Medical Device Business License Management Measures Implementation Rules
Chapter I General
Article 1 In order to strengthen the supervision and management of medical device business enterprises, standardize the operation of medical devices, based on the "Medical Device Business License Management Measures" (State Food and Drug Administration Decree No. 15), to formulate these rules.
Second, Shandong Province, within the administrative region of the "Medical Device Business License" of the issuance, renewal, change and supervision and management of the application of these rules.
Article 3 Shandong Province Food and Drug Administration is responsible for Shandong Province administrative areas of "medical device business license" issued, renewed, changed and supervision and management.
Shandong Province Food and Drug Administration commissioned by the municipal Food and Drug Administration to undertake its jurisdiction, "Medical Device Business License" license, renewal, change the acceptance of applications, material review and on-site verification, as well as for the "Medical Device Business License" change of registered matters.
The Food and Drug Administration at or above the county level is responsible for the daily supervision and management of the "Medical Device Business License" within its jurisdiction.
Chapter II Application for "medical device business license" conditions
Article IV of the second and third class of medical device products operating legal entities, unincorporated units and legal entities set up by the branch shall apply for "medical device business license". The State Food and Drug Administration except as otherwise provided.
Financial leasing of medical equipment products, medical equipment business enterprises or medical device manufacturers in the enterprise "medical device business enterprise license" or "medical device manufacturer license" set up business premises outside the registered address of medical equipment products, as well as medical device manufacturers to sell self-produced products outside the scope of medical equipment products, should apply for "medical equipment Business Enterprise License".
The unincorporated entities applying for the "Medical Device Business License" are limited to the operation of Class II medical device products or Class III medical device products in contact lenses and nursing fluids.
Article 5 The application for "medical device business license" shall have the following conditions:
(a) business managers (legal representative, responsible person, quality management, warehousing, etc.) to familiarize themselves with and implement the supervision and management of medical devices and the supervision and implementation of national laws and regulations and the province's regulations on the management of medical devices.
(ii) set up and the scope of business and business scale appropriate quality management organization or with full-time quality management. Quality management should be on duty (shall not be part-time in other enterprises and institutions, and other personnel within the enterprise shall not be part-time), regularly participate in relevant training, continuing education.
1. Business Class III medical device products, quality management should have a nationally recognized, and business products related to professional (medical devices, biomedical engineering, machinery, electronics, etc.) college degree or above, or intermediate or higher technical title in related disciplines.
Operating single-use sterile medical device products (single-use sterile medical device product catalog see Annex I), there should also be more than one holding a medical device quality management system internal auditor certificate of internal auditor.
2. Management of Class II medical device products, quality management should have a nationally recognized, and management of products related to the profession (medical devices, biomedical engineering, machinery, electronics, etc.) above the junior college degree or junior technical title.
3. Business hearing aids or contact lenses and nursing fluids, quality management should be recognized by the state of the third-party institutions or authorized to operate the manufacturer (including import agents) fitting technology training.
(C) with the scale of operation and business products appropriate technical training and after-sales service capabilities, or agreed to provide technical support by a third party.
1. Operating second and third class medical device products, technical training and after-sales service personnel should have a secondary school education or junior technical title of the product related to the business.
2. Business hearing aids or contact lenses and nursing fluids, after-sales service personnel should be recognized by the state third-party institutions or authorized to operate the production company (including the import agent) fitting technology training.
(d) has to meet the commercial requirements and with the scope of business and business scale, relatively independent of the indoor premises. Business premises should be consistent with the registered address of the enterprise premises.
1. Business Class II, Class III medical device products, the use of business premises should be no less than 40 square meters, the use of business premises of branches of legal entities should be no less than 25 square meters (except across the municipalities set up);
business hearing aids, the use of business premises should be no less than 25 square meters;
Business contact lens and care solution, the business premises should be no less than 10 square meters.
2. Business premises and warehouses, life and other areas should be separated. Place of environmental cleanliness, dry terrain, no sources of pollution. Premises indoor spacious, bright, hygienic, clean, roof, walls and floors are flat, no gaps, doors and windows are tightly structured.
3. The premises should have with the business products and scale of the samples and information display counters, shelves and documents, filing cabinets and fixed telephone, fax machines, computers and other facilities and equipment. Inside and outside the premises should be in line with the relevant provisions of the country, province and location of signs and advertising.
Hearing aid business, should also have an audiometer, hearing aid programmer and supporting microcomputers, otoscopes, ear lamps and audiometric room and other dispensing facilities and equipment.
Operating contact lenses and care solutions, should also have optometers, slit lamps, corneal curvature meter and other fitting instruments and equipment.
4. Across the municipalities set up branches, the conditions of business premises and its corporate enterprise conditions are the same.
(E) with commercial requirements and with the scope of business and scale of operation, in line with the product characteristics and standards of indoor warehouses.
1. Business Class II, Class III medical devices (hearing aids, contact lenses and nursing fluids, except for single-use sterile medical device products), the warehouse should be no less than 30 square meters;
Operation of single-use sterile medical devices, warehouses should be in the same building, the use of the area should be no less than 200 square meters.
2. Warehouse and office, living and other areas should be separated. Place of environmental cleanliness, dry terrain, no source of pollution. Clean and tidy warehouse, light, ventilation, dry, in line with the characteristics and standards of the product. Library roofs, walls and floors are flat, no gaps, doors and windows are tightly structured. To be inspected area (product), qualified area (product), unqualified area, return area and expiration date of the various divisions of the classification is clearly marked, sterile and implantable products should be set up special areas, special cabinets.
3. The warehouse is equipped with instruments, facilities and equipment required to meet the product characteristics and standards: temperature and humidity meters, pads, shelves, lighting, fire, light, ventilation facilities to meet the requirements of the necessary dust, moisture, pollution and insect, rodent and other facilities and equipment, and remain intact.
4. Branches of legal entities (except for the establishment of municipalities across the region) and specializing in medical equipment and equipment, may not set up a separate warehouse, but should be stamped with a legal entity or authorized to operate the product manufacturer (including the import agent) of the original seal of the original seal of the relevant procurement and distribution of uniform quality management, installation and after-sales service commitments, as well as the franchise product registration, authorization and other evidence. Documents and other proof.
Business hearing aids or contact lenses and their care solution, you can not set up a warehouse, but there should be a special cabinet storage.
5. Across the municipalities set up branches, warehouses, the same conditions as its corporate enterprise conditions.
6. Foreign provinces (municipalities directly under the Central Government) medical equipment business enterprises in Shandong Province administrative area to set up additional warehouses, warehouses should be set up in line with the relevant requirements of these rules, and has a warehouse with the main business interconnected to exchange medical equipment storage, access to data of the computer management system.
(F) the establishment and implementation of the relevant laws and regulations in line with the actual quality management system, regulations or quality management system documents. Quality management system, regulations include:
1. organization, personnel and functions of the regulations;
2. procurement control, purchase and acceptance, product return management system and quality verification methods;
3. warehouse management, out of the warehouse review management system;
4. non-conforming products handling management system;
5. quality Quality tracking, after-sales service and adverse event reporting management system;
6. Staff training management system;
7. Quality file management system, including the establishment and preservation of: the relevant national laws, regulations, rules and normative documents and national standards and industry standards related to the operation of the product files; medical device products and suppliers qualification files; medical equipment procurement, sales contracts (agreements), tickets and other documents.
8. Quality work record management system, including the establishment and maintenance of: product purchasing and purchase acceptance records; warehouse temperature and humidity records; products out of the warehouse review and sales records; product returns, replacement records; nonconforming products handling records; quality tracking, after-sales service and complaint handling records; adverse event report records; staff training records. The records are set up with detailed contents, filled in standardized, complete and true. Medical device purchase and sale records should be kept until more than the medical device expiration date of 2 years; no expiration date, should not be less than 3 years.
Business hearing aids and contact lenses and nursing fluids, should be prepared and implemented at the same time the fitting procedures.
Operation of single-use sterile medical devices, should be prepared and implemented at the same time in accordance with YY/T0287 in line with regulatory requirements and the actual quality management system documents, including the formation of documents, quality policy and quality objectives, quality manuals, the formation of documents, procedures, a variety of required records and regulations and other documents.
Article VI of the operation of medical device products require special management, shall at the same time comply with the corresponding requirements of the State Food and Drug Administration.
Chapter III Application for "Medical Device Business License" procedures
Article 7 The application for "Medical Device Business License" shall be submitted to the municipal Food and Drug Administration in the district to submit the following materials:
(a) "Medical Device Business License Application Form" (paper and electronic documents, instructions for filling out the form, see Appendix II, the application form style see Annex III)
(ii) a copy of the applicant's qualification certificate;
(iii) a copy of business license or pre-approval of enterprise name certification documents;
(iv) a copy of the qualification certificate of the quality management personnel in accordance with the provisions of Article 5 (b) of these Rules, a copy of ID card and personal history;
(v) in accordance with the provisions of Article 5 (c) of these Rules After-sales service personnel qualification certificates copies, copies of identity cards and personal resume;
(vi) business premises and warehouses in line with the provisions of Article 5 (4) and (5) of the Rules, geographical location map, floor plan indicating the area, copy of the document certifying the property rights of the house or the right to use;
(vii) in line with the provisions of Article 5 (f) of the Rules, the quality management system, regulations, or quality management system documents;
(viii) Declaration of authenticity assurance of the declared materials (see Annex IV for the format).
Article VIII of the applicant for the "medical device business license" license application, the municipal Food and Drug Administration shall be dealt with according to the following circumstances:
(a) the application does not belong to the department's terms of reference, it should be made immediately inadmissible decision, issued a "notice of inadmissibility" (see Annex V for the form), and inform the applicant Apply to the relevant departments;
(b) the declaration of the existence of errors that can be corrected on the spot, the applicant should be allowed to correct on the spot;
(c) the declaration of incomplete materials or do not meet the statutory form, should be issued on the spot or within five working days to the applicant to make corrections to the declaration of materials of a one-time notification (see Annex VI for the format), a one-time notification of the need to correct the All the contents. Late notification, from the date of receipt of the declaration is accepted;
(d) the application belongs to the department's terms of reference, the declaration materials are complete, in line with the statutory form, or the applicant in accordance with the requirements to submit all the corrections to the declaration materials, it shall be on the spot or within five working days to send the "Notice of Acceptance" (see Annex VII for the format). Notification of Acceptance" shall be stamped with a special seal of acceptance and indicate the date of acceptance.
Article IX of the municipal Food and Drug Administration shall accept the date of 15 working days in accordance with the requirements of these rules to complete the on-site verification of the applicant enterprise, and will apply for the enterprise's "Medical Device Business License Application Form" and business license or pre-approval of business name documents, corporate quality management qualification certificates copies, as well as the "Medical Device Business License Review Form" (style Annex VIII). Table" (style see Annex VIII), "medical device business on-site verification of the assessment of the situation" (style see Annex IX) each in a single copy at the same time to the Provincial Food and Drug Administration.
Article X of the Provincial Food and Drug Administration received a complete material, through the website (see Annex II) on the proposed licensing of enterprises to the public, the publicity period of five days. After the expiration of the publicity period, the Provincial Food and Drug Administration shall within 10 working days to make a decision on whether or not to issue a "medical device business license", and announced on the website. Considered in line with the requirements, should be made to grant the licensing decision, and within 10 working days from the date of the decision to the applicant issued a "medical device business license", that does not meet the requirements, it should be in accordance with the requirements of the written notice to the applicant, and copied to the applicant where the enterprise is located in the municipal Food and Drug Administration.
Objections raised during the publicity period, to be investigated and verified before processing.
The publicity time and the publicity of the objections raised during the investigation and verification of the time is not included in the approval time limit.
Article XI of the application for the operation of medical equipment products require special management (including single-use sterile medical devices), the declaration materials by the municipal Food and Drug Administration acceptance, acceptance of the date of five working days to the provincial Food and Drug Administration.
Provincial Food and Drug Administration received complete materials, in accordance with the relevant provisions and time limits to complete the application for on-site verification of enterprises, to make the decision whether to issue a "medical device business license".
Article XII of the Food and Drug Administration on the application of the on-site verification of enterprises should be selected by the provincial food and drug supervision and management department of medical equipment supervision and management of the training of personnel to participate. Verification team to implement the system of responsibility of the team leader.
Article XIII of the on-site verification personnel should be in accordance with the "Shandong Province medical device business on-site verification of the provisions of the business enterprise" and "medical device business on-site verification standards and records" (see Annex X) requirements for on-site verification, record keeping, and make on-site verification conclusions.
Chapter IV "Medical Device Business License" change and reissue
Article XIV "Medical Device Business License" project change is divided into licensing changes and registration changes.
Article XV of the medical device business enterprises to change the quality management personnel, registered address, scope of business, warehouse address (including the increase or decrease in the warehouse area) and other "medical device business license" licensing matters, should fill out the "Medical Device Business Change Application Form" (paper and electronic documents, see Annex XI, Annex XII) to the applicant's business location of the municipal Food and Drug Administration to submit an application and at the same time submit the application form to the applicant's business location. Drug Administration to apply, and also submit the original seal stamped with the business license "and" medical device business license "copy and approval of the higher authorities or board of directors (shareholders) resolution, declaration of authenticity of the materials to ensure that the statement. Changes in organizational structure and quality management system changes, should also provide organizational charts and in line with the provisions of Article V (6) of the Rules of quality management system, regulations or quality management system documents.
Change of quality management, should also be submitted in accordance with the provisions of Article V (2) of these rules, the proposed quality management of a copy of the certificate of qualification, a copy of ID card and resume;
Change of registered address or warehouse address, should also be submitted in accordance with the provisions of Article V (4) or (5) of the proposed change of the address after the geographic location of the map, the area of the labeled Floor plan, building ownership or right to use a copy of documents;
Change in the scope of business, should be submitted at the same time to operate a copy of the product registration certificate (to increase the scope) and related reporting materials.
Enterprises that have obtained the "Medical Device Business License" to apply for an increase in the need for special management of medical device products (including single-use sterile medical devices), should be submitted at the same time in line with the provisions of Article V (2) of these rules, a copy of the qualifications of the quality manager, a copy of the identity card and resume, in line with the provisions of Article V (5) of these rules, the geographic location of the warehouse map, The floor plan indicating the area, a copy of the document certifying the property right or right to use the house, in line with the provisions of Article 5 (6) of the Rules of the quality management system documents, as well as other materials specified by the state.
Trans-provincial jurisdiction to set up warehouses, should be submitted at the same time the following relevant materials stamped with the original seal of the enterprise (in triplicate):
(a) Medical Device Business License Change Application Form;
(b) "Medical Device Business License" copy;
(c) "Business License" copy;
(D) the proposed additional warehouse quality acceptance of personnel identity cards, certificates of academic qualifications or titles and copies of biographical information;
(E) the new warehouse location map, floor plan indicating the area, copy of documents proving property rights or the right to use the house, storage conditions.
Article XVI of the declaration materials are incomplete or do not meet the statutory form, the municipal Food and Drug Administration shall be issued on the spot or within five working days to "make corrections to the declaration materials a one-time notification" to inform the need to make corrections to all the contents at once. For the declaration materials are complete, in accordance with the statutory form, or the applicant in accordance with the requirements to submit all the corrections to the declaration materials, it should be on the spot or within five working days to send the "Notice of Acceptance".
Article XVII of the municipal Food and Drug Administration in the acceptance of "Medical Device Business License" permit matters change application within 10 working days from the date of this rule requires the completion of the on-site verification of the applicant, to make on-site verification of the conclusion and will apply for the enterprise's declarations and "Medical Device Business License Change Approval Form", "medical device business enterprise On-site verification assessment form" each in a single copy at the same time sent to the Provincial Food and Drug Administration.
Article XVIII of the provincial food and drug supervision and management department receives the complete materials, should be within 10 working days to make the decision to grant the change or not grant the change. Permitted to change, it should be for its "medical device business license" permit matters change procedures; not allowed to change, it should be in accordance with the requirements of the written notice to the applicant, while copying the applicant's business location of the municipal Food and Drug Administration.
Apply for additional warehouses across provincial jurisdictions, the provincial Food and Drug Administration review, the warehouse to draw the provincial food and drug supervision and management departments where the set of conditions to assist in on-site verification. After verification, the provincial Food and Drug Administration will be added to the warehouse address identified in the "Medical Device Business License".
Article XIX of the medical device business enterprises due to illegal operation has been investigated, but has not yet been closed; or has received the administrative penalty decision, but has not yet fulfilled the penalty, shall terminate the acceptance or review of its "Medical Device Business License" of the licensing matters of the change in the application, until the case is completed.
Article 20 of the medical device business enterprises to change the business name, legal representative, person in charge of the "Medical Device Business License" registration matters, should be approved by the administrative department for industry and commerce within 30 days after the change to fill out the "Medical Device Business Change Application Form" (paper and electronic documents) to the applicant's business location of the municipal Food and Drug Administration to apply for "medical equipment" registration, and the "Medical Device Business License" change. License" change registration, and submit the original seal stamped with the enterprise's new and old business license (change of business name should also be submitted at the same time to change the name of the enterprise to approve the document) copies, "Medical Device Business License" copies of the approval of the competent authorities and higher documents or the board of directors (shareholders' meeting) resolution, declaration of authenticity of the materials to ensure that the statement. Changes in organizational structure and quality management system changes, should also provide organizational charts and meet the provisions of Article V (6) of the Rules of the quality management system, regulations or quality management system documents.
Article 21 of the municipal Food and Drug Administration shall receive a complete "Medical Device Business License" within 15 working days from the date of change in the registration matters for its "Medical Device Business License" registration matters change procedures.
Article 22 of the enterprise separation, merger or across the original jurisdiction (district city) migration, shall be in accordance with the provisions of these rules to re-apply for the "medical device business license".
Article 23 After the change of the "Medical Device Business License" license number for the original license number after the addition of "(more)" word, the original validity period remains unchanged.
Article 24 of the enterprise due to force majeure causes "medical equipment business license" lost, destroyed, should be immediately to the location of the municipal Food and Drug Administration report, in the provincial Food and Drug Administration designated media on the loss of the statement, and submit "medical equipment business license replacement application form" (see Annex XIII for format), by the location of the city district Food and Drug Administration signed the opinion, stamped and reported to the provincial food and drug supervision and management departments. Provincial Food and Drug Administration should be published in the enterprise lost statement date of 1 month after the full, in accordance with its original approval of the reissue of "medical equipment business license".
Replacement of the "medical device business license" certificate number for the original certificate number after the addition of "(fill)" word, the original expiration date remains unchanged.
Article 25 "medical device business license" is valid for five years. The expiration of the validity period, the need to continue to operate medical equipment products, should be expired six months before the expiration date, but not less than three months to the applicant where the municipal Food and Drug Administration to apply for reissue of "medical equipment business license.
Article 26 The application for reissue of "medical device business enterprise license" shall be submitted as follows:
(a) "medical device business enterprise old license for a new license application form" (paper and electronic documents, see Annex XIV for the style);
(b) the original seal stamped with the original seal of the "Medical Device Business Enterprise License" copy of the copy of all the matters contained in the copy and a copy of business license;
(c) a copy of the "Medical Device Business Enterprise License" and a copy of the business license;
(d) a copy of the "medical device business enterprise license" and a copy of the business license. and a copy of the business license;
(iii) a copy of the applicant's qualification certificate;
(iv) a copy of the qualification certificate of the quality manager, a copy of the ID card, and a copy of the personal resume in accordance with the provisions of Article 5 (b) of these Rules;
(v) a copy of the qualification certificate of the after-sales service personnel, a copy of the ID card, and a copy of the personal resume in accordance with the provisions of Article 5 (c) of these Rules;
(6) in line with the provisions of Article 5 (4), (5) of the Rules of the geographical location of business premises and warehouses, floor plans indicating the area, housing ownership or right to use a copy of documents;
(7) in line with the provisions of Article 5 (6) of the Rules of the quality management system, the provisions of the quality management system or quality management system documents;
(8) the authenticity of the declaration materials Guarantee statement.
Article 27 of the Food and Drug Administration in accordance with the requirements and procedures set out in Chapter II and Chapter III of these rules on the renewal of the declaration materials accepted, on-site verification of the qualified, approval for the issuance of a new "medical device business license.
Article 28 of the replacement of enterprises in the receipt of new certificates at the same time shall return the original "medical device business license".
Article 29 The on-site verification of unqualified enterprises should be rectified. Since the on-site verification team issued a "notice of rectification" (see Annex XV) within 30 days from the date of on-site verification of the municipal Food and Drug Administration in charge of the area in writing to apply for on-site verification again. Overdue written application for on-site verification again, deemed to be withdrawn for the issue of "medical device business license" application. Its "medical device business license" in the expiration of the validity of the automatic cancellation.
The time for the enterprise to carry out rectification and the time for its on-site verification again is not included in the approval time limit.
Article 30 of the municipal Food and Drug Administration received a written application for on-site verification of enterprises again, should be completed within 15 working days of on-site verification again, and will apply for the relevant materials sent to the provincial Food and Drug Administration.
Order 31 again on-site verification of qualified, by the provincial Food and Drug Administration for approval of the issue of new "medical device business license.
Again failed on-site verification, by the Provincial Food and Drug Administration to review the decision not to renew the license, and in accordance with the requirements of the written notice to the applicant, while copying the applicant's business location of the municipal Food and Drug Administration. Its "medical device business license" in the expiration of the validity of the automatic cancellation.
Article 32 of the medical device business enterprises are no longer operating medical equipment products, should apply for "medical device business license" cancellation procedures. For cancellation shall be submitted to the local municipal Food and Drug Administration "Medical Device Business License Cancellation Registration Form" (see Annex XVI), the approval of the higher authorities or board of directors' resolution and "Medical Device Business License" original, copy of the original.
The cancellation of the recovery of "medical device business license" is, copy, the municipal Food and Drug Administration should be stamped with the cancellation of the seal and the establishment of archives for five years.
Article 33 of the municipal Food and Drug Administration of the administrative jurisdiction of the "medical device business enterprise license" expires without renewing the automatic cancellation and for "medical device business enterprise license" cancellation procedures, should be published on the website of the Municipal Bureau of information bulletin.
Chapter V Supervision and Management
Article 34 The municipal Food and Drug Administration in the region within the scope of the entrusted exercise of authority, shall not be entrusted in any way to the lower levels or other departments.
Article 35 The municipal Food and Drug Administration in the region to strictly implement the procedures and standards, in the declaration of material acceptance and on-site verification, etc., shall not arbitrarily increase the conditions, without a clear legal basis, shall not be accepted.
A variety of documentary materials (including paper and electronic) should be submitted or uploaded to the provincial Food and Drug Administration in a timely manner in accordance with the specified requirements.
Article 36 of the Provincial Food and Drug Administration of the municipal Food and Drug Administration should be inspected, found illegal, irregularities should be corrected in a timely manner.
Article 37 The Food and Drug Administration shall, in accordance with the "Medical Device Business License Management Measures", to strengthen the supervision and inspection of medical device business enterprises. Supervision and inspection of the situation and the results shall be recorded by the supervision and inspection of personnel and the legal representative of the enterprise (responsible person) or the parties concerned to sign and file and copy to the municipal food and drug administration. Municipal Food and Drug Administration shall announce and record the results of on-site inspection in the "medical device business license" copy. Medical Device Business License" copy of the record should be stamped with the municipal Food and Drug Administration's official seal.
Article 38 of the municipal Food and Drug Administration for "medical equipment business license" cancellation and change of registration shall be reported to the provincial Food and Drug Administration for the record on a monthly basis.
Article 39 of the unauthorized change of business premises and other medical equipment business enterprises can not be contacted, the municipal Food and Drug Administration shall be recorded and announced on the department's Web site, a deadline of 30 days to handle the formalities, overdue, reported to the Provincial Food and Drug Administration, the provincial Food and Drug Administration to cancel its "medical equipment business license".
Article 40 The Provincial Food and Drug Administration cancellation of the "medical device business license" shall be notified within five working days from the date of cancellation of the industrial and commercial administration and the municipal food and drug administration, and in the provincial bureau website to the community.
Article 41 of the cross-provincial jurisdiction to set up warehouses, should be in accordance with the "Regulations for the Supervision and Administration of Medical Devices" and the relevant provisions of the license to set up warehouses and bear the corresponding legal responsibility.
Trans-provincial jurisdictions set up warehouses can only engage in logistics activities related to the purchase and sale of the business.
Cross-provincial jurisdictions set up warehouses, by the warehouse where the food and drug supervision and management department for day-to-day management.
Chapter VI Supplementary Provisions
Article 42 The applicant referred to in these rules refers to the legal representative of the legal entity or the proposed legal entity; the person in charge of the unincorporated entity or the proposed unincorporated entity.
Article 43 of Shandong Province, issued by the "Medical Device Business License" number by the "Lu" plus six Arabic numerals, of which the first two Arabic numerals for the municipal code (see Annex XVII), the last four for the issuance of the "Medical Device Business License" of the sequential number.
Hold "Medical Device Business Enterprise License" of the corporate enterprise set up by the branch of the "Medical Device Business Enterprise License" number for the corporate enterprise "Medical Device Business Enterprise License" number after the addition of three-digit sequential number with "-".
Article 44 The main business scope listed in the "Medical Device Business Enterprise License" issued by Shandong Province is shown in Annex XVIII.
Article 45 The previous provisions of these rules are inconsistent with the implementation of these rules. The State Food and Drug Administration provides otherwise, the implementation of its provisions.
Article 46 These rules shall come into force on April 1, 2007. November 2, 2004 issued by the "Shandong Province," the medical device business license management measures "implementation rules" shall be repealed.