The Measures for the Administration of Licenses for Medical Device Trading Enterprises was reviewed and approved by the State Food and Drug Administration on June 25th, 2004, and is hereby promulgated, and shall come into force as of the date of promulgation.
Measures for the Administration of Licenses for Medical Device Business Enterprises
Chapter I General Principles
Article 1 In order to strengthen the supervision and administration of the business license of medical devices, these Measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.
Article 2 These Measures shall apply to the issuance, renewal, alteration, supervision and administration of the Medical Device Business License.
Article 3 Whoever engages in the operation of Class II and Class III medical devices shall hold a Medical Device Operation License. However, a small number of second-class medical devices that can ensure their safety and effectiveness through routine management in the circulation process may not apply for a medical device business license. The catalogue of Class II medical device products that do not need to apply for the Medical Device Business License shall be formulated by the State Food and Drug Administration of the United States.
Article 4 The State Food and Drug Administration of the United States shall be responsible for the supervision and administration of the national medical device business license.
The (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the issuance, renewal, alteration, supervision and administration of the Medical Device Business License within their respective jurisdictions.
The municipal (food) drug supervision and administration institution with districts or the county (food) drug supervision and administration institution directly established by the (food) drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government is responsible for the daily supervision and administration of the business license of medical devices within its jurisdiction.
Article 5 The State Food and Drug Administration of the United States shall gradually implement the standardized management system for the operation quality of medical devices. The quality management standards for medical devices are formulated by the US Food and Drug Administration.
Chapter II Application Conditions for Medical Device Business Enterprise License
Article 6 To apply for the Medical Device Business License, the following conditions shall be met at the same time:
(1) Having a quality management organization or full-time quality management personnel suitable for the business scale and scope. Quality management personnel should have relevant professional qualifications or titles recognized by the state;
(2) Having a relatively independent business place suitable for its business scale and business scope;
(3) Having storage conditions suitable for the business scale and business scope, including storage facilities and equipment that meet the requirements of medical device product characteristics;
(four) establish and improve the product quality management system, including procurement, purchase acceptance, warehousing, outbound audit, quality tracking system and adverse event reporting system;
(5) It shall have the technical training and after-sales service capabilities suitable for the medical device products it deals in, or agree to provide technical support by a third party.
Article 7 An application for the License for Medical Device Trading Enterprises must be accepted by the (food) drug supervision and administration department.
The (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall, in accordance with these measures and in light of the actual situation in their respective jurisdictions, formulate inspection and acceptance standards for medical device trading enterprises and report them to the State Food and Drug Administration for the record.
Article 8 The business scope specified in the Medical Device Business License shall be determined according to the management category and category code specified in the Medical Device Classification Catalogue.
Chapter III Application Procedures for Licenses of Medical Device Business Enterprises
Article 9 The (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the applicant enterprise is located or the entrusted (food) drug supervision and administration department of the city divided into districts shall be responsible for accepting the application for the issuance of the Medical Device Business License.
Article 10 The (food) drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government or the entrusted (food) drug supervision and administration department of a city divided into districts shall publish the conditions, procedures, time limit, all materials and demonstration texts of the medical device business license application on the website of the administrative organ or the application acceptance place.
Article 11 The following materials shall be submitted when applying for the Medical Device Business License:
(1) Application Form for Medical Device Business License;
(2) The certificate of pre-approval of enterprise name issued by the administrative department for industry and commerce;
(3) A copy of the identity card, education or professional title certificate and resume of the quality management personnel of the enterprise to be established;
(4) The organizational structure and functions of the proposed enterprise;
(5) A copy of the geographical location map, floor plan (indicating the area) and property right certificate (or lease agreement) of the registered address and warehouse address of the proposed enterprise;
(six) the product quality management system documents and the catalogue of storage facilities and equipment of the enterprise to be established;
(7) The business scope of the proposed enterprise.
Article 12 An applicant shall apply to the (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the enterprise to be applied for is located or the (food) drug supervision and administration department of the city divided into districts entrusted by it for issuance of the Medical Device Business License.
For the applicant's "Medical Device Business License" application, the (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government or the entrusted (food) drug supervision and administration institution of the city with districts shall deal with it respectively according to the following circumstances:
(a) the application matters do not belong to the scope of authority of the department, it shall immediately make a decision not to accept, send a notice of rejection, and inform the applicant to apply to the relevant departments;
(2) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot;
(3) If the application materials are incomplete or do not conform to the statutory form, the applicant shall issue a Notice of Supplementary Materials on the spot or within five working days to inform all the contents that need to be supplemented at one time. Fails to inform, since the date of receipt of the application materials is accepted;
(4) Where the application matters fall within the authority of the department, the application materials are complete and conform to the statutory form, or the applicant submits all the corrected application materials as required, it shall issue a notice of acceptance. The acceptance notice shall be stamped with the special seal for acceptance and indicate the date of acceptance.
Article 13 The (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government or the entrusted (food) drug supervision and administration institutions of cities divided into districts shall conduct on-site verification of the enterprises to be applied for according to the acceptance standards of medical device trading enterprises, and review the application materials according to these Measures.
Fourteenth provinces, autonomous regions and municipalities directly under the central government (food) drug supervision and management departments shall make a decision on whether to issue the "medical device business license" within 30 working days from the date of acceptance. If it meets the requirements, it shall make a decision on granting the medical device business license, and issue the medical device business license to the applicant within 10 days from the date of making the decision. Do not meet the conditions, it shall notify the applicant in writing and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.
Article 15 When examining an applicant's application, the food and drug supervision and administration department shall announce the examination and approval process and results. Applicants and interested parties may submit written opinions, make statements and defend matters directly related to their major interests.
If the application for medical device business license directly involves the significant interests between the applicant and others, the (food) drug supervision and administration department shall inform the applicant and interested parties of the right to apply for a hearing according to law.
(Food) If the drug supervision and administration department considers that the business license of medical devices involves public interests, it shall make an announcement to the public and hold a hearing.
Sixteenth provinces, autonomous regions and municipalities directly under the central government (food) drug supervision and management departments shall publish the relevant information of the "medical device business license" that has been issued, and the public has the right to inquire.
Chapter IV Alteration and Renewal of the License for Medical Device Business Enterprises
Seventeenth "medical device business license" project changes are divided into licensing changes and registration changes.
Changes in licensing items include changes in quality management personnel, registered address, business scope and warehouse address (including adding or deleting warehouses).
The change of registered items refers to the change of other items except the above-mentioned items.
Article 18 Where a medical device business enterprise changes the licensed items of the Medical Device Business License, it shall fill in the Application for Change of the Medical Device Business License, and submit a copy of the business license and the Medical Device Business License stamped with the enterprise seal.
In case of any change in quality management personnel, a copy of the ID card, academic certificate or professional title certificate of the new quality management personnel shall be submitted at the same time; Where the registered address of an enterprise changes, it shall also submit the property right certificate of the changed address or a copy of the lease agreement, geographical location map, floor plan and description of storage conditions; Where the business scope is changed, a copy of the registration certificate of the products operated and the corresponding description of storage conditions shall be submitted at the same time; Where the warehouse address is changed, the property right certificate of the changed warehouse address or a copy of the lease agreement, geographical location map, floor plan and description of storage conditions shall be submitted at the same time.
Article 19 Where a medical device trading enterprise applies for changing the licensed items, the (food) drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government or the entrusted (food) drug supervision and administration department of a city divided into districts shall, within 15 working days from the date of accepting the application of the medical device trading enterprise for changing the licensed items, conduct an audit according to the acceptance criteria of the medical device trading enterprise, and the (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government shall make a decision on whether or not to approve it. If on-site acceptance is required, a decision on approval or disapproval of the change shall be made within 20 working days from the date of acceptance.
Where the (food) drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government makes a decision to approve the change, it shall record the contents and time of the change on the copy of the License for Medical Device Business; If it does not change, it shall inform the applicant in writing and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.
After the medical device business enterprise changes the licensing items of the Medical Device Business License, it shall go through the relevant enterprise registration change procedures with the administrative department for industry and commerce according to law. After the change, the validity period of the medical device enterprise license remains unchanged.
Twentieth medical device business enterprises have been investigated by the (food) drug supervision and administration department for illegal business, but the case has not been closed; Or has received the decision of administrative punishment, but has not yet fulfilled the punishment, the (food) drug supervision and administration department of the province, autonomous region or municipality directly under the central government or the entrusted (food) drug supervision and administration department of the city divided into districts shall suspend the acceptance or review of the application for the change of the licensing items of the Medical Device Business License until the case is handled.
Article 21 Where a medical device trading enterprise changes the registered items of the Medical Device Trading Enterprise License, it shall fill in the Application for Change of the Medical Device Trading Enterprise License within 30 days after the change is approved by the administrative department for industry and commerce, and apply to the (food) drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government or the (food) drug supervision and administration institution of a city divided into districts for registration of change of the Medical Device Trading Enterprise License. The (food) drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government or the entrusted (food) drug supervision and administration institution of a city divided into districts shall handle the change procedures for it within 15 working days from the date of receiving the application for change, and notify the applicant.
Article 22 After the registered items of the Medical Device Business License are changed, the (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government or the entrusted municipal (food) drug supervision and administration institutions with districts shall record the contents and time of the change on the copy of the Medical Device Business License. After the change, the validity period of the medical device enterprise license remains unchanged.
Article 23 Where an enterprise is divided, merged or moved across the original jurisdiction, it shall reapply for the Medical Device Business License in accordance with the provisions of these Measures.
Article 24 The validity period of the Medical Device Business License is 5 years. If it is necessary to continue to operate medical device products at the expiration of the validity period, the medical device operating enterprise shall apply to the food and drug supervision and administration department of the local province, autonomous region or municipality directly under the Central Government or the municipal food and drug supervision and administration institution with districts for renewal of the Medical Device Operating Enterprise License six months before the expiration of the validity period.
The (food) drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government or the (food) drug supervision and administration institution of a city divided into districts shall examine the application for renewal of license in accordance with the provisions of these Measures.
The (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall make a decision on whether to approve the renewal before the expiration of the validity period of the Medical Device Business License. If no decision is made within the time limit, it shall be deemed that it is agreed to be replaced, and the corresponding procedures shall be handled.
If the (food) drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government considers that it meets the requirements, it shall issue a new license at the expiration of the validity period of the Medical Device Business License and withdraw the original Medical Device Business License; Do not meet the requirements, it should be rectified within a time limit. If it still does not meet the requirements after rectification, it shall cancel the original Medical Device Business License at the expiration of the validity period, inform the applicant in writing and explain the reasons, and inform the applicant that he has the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.
Article 25 If a medical device trading enterprise loses its License for Medical Device Trading Enterprise, it shall immediately report to the (food) drug supervision and administration department, and publish a loss statement in the media designated by the (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government. The (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall, after 1 month from the date when the enterprise issues the loss statement, renew the License for Medical Device Business according to the original approval. The validity period of the renewed Medical Device Business License is the same as that of the original Medical Device Business License.
Chapter V Supervision and Inspection
Twenty-sixth superior (food) drug supervision and management departments should strengthen the supervision and inspection of the lower (food) drug supervision and management departments in the implementation of medical device business license, and promptly correct the illegal acts in the implementation of administrative license.
Article 27. The (food) drug supervision and administration department shall establish a file on the issuance, renewal, alteration, supervision and inspection of the Medical Device Business License, and report the issuance, renewal, alteration, supervision and inspection of the Medical Device Business License in the last quarter to the (food) drug supervision and administration department at the next higher level. The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall establish archives for the expired and legally recovered Medical Device Business License and keep them for 5 years.
Article 28 (Food) The drug supervision and administration department shall strengthen the supervision and inspection of medical device trading enterprises. The main contents of supervision and inspection include:
(a) the name of the enterprise, the legal representative or the person in charge of the enterprise and the change of quality management personnel;
(2) Changes in the registered address and warehouse address of the enterprise;
(3) Business premises, storage conditions and main storage facilities and equipment;
(four) the implementation and change of important matters such as business scope;
(five) the implementation of the enterprise product quality management system;
(six) other related matters that need to be checked.
Twenty-ninth supervision and inspection can take the form of written inspection, on-site inspection or a combination of written inspection and on-site inspection. In any of the following circumstances, the (food) drug supervision and administration department must conduct on-site inspection:
(1) Enterprises newly established in the previous year;
(2) Enterprises with problems in the previous year's inspection;
(3) Enterprises subject to administrative punishment for violating relevant laws and regulations;
(four) other enterprises that the food and drug supervision and management department deems it necessary to conduct on-site inspection.
Thirtieth "medical device business license" renewal year, supervision and inspection and renewal review can be carried out together.
Article 31 (Food) When conducting supervision and inspection of medical device trading enterprises according to law, the drug supervision and administration department shall record the supervision and inspection and the handling results, and file them after being signed by the supervision and inspection personnel. (Food) The drug supervision and administration department shall announce and record the on-site inspection results on the copy of the Medical Device Enterprise License.
Thirty-second in any of the following circumstances, the original issuing authority shall cancel the Medical Device Business License:
(a) the medical device business enterprise license expires, and it has not been applied for or not renewed;
(two) the medical device business enterprise terminates its operation or closes down according to law;
(3) The License for Medical Device Trading Enterprise has been revoked, withdrawn, revoked, withdrawn or declared invalid according to law;
(four) the medical device business enterprise can not operate normally due to force majeure;
(5) Other circumstances in which the license of a medical device trading enterprise shall be cancelled according to laws and regulations.
(Food) If the drug supervision and administration department cancels the License for Medical Device Business Enterprise, it shall notify the administrative department for industry and commerce within 5 working days from the date of cancellation and make an announcement to the public.
Chapter VI Legal Liability
Article 33 If a medical device trading enterprise changes its quality management personnel without authorization, the (food) drug supervision and administration department shall order it to make corrections within a time limit. Those who refuse to make corrections within the time limit shall be fined more than 5000 yuan 10000 yuan.
Article 34 Where a medical device trading enterprise changes its registered address and warehouse address without authorization, the (food) drug supervision and administration department shall order it to make corrections within a time limit and impose a fine of not less than 5,000 yuan but not more than 20,000 yuan on informed criticism.
Article 35 If a medical device business enterprise expands its business scope and lowers its operating conditions without authorization, the (food) drug supervision and administration department shall order it to make corrections within a time limit, give informed criticism a fine of 6,543,800 yuan and 20,000 yuan.
Article 36 Where an applicant conceals relevant information or provides false materials to apply for the Medical Device Business License, the (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government or the entrusted (food) drug supervision and administration institutions of cities with districts shall not accept the application or issue the "Medical Device Business License" and give a warning. The applicant shall not apply for the Medical Device Business License again within 1 year.
Article 37 Where an applicant obtains the Medical Device Business License by cheating, bribery or other improper means, the (food) drug supervision and administration department shall revoke its Medical Device Business License, give it a warning and impose a fine of not less than 20,000 yuan but not more than 6,543,800 yuan. The applicant shall not apply for a medical device business license again within 3 years.
Article 38 If a medical device trading enterprise commits any of the following acts, the (food) drug supervision and administration department shall order it to make corrections within a time limit and give it a warning; Those who refuse to make corrections within the time limit shall be fined 1 10,000 yuan but not more than 20,000 yuan:
(1) Altering, reselling, leasing or lending the Medical Device Business License or illegally transferring the Medical Device Business License in other forms;
(two) to carry out business activities beyond the business scope specified in the license of the medical device business enterprise;
(3) Concealing relevant information, providing false materials or refusing to provide true materials reflecting its operation during supervision and inspection.
Thirty-ninth other cases that violate the provisions of relevant laws and regulations in the issuance, replacement, change, supervision and management of the Medical Device Business License shall be handled in accordance with the provisions of relevant laws and regulations.
Chapter VII Supplementary Provisions
Article 40 The Business License for Medical Devices includes an original and a copy. The original and copy of the License for Medical Device Business Enterprises have the same legal effect. The original License for Medical Device Business Enterprises shall be placed in a prominent position in the business premises of medical device business enterprises.
The License for Medical Device Enterprises shall specify the name of the enterprise, the names of the legal representative, responsible person and quality management personnel, business scope, registered address, warehouse address, license number, license number, issuing authority, date of issuance, validity period and other matters.
Article 41 The License for Medical Device Business Enterprises shall be uniformly printed by the State Food and Drug Administration of the United States. The original and duplicate styles and numbering methods of the Medical Device Business License shall be uniformly formulated by the State Food and Drug Administration of the United States.
Article 42 These Measures shall be implemented as of the date of promulgation. Order of the State Administration of Medical Products. 19 the measures for the supervision and administration of medical device enterprises shall be abolished at the same time.
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