprises should be expired six months before the expiration date, to the original licensing department for the "Medical Device License" renewal application.
The original licensing department shall be in accordance with the provisions of Article 10 of the continuation of the application for review, on-site verification, if necessary, in the "medical device license" before the expiration of the validity of the decision on whether to grant the continuation. Meet the prescribed conditions, granted the continuation of the continuation of the "medical device license" number unchanged. Does not meet the prescribed conditions, ordered to rectify; rectification still does not meet the prescribed conditions, not to continue, and a written explanation of the reasons. Late decision is not made, deemed to be granted the continuation.
Article 23 of the medical device business filing certificate in the business name, legal representative, responsible person, residence, place of business, mode of operation, scope of business, depot address and other filing changes should be changed in a timely manner for the record.
Article 24 of the "medical device license" lost, medical equipment business enterprises should immediately in the original licensing department designated media published a statement of loss. Since the date of publication of the statement of loss of 1 month after the date, to the original licensing department to apply for reissue. The original licensing department in a timely manner to reissue the "medical device license".
Replacement of the "Medical Device License" number and validity period with the original license.
Article 25 of the medical device business record certificate is lost, the medical device business enterprises should be timely to the original record department for reissue procedures.
Article 26 of the medical equipment business enterprises due to illegal operation of the food and drug supervision and management department to investigate but not yet concluded, or received an administrative penalty decision but has not yet been fulfilled, the municipal food and drug supervision and management department shall suspend the license until the case is completed.
Article 27 of the medical device business enterprises have laws and regulations should be written off, or the validity period has not expired, but the company took the initiative to cancel, the municipal food and drug supervision and management departments should be written off according to law, "Medical Device License", and be published on the website.
Article 28 of the municipal food and drug supervision and management department shall establish the "medical device license" issued, continuation, change, reissue, revocation, cancellation and other licensing files and medical device business filing information files.
Article 29 No unit or individual shall not forge, alter, buy, sell, lease, lend "medical device license" and medical device business filing vouchers.