Interpretation | New Policy of Customs Export Medical Materials Supervision
- Author:sofreight.com
- Source:sofreight.com
- Release Date:2024-03-22
Recently, the General Administration of Customs has continuously issued a new policy of export medical supplies supervision, which has aroused strong attention from all walks of life.We will take you to understand the relevant policies.
Background interpretation
(1) The State Drug Supervision and Administration Bureau of the General Administration of Customs of the Ministry of Commerce No. 5, No. 5, 2020 "Announcement on the Export of Medical Materials" (hereinafter referred to as "Announcement" No. 5))
From April 1st, when the new coronary virus test agent, medical mask, medical protective clothing, ventilator, and infrared thermometer are required to provide a written or electronic statement when they declare to the customs.Certificate meets the quality standard requirements of importing countries (regions).The Customs is approved by the medical device product registration certificate approved by the drug supervision and management department.
The above five medical supplies belong to the medical device management of the "Catalog of Medical Device". The specific categories are as follows:
Interpretation | New Policy of Customs Export Medical Materials Supervision
(2) Announcement of the General Administration of Customs 2020 (hereinafter referred to as "Announcement No. 53")
From April 10, the inspection of export commodities under the 11 types of medical materials under the customs number of "6307900010" has involved 19 HS codes.
Interpretation | New Policy of Customs Export Medical Materials Supervision
It should be noted that among the 11 categories of medical supplies in the "Announcement of No. 53", 4 of the 5 categories of "Announcement No. 5" in the "Announcement of Announcement 5" ("Announcement of No. 5", test reagents have previously implemented health quarantine approval approvalTo.
Legal basis
"Inspection Law of the People's Republic of China Import and Export Commodity"
Article 5 The import and export products included in the directory shall be inspected by the commodity inspection agency.
If the imported goods stipulated in the preceding paragraph are not allowed to be sold or used; if the export products specified in the preceding paragraph have not passed the inspection, they are not allowed to be exported.
Article 15 The provisions of this Law must be inspected by the commodity inspection agency within the place and period stipulated by the commercial inspection agency.Commodity inspection agencies shall be inspected within the time limit prescribed by the national commodity inspection department and issue a verification form.
Article 33 In violation of the provisions of this Law, if the imported goods inspected by the commercial inspection institution will be sold or used without authorization, or the export goods that must be inspected by the commercial inspection agency will be exported without the inspection of the inspection.A fine of illegal income from the commodity inspection agency and the amount of less than 20%or less than 5%or less; if a crime constitutes a crime, criminal liability is investigated in accordance with the law.
Article 35 If imports or exports belong to adulteration, fake and authenticity, useful products or unqualified imports and exports to pretend to be qualified imports and exports, the commodity inspection agency is orderedAnd fines of less than 50 % of the value of the goods; if a crime is constituted, criminal liability is investigated in accordance with the law.
The Implementation Regulations of the People's Republic of China Import and Export Commodity Inspection Law
Article 24 The travelers of the exported commodities in statutory inspection shall notice the necessary vouchers such as contracts and relevant approval documents within the place and period of the place where the General Administration of Customs will be uniformly stipulated.If the legal inspection of export goods is not inspected or unqualified, it is not allowed to export.
Export products should be inspected in the production site of the goods.The General Administration of Customs can be inspected in other locations according to the needs of convenient foreign trade and import and export commodities.
Exports are implemented by verification management, and the shipper shall apply to the entry and exit inspection and quarantine agency for verification.Entry -exit inspection and quarantine agencies shall be verified in accordance with the regulations of the General Administration of Customs.
Article 44 Export products that have not been checked or have not been tested without inspection, or exported products that shall apply for export verification without authorization, shall confiscate illegal income from the entry -exit inspection and quarantine agency and be in the commodity.The value of the value of less than 5%and less than 20%; if a crime is constituted, criminal liability is investigated in accordance with the law.
policy analyzing
The key points!
1. Customs adopt a verification management method for the 11 category of export legal inspection medical supplies stipulated in the "Announcement of No. 53".
2. Among the 19 HS encoding products involved in the "Announcement of No. 53", the medical inspection needs to be implemented.For medical supplies, the customs supervision is determined according to the characteristics of the product itself rather than the application purposes.
For details of judging standards, please refer
Link:
http://sjs.customs.gov.cn/sjs/zcfg56/2963129/index.html?from=groupmessage
Customs latest regulatory measures
1. Strengthen the document review
The "Announcement of No. 53" is the supervision measure of customs for medical supplies and does not involve non -medical supplies. Therefore, the reporting system has not set up export commodity inspection and supervision conditions in 19 HS coding goods in Announcement 53.Customs adopt an electronic review and artificial review method to handle the declaration document involved in the "Announcement of No. 53".
(1) 5 medical supplies listed in the "Announcement 5" (including the follow -up adjustment of the announcement), when the enterprise declares the customs declaration to the customs, it must provide a written or electronic quality and safety commitment statement and the registered certificate of medical device products in my country.The new coronal virus testing agent must also provide export sales certificates issued by the drug supervision department.
(2) For 7 categories of medical supplies other than "Announcement 53" listed in the "Announcement of Announcement 53", when companies declare to customs, they should provide medical device product registration (category III/II medical devices)/filing (Class I medical treatmentDevice) Prove and quality and safety commitment statement.Those who have no relevant proof and commitment statement will implement strict supervision.
(3) For the new crown virus testing agent, the trader shall also apply for the examination and approval of sanitary quarantine.Fill in the electronic account account.
(4) For medical supplies for exporting legal inspections, it is recommended that enterprises fill in the application of the name column of the customs declaration order, and indicate whether to do medical, and test the reagent to indicate whether it is a new coronary virus test.
The customs will strictly review the registration certificate of the medical device product and the enterprise quality and safety commitment, and focus on whether there is a situation of lack of lack, use, and pseudo -medical device product registration certificate, and whether the certification number is consistent with the website of the State Drug Administration.
2. Strict on -site inspection
The customs inspection department of the customs shall implement inspections based on the control instructions, thorough inspection of the discovery of abnormalities, and samples to send qualified laboratory inspections if necessary.
The export legal inspection medical supplies shall meet the requirements of importing countries (regions). If there is no quality and safety standard for importing countries (regions), it shall meet my country's quality and safety standards.
For details, please refer to: some countries (regions) technical regulations and standards and standard requirements (third edition)
Link:
http://sjs.customs.gov.cn/sjs/zcfg56/2951967/index.html
3. Strict cracking down on illegal and violations
Customs implement rapid disposal of export -proof materials for export of quality and safety issues in accordance with laws and regulations; for pseudo -reporting of export -related epidemic prevention supplies, clipplanes, adulteration, false charges, secondary charges, or impersonation with unqualified or unqualified impersonation.Those who have illegal acts such as qualifications shall be severely investigated and punished in accordance with laws and regulations; if they are suspected of crimes, they will be transferred to local public security organs to investigate criminal responsibility.
The illegal situation of the enterprise will be included in the corporate credit records and will be used as an important basis for customs risk management and credit management; the customs shares relevant information to the national credit information sharing platform, and the relevant departments shall jointly disciplinary disciplinary on the customs of customs.
Questions that the company cares about
Question: In the early stage of the epidemic, due to the low yield of medical epidemic prevention materials such as domestic masks, the demand for epidemic prevention could not meet the demand for epidemic prevention. Some enterprises responded to the country's call and urgently purchased epidemic prevention materials such as masks such as masks.Related enterprises have been put into operation and produced a large number of medical epidemic prevention materials such as masks, which contribute to the successful resistance.
If the enterprise that has obtained emergency registration certificates of medical device during the epidemic situation has not been exported normally within the corporate list published by the website of the State Drug Administration?
Customs: Customs conducts verification in accordance with the corporate list released by the State Drug Administration when conducting documents.It is understood that through rapid approval procedures, some provinces have maintained the company's list of enterprises published by emergency/temporary registered certificates in the early stage, and related companies can export them.Related details Enterprises can consult the local drug supervision and management department.
Q: How can companies and individuals judge medical/non -medical based on the characteristics of the product itself?
Customs: Different use of epidemic prevention products have different technical requirements and scope of applicable.The first is to distinguish the appearance and packaging information.The smallest unit packaging of epidemic prevention products sold in formal channels should have information such as product names, standards and protection grades of execution. The information that these merchants explicitly show can be used as a distinguished point.
Taking masks as an example, such as "medical" or "Surgical" and "Medical" in English in the name of the product, can generally be judged as a medical mask; the second is to distinguish it according to the applicable standards.Medical/non -medical products apply different standards and certification requirements. Enterprises and individuals can judge according to the application standards and certification information provided by the product provided by the product or the product provided by the product or the product provided by the producer.
Question: How can a medical disinfectant be inspected for export commodities if it belongs to dangerous chemicals?
Customs: If it is a hazardous chemical product, it shall implement the inspection of the origin according to the original requirements (if it is a dangerous cargo, it is necessary to implement the inspection and appraisal of the dangerous goods packaging), and the port inspection is implemented in accordance with the requirements of the "Announcement of No. 53".
Background interpretation
(1) The State Drug Supervision and Administration Bureau of the General Administration of Customs of the Ministry of Commerce No. 5, No. 5, 2020 "Announcement on the Export of Medical Materials" (hereinafter referred to as "Announcement" No. 5))
From April 1st, when the new coronary virus test agent, medical mask, medical protective clothing, ventilator, and infrared thermometer are required to provide a written or electronic statement when they declare to the customs.Certificate meets the quality standard requirements of importing countries (regions).The Customs is approved by the medical device product registration certificate approved by the drug supervision and management department.
The above five medical supplies belong to the medical device management of the "Catalog of Medical Device". The specific categories are as follows:
Interpretation | New Policy of Customs Export Medical Materials Supervision
(2) Announcement of the General Administration of Customs 2020 (hereinafter referred to as "Announcement No. 53")
From April 10, the inspection of export commodities under the 11 types of medical materials under the customs number of "6307900010" has involved 19 HS codes.
Interpretation | New Policy of Customs Export Medical Materials Supervision
It should be noted that among the 11 categories of medical supplies in the "Announcement of No. 53", 4 of the 5 categories of "Announcement No. 5" in the "Announcement of Announcement 5" ("Announcement of No. 5", test reagents have previously implemented health quarantine approval approvalTo.
Legal basis
"Inspection Law of the People's Republic of China Import and Export Commodity"
Article 5 The import and export products included in the directory shall be inspected by the commodity inspection agency.
If the imported goods stipulated in the preceding paragraph are not allowed to be sold or used; if the export products specified in the preceding paragraph have not passed the inspection, they are not allowed to be exported.
Article 15 The provisions of this Law must be inspected by the commodity inspection agency within the place and period stipulated by the commercial inspection agency.Commodity inspection agencies shall be inspected within the time limit prescribed by the national commodity inspection department and issue a verification form.
Article 33 In violation of the provisions of this Law, if the imported goods inspected by the commercial inspection institution will be sold or used without authorization, or the export goods that must be inspected by the commercial inspection agency will be exported without the inspection of the inspection.A fine of illegal income from the commodity inspection agency and the amount of less than 20%or less than 5%or less; if a crime constitutes a crime, criminal liability is investigated in accordance with the law.
Article 35 If imports or exports belong to adulteration, fake and authenticity, useful products or unqualified imports and exports to pretend to be qualified imports and exports, the commodity inspection agency is orderedAnd fines of less than 50 % of the value of the goods; if a crime is constituted, criminal liability is investigated in accordance with the law.
The Implementation Regulations of the People's Republic of China Import and Export Commodity Inspection Law
Article 24 The travelers of the exported commodities in statutory inspection shall notice the necessary vouchers such as contracts and relevant approval documents within the place and period of the place where the General Administration of Customs will be uniformly stipulated.If the legal inspection of export goods is not inspected or unqualified, it is not allowed to export.
Export products should be inspected in the production site of the goods.The General Administration of Customs can be inspected in other locations according to the needs of convenient foreign trade and import and export commodities.
Exports are implemented by verification management, and the shipper shall apply to the entry and exit inspection and quarantine agency for verification.Entry -exit inspection and quarantine agencies shall be verified in accordance with the regulations of the General Administration of Customs.
Article 44 Export products that have not been checked or have not been tested without inspection, or exported products that shall apply for export verification without authorization, shall confiscate illegal income from the entry -exit inspection and quarantine agency and be in the commodity.The value of the value of less than 5%and less than 20%; if a crime is constituted, criminal liability is investigated in accordance with the law.
policy analyzing
The key points!
1. Customs adopt a verification management method for the 11 category of export legal inspection medical supplies stipulated in the "Announcement of No. 53".
2. Among the 19 HS encoding products involved in the "Announcement of No. 53", the medical inspection needs to be implemented.For medical supplies, the customs supervision is determined according to the characteristics of the product itself rather than the application purposes.
For details of judging standards, please refer
Link:
http://sjs.customs.gov.cn/sjs/zcfg56/2963129/index.html?from=groupmessage
Customs latest regulatory measures
1. Strengthen the document review
The "Announcement of No. 53" is the supervision measure of customs for medical supplies and does not involve non -medical supplies. Therefore, the reporting system has not set up export commodity inspection and supervision conditions in 19 HS coding goods in Announcement 53.Customs adopt an electronic review and artificial review method to handle the declaration document involved in the "Announcement of No. 53".
(1) 5 medical supplies listed in the "Announcement 5" (including the follow -up adjustment of the announcement), when the enterprise declares the customs declaration to the customs, it must provide a written or electronic quality and safety commitment statement and the registered certificate of medical device products in my country.The new coronal virus testing agent must also provide export sales certificates issued by the drug supervision department.
(2) For 7 categories of medical supplies other than "Announcement 53" listed in the "Announcement of Announcement 53", when companies declare to customs, they should provide medical device product registration (category III/II medical devices)/filing (Class I medical treatmentDevice) Prove and quality and safety commitment statement.Those who have no relevant proof and commitment statement will implement strict supervision.
(3) For the new crown virus testing agent, the trader shall also apply for the examination and approval of sanitary quarantine.Fill in the electronic account account.
(4) For medical supplies for exporting legal inspections, it is recommended that enterprises fill in the application of the name column of the customs declaration order, and indicate whether to do medical, and test the reagent to indicate whether it is a new coronary virus test.
The customs will strictly review the registration certificate of the medical device product and the enterprise quality and safety commitment, and focus on whether there is a situation of lack of lack, use, and pseudo -medical device product registration certificate, and whether the certification number is consistent with the website of the State Drug Administration.
2. Strict on -site inspection
The customs inspection department of the customs shall implement inspections based on the control instructions, thorough inspection of the discovery of abnormalities, and samples to send qualified laboratory inspections if necessary.
The export legal inspection medical supplies shall meet the requirements of importing countries (regions). If there is no quality and safety standard for importing countries (regions), it shall meet my country's quality and safety standards.
For details, please refer to: some countries (regions) technical regulations and standards and standard requirements (third edition)
Link:
http://sjs.customs.gov.cn/sjs/zcfg56/2951967/index.html
3. Strict cracking down on illegal and violations
Customs implement rapid disposal of export -proof materials for export of quality and safety issues in accordance with laws and regulations; for pseudo -reporting of export -related epidemic prevention supplies, clipplanes, adulteration, false charges, secondary charges, or impersonation with unqualified or unqualified impersonation.Those who have illegal acts such as qualifications shall be severely investigated and punished in accordance with laws and regulations; if they are suspected of crimes, they will be transferred to local public security organs to investigate criminal responsibility.
The illegal situation of the enterprise will be included in the corporate credit records and will be used as an important basis for customs risk management and credit management; the customs shares relevant information to the national credit information sharing platform, and the relevant departments shall jointly disciplinary disciplinary on the customs of customs.
Questions that the company cares about
Question: In the early stage of the epidemic, due to the low yield of medical epidemic prevention materials such as domestic masks, the demand for epidemic prevention could not meet the demand for epidemic prevention. Some enterprises responded to the country's call and urgently purchased epidemic prevention materials such as masks such as masks.Related enterprises have been put into operation and produced a large number of medical epidemic prevention materials such as masks, which contribute to the successful resistance.
If the enterprise that has obtained emergency registration certificates of medical device during the epidemic situation has not been exported normally within the corporate list published by the website of the State Drug Administration?
Customs: Customs conducts verification in accordance with the corporate list released by the State Drug Administration when conducting documents.It is understood that through rapid approval procedures, some provinces have maintained the company's list of enterprises published by emergency/temporary registered certificates in the early stage, and related companies can export them.Related details Enterprises can consult the local drug supervision and management department.
Q: How can companies and individuals judge medical/non -medical based on the characteristics of the product itself?
Customs: Different use of epidemic prevention products have different technical requirements and scope of applicable.The first is to distinguish the appearance and packaging information.The smallest unit packaging of epidemic prevention products sold in formal channels should have information such as product names, standards and protection grades of execution. The information that these merchants explicitly show can be used as a distinguished point.
Taking masks as an example, such as "medical" or "Surgical" and "Medical" in English in the name of the product, can generally be judged as a medical mask; the second is to distinguish it according to the applicable standards.Medical/non -medical products apply different standards and certification requirements. Enterprises and individuals can judge according to the application standards and certification information provided by the product provided by the product or the product provided by the product or the product provided by the producer.
Question: How can a medical disinfectant be inspected for export commodities if it belongs to dangerous chemicals?
Customs: If it is a hazardous chemical product, it shall implement the inspection of the origin according to the original requirements (if it is a dangerous cargo, it is necessary to implement the inspection and appraisal of the dangerous goods packaging), and the port inspection is implemented in accordance with the requirements of the "Announcement of No. 53".