General Order No. 95, "Import Inspection Supervision and Administration of Medical Devices" 2007.6.8

"Supervision and management of inspection of imported medical devices" has been May 30, 2007 General Administration of Quality Supervision, Inspection and Quarantine Bureau of Finance meeting, is hereby promulgated, December 1, 2007 shall come into force.

Secretary June 18, 2007

Import Inspection Supervision and Administration of Medical Devices

Chapter I General Provisions

In order to strengthen inspection and supervision of imported medical devices, to protect human health and safety, according to "Import and Export Commodity Inspection Law" (hereinafter referred to as the Commodity Inspection Law) and its implementing regulations and other relevant laws and regulations, formulated.

Second approach applies to:

(A) the importer of medical devices classified management;

(B) the import of medical devices for the inspection and supervision;

(C) the import of medical devices for the implementation of risk management early warning and rapid response.

Article of Quality Supervision, Inspection and Quarantine (hereinafter referred to as AQSIQ) shall be in charge of imported medical devices inspection supervision, is responsible for the organization collected and imported medical equipment-related risk information, risk assessment and take the risk early warning and rapid response measures.

AQSIQ in the entry-exit inspection and quarantine agencies around (hereinafter referred to as inspection and quarantine institutions) is responsible for inspection of imported medical devices under the jurisdiction of district supervision and management, responsible for collecting and imported medical equipment information and the risks associated with specific measures to implement rapid response .

Chapter II medical device regulatory classification of imported units

Article inspection and quarantine agencies in accordance with the management of medical equipment import unit level, integrity, imports of medical equipment products level of risk, quality status and the scale of imports of medical equipment imported units in a classification regulation, specifically divided into three categories.

Medical equipment imported under the conditions of voluntary units can be classified management application.

Article a class of import shall meet the following conditions:

(A) strictly abide by the Commodity Inspection Act and its implementing regulations, other relevant state laws and regulations and the relevant provisions of the AQSIQ, high integrity, no bad record for five consecutive years;

(B) has a sound quality management system, obtained ISO9000 quality system certification, with a sound quality management system, including import inspection, purchase inspection, storage, quality tracking and defect reporting system;

(C) the inspection and quarantine institution has two or more quality training of qualified personnel, familiar with the basic technology-related products, performance and structure, to understand China's inspection and supervision on imported medical equipment management;

(D) agent or management system of mandatory product certification of imported medical products, should receive the appropriate documents;

(E) agency or the import business of medical device product quality reputation and two years did not occur due to product quality and responsibility in the return, claim or other accidents;

(F) continuously engaged in the import of medical equipment less than 6 years, and can provide the appropriate documents;

(G) in the last two years not less than 30 batches each batch of imports;

(H) collect and maintain national standards for medical devices, medical devices industry standards and the laws and regulations and special provisions, the establishment and preservation of more complete data files of imported medical devices, retention period of not less than 10 years;

(I) have its products imported medical devices suited to technical training and service capabilities, or by a third party agreed to provide technical support;

(X) and imports of medical products with the scope and scale to adapt to, relatively independent of the premises and storage conditions.

Article II importing unit shall meet the following conditions:

(A) strictly abide by the Commodity Inspection Act and its implementing regulations, other relevant state laws and regulations and the relevant provisions of the AQSIQ, high integrity, no bad record for three consecutive years;

(B) has a sound quality management system, with a sound quality management system, including import inspection, purchase inspection, storage, quality tracking and defect reporting system;

(C) the inspection and quarantine institution with a more trained and qualified quality management staff, familiar with the basic technology-related products, performance and structure, to understand China's inspection and supervision on imported medical equipment management personnel;

(D) agency or business the mandatory product certification system, the import of medical products, should receive the appropriate documents;

(E) agency or the import business of medical device product quality reputation and 1 year did not occur due to product quality and responsibility in the return, claim or other accidents;

(F) continuously engaged in the import of medical equipment not less than three years, and can provide the appropriate documents;

(G) in the last two years not less than 10 batches of each batch of imports;

(H) collect and maintain national standards for medical devices, medical devices industry standards and the laws and regulations and special provisions, the establishment and preservation of more complete data files of imported medical devices, retention period of not less than 10 years;

(I) have its products imported medical devices suited to technical training and service capabilities, or by a third party agreed to provide technical support;

(X) and imports of medical products with the scope and scale to adapt to, relatively independent of the premises.

Article three imported units include:

(A) engaged in the import of medical equipment import business units under 3 years;

(B) engaged in the import medical equipment business is full three years, but did not make application for import of category management unit;

(C) The classification application, the assessment does not meet the first and second units of the import conditions are not included in the first and second category management, the import unit.

Article 8 The application of a class imported unit or units of two types of imports of imports of medical equipment (hereinafter referred to as the applicant) shall apply to the location directly under the Inspection and Quarantine Bureau, and submit the following materials:

(A) a written application and an authorized signature and Seal;

(B) the business license, Medical Device Distributing Enterprise License;

(C) quality management system certification, quality management documents;

(D) quality management training, inspection and quarantine institution qualified certificate;

(E) in the last two batches of imports each year evidence;

(Vi) comply with relevant state laws and regulations and the authenticity of the undertaking to provide information (self-declaration).

Inspection and Quarantine Bureau directly under Article IX shall, within five working days of the applicant to submit a written application for review. Missing application materials, the applicant should be required to make corrections.

Apply for a class of imported units, Inspection and Quarantine Bureau directly under the written examination should be done on the spot assessment after passing the examination, the examination results and related materials to the AQSIQ. AQSIQ import of a class of units that meet the conditions for approval of the applicant, and periodically announced a list of a class of imports.

Apply for two types of imported units, Inspection and Quarantine Bureau directly under the completion of a written examination, or entrust the unit can be located on their own inspection and quarantine institutions and organizations on-site assessment. Passing the examination, approval and report by the Inspection and Quarantine Bureau directly under the AQSIQ for the record, Inspection and Quarantine Bureau directly under the two types of regularly announced a list of imports.

Chapter imports of medical equipment and inspection and supervision of risk level

Article import inspection and quarantine agencies in accordance with the level of risk medical devices, the classification of imported units, according to the relevant provisions of the AQSIQ, on-site inspection of imported medical devices, as well as follow-up supervision and management (hereinafter referred to as supervision and inspection) combined The inspection and supervision model.

Article 11 The State Administration of Quality Supervision According to the structural features of imported medical devices, the use of form, condition, state rules related to medical device classification and import inspection management needs, the import of medical equipment products are: high-risk, high three risk and general risk level of risk.

Imported medical products catalog level of risk identified by the State Administration of Quality Supervision, adjustments, and announced 60 days before the date of implementation.

Article XII of the following conditions of imports of medical equipment products for high-risk rating:

(A) the implanted medical device;

(B) the active involvement of the human body medical devices;

(C) to support, life-sustaining medical equipment;

(D) the potential danger to human medical imaging equipment and energy treatment equipment;

(E) unstable product quality, the quality of several major accidents, the effectiveness of their safety must be strictly controlled medical devices.

Article XIII of the following conditions of imports of medical equipment products to a higher level of risk:

(A) passive medical devices involved in the human body;

(B) does not belong to high-risk human contact other active medical device;

(C) the less stable product quality, several quality problems, their safety and effectiveness of medical devices must be strictly controlled.

Article XIV is not included in the high-risk, high risk level of imported medical devices are generally risk level.

Article XV of imported high-risk medical devices, managed to test the following manner:

(A) the importer of a class imported, the implementation of on-site inspection and supervision of a combination of tests, including batch-site inspection in the rate of not less than 50%;

(2) 2, three types of imported units imported, the implementation of Pipi site inspection.

Article XVI higher risk of imported medical devices, managed to test the following manner:

(A) a class of imported units imported in batches on-site inspection of not less than 30%;

(B) the importer imports of second-class, in batches on-site inspection of not less than 50%;

(C) the import of three kinds of imported units, the implementation of Pipi-site inspection.

Article XVII risk of imported medical devices generally, the implementation of on-site inspection and supervision and inspection to test a combination of management, which in batches on-site inspection were:

(A) a class of imported units imported in batches on-site inspection of not less than 10%;

(B) the importer imports of second-class, in batches on-site inspection of not less than 30%;

(C) the three types of imported units imported in batches on-site inspection of not less than 50%.

Article 18 according to the needs of the AQSIQ's import of high-risk medical devices can follow the foreign trade contract, organization and implementation supervision, pre-shipment inspection and monitoring equipment.

Article 19 The import of medical equipment imported, the consignee of imported medical devices or their agents (hereinafter referred to as human inspection) to the declaration to be inspection and quarantine institution, and provide the following materials:

(A) the inspection requirements in the requested documents;

(B) are "mandatory product certification catalog" within the medical device, should provide China Compulsory Certification;

(C) the approval of the State Drug Administration sector registered a certificate of registration of imported medical devices;

(D) import unit for the first and second units of imports, should provide the import inspection and quarantine agencies to issue the classified documents.

Diershitiao port inspection and quarantine inspection agency shall review the material does not meet the requirements, it shall notify the inspection of people; after examination meet the requirements, the issue of "Immigration Customs Clearance of goods," goods customs declaration formalities, shall promptly report to inspection and quarantine institution for examination.

Twenty-one inspection of imported medical devices should be in person to declare the destination inspection test.

Installation and commissioning of the need to combine the implementation of inspection of imported medical devices should be used in the inspection, clearly, the use of inspection and quarantine agencies by the implementation of inspection. Require a combination of installation for the inspection of imported medical equipment catalog by the AQSIQ announced the implementation.

For implantable medical devices and other special products, should be specified in the State Administration of Quality Supervision Inspection and quarantine agencies to implement testing.

Article 22 The inspection and quarantine agencies in accordance with the mandatory requirements of national technical standards for imported medical equipment inspection; the development of national technical specifications have not yet mandatory, and can refer to the AQSIQ of the relevant foreign standards designated for inspection.

Article 23 The inspection and quarantine agencies to conduct on-site inspection of imported medical devices and monitoring tests may include:

(A) consistency of product and related certificate of verification;

(B) the quantity, specifications and appearance of the test;

(C) packaging, labeling and marking of tests, such as using wood packaging must be quarantined;

(D) instructions, a random verification of documents;

(E) mechanical, electrical, electromagnetic compatibility and other safety inspection;

(F) radiation, noise, biological and other health tests;

(G) emissions of toxic and hazardous substances, materials and other residues and environmental testing;

(H) involves diagnosis, treatment, medical device performance test;

(I) product identification, marking, and Chinese manual verification.

Article 24 The inspection and quarantine agencies to implement mandatory product certification system for imports of medical equipment to implement entry verification, inspection documents, check whether the goods match the card, if necessary, specify the laboratory samples may be taken in accordance with the mandatory product certification system and the state the relevant standards for testing.

Article 25 The import of medical equipment found by the test failed, inspection and quarantine authorities should issue a "proof of entry inspection and quarantine of goods."

The inspection found that failed the inspection and quarantine agency shall issue a "notice of inspection and quarantine process," required inspection certificate shall be issued claims. Related to personal safety, health, environmental protection projects failed, or you can handle the project by the technical processing technology is still unqualified after examination by the inspection and quarantine agencies shall order the parties to destroy or return and inform the Customs in writing and submitted to the State Quality Inspection Administration.

Chapter IV Inspection and Supervision import donated medical equipment

Article 26 The imported donated medical equipment should be unused, and shall not entrained hazardous environment, public health, goods or other prohibited items.

Article 27 prohibits the import donated medical equipment entrained included in our "banned the import of goods catalog" items.

Article 28 donated medical equipment to the Chinese territory of foreign donor agencies, or by their agents in China's State Administration of Quality Supervision for the donor and the donation of medical devices for the record.

Article 29 The State Administration of Quality Supervision, when necessary, import of donated medical equipment to the organization and implementation of pre-shipment inspection.

Article 30 The imported donated medical equipment to accept the unit or its agent shall hold the relevant approval documents to the customs inspection and quarantine institution, to use the inspection and quarantine agencies to apply for inspection.

Inspection and quarantine authorities of the relevant approval documents valid acceptance inspection, the implementation of port inspection, the use of ground test.

第三十一条 overseas donation of medical equipment inspection and quarantine institutions and issue a "proof of entry inspection and quarantine of goods", the recipient may use; by the unqualified, the Commodity Inspection Law and its implementing regulations in accordance with the relevant provisions .

Chapter V Risk Warning and Rapid Response

Article 32 The State Administration of Quality Supervision to establish the risks for imported medical devices early warning mechanism. By importing medical equipment and other defects in the information gathering and assessment, in accordance with relevant regulations issued alerts, and take appropriate risk warning measures and rapid response measures.

Article 33 The inspection and quarantine agencies to be regularly informed of the area using state of the quality of imported medical devices and found that the quality of imported medical equipment major accidents, shall report to the AQSIQ.

Article 34 The imported medical devices manufacturer, importer and the use of units found defective medical devices in the inspection and quarantine institutions shall report on the inspection and quarantine institutions to take the risk warning measures and rapid response measures should be required.

Article 35 of defective imported medical devices risk warning measures include:

(A) risk to the inspection and quarantine agencies issued warning notification to enhance the production of defective products manufacturer and importer of imported medical devices inspection and supervision;

(B) the defective product to the manufacturer, importer risk warning notices issued, urging the timely measures to eliminate risks;

(C) the use of units issued to the consumer and the risk warning notice, reminding them of their imports of medical equipment defect risks and hazards;

(D) to the domestic authorities, relevant national and regional liaison offices or embassies, international organizations and bodies of the situation, it is recommended to take the necessary measures.

Article 36 of defective imported medical devices rapid response measures include:

(A) propose to suspend the use of defective medical devices;

(B) adjusting the defective imported medical equipment imported units of the type of category management;

(C) to stop the import of defective medical devices;

(D) suspend or revoke the defective imported medical devices national mandatory product certification certificate;

(E) other necessary measures.

Chapter VI Supervision and Administration

Article 37 The inspection and quarantine authorities in each of the first and second importer of at least one supervision and examination, found that one of the following conditions, according to the severity of their treatment for the lower classes:

(A) the importer adverse credit record;

(B) the import of medical equipment there are significant safety hazards or major quality problems;

(C) the inspection and quarantine institutions, import unit failure occurs in batches of imported batches of up to 10%;

(D) The annual import batches of import unit does not meet the requirements;

(E) the importer has violated laws and regulations of other acts.

Lower class, the import unit must be within 12 months after the application to restore the original classification management category, and must be re-appraisal, approval, publication.

Article 38 The imported medical devices, one of the following conditions, inspection and quarantine institutions approved by the responsible person, you can import medical devices for seizure or detention, but the goods under customs supervision, except:

(A) are prohibited imports;

(B) health and safety deficiencies exist or may cause health risks and environmental pollution;

(C) likely to endanger life and property safety of patient health, the situation is urgent.

Article 39 The AQSIQ is responsible for the implementation of import inspection and quarantine inspection and supervision and management of medical equipment qualification training and assessment work. Without passing the examination shall not engage in the import of medical equipment inspection and supervision work.

Article 40 and the other for research purposes in patients with non-role in the import of used medical equipment, by the State Administration of Quality Supervision and other relevant departments for approval before the import.

The original re-create the import of medical equipment, its safety and technical performance to meet the new medical equipment should meet the requirements and comply with other relevant state regulations, the inspection and quarantine agencies for conformity assessment, the parties approved by the State Administration of Quality Supervision can be imported.

Banned the import of the preceding two paragraphs other than the old medical equipment.

Chapter VII Liability

第四十一条 unauthorized sale and use of untested or not inspection of a statutory inspection of imported medical devices, or the unauthorized sale and use of validation should be applied without application of import imported medical devices by the inspection and quarantine agencies shall confiscate the illegal income, the amount of goods and impose more than 5% 20% penalty; constitute a crime shall be held criminally responsible.

Article 42 The sale and use by the statutory inspection, random inspection or verification unqualified imported medical equipment, inspection and quarantine agencies ordered to stop by the sales, use, confiscate the illegal income and illegally sold, used goods, and impose illegal sale, use equivalent amount of goods for more than three times the fine; constitutes a crime, be held criminally responsible.

Article 43 The import of medical equipment unit of importing countries banned the import of old medical devices, in accordance with relevant state regulations shall be returned or destroyed. Import of used medical equipment is a mechanical and electrical products, the circumstances are serious, by the inspection and quarantine authorities impose a fine of 100 yuan.

Article 44 The inspection and quarantine agencies abuse their powers, deliberately making things difficult for the relatives and friends, false test results, or negligence, delay in issuance of certificates of inspection, shall be given administrative sanctions; constitutes a crime, be held criminally responsible.

Chapter VIII Supplementary Provisions

Measures referred to in Article 45 of the imported medical equipment, is from the outside into the Peoples Republic of China, alone or in combination in the human apparatus, equipment, apparatus, material or other items, including supporting the use of software, to its use for disease prevention, diagnosis, treatment, care, mitigation, diagnosis of the injury or disability, treatment, care, mitigation, compensation for anatomical or physiological process studied, alternative, regulation, control of pregnancy and so on.

Measures referred to in the import of medical equipment defects, is not in line with national mandatory standards, or may endanger the existence of personal and property safety of the unreasonable risk of imported medical devices.

This approach is referred to the import unit has a legal personality, has signed a medical device and perform the import or entrust foreign trade import agent contract medical equipment companies in China.

Article 46 from the outside into the bonded zones, export processing zones and other customs supervision areas for use of medical devices, as well as from the bonded areas, export processing zones and other customs supervision areas into other areas within the medical device, in accordance with the Regulations.

Article 47 The import of medical equipment for animal reference to these Measures.

Article 48 The import of medical equipment belonging to the boiler and pressure vessel, and its safety supervision and inspection shall also comply with other relevant provisions of the AQSIQ. A "People's Republic of imported measurement instruments catalog type review" the import of medical devices, should also comply with national laws and regulations relating to the measurement.

Article 49 These Measures shall be interpreted by the AQSIQ.

Article 50 These Measures shall December 1, 2007 shall come into force.