Chapter I General Principles
Article 1 In order to strengthen the supervision and management of medical device manufacturers, standardize the order of the production of medical devices, according to the "Regulations for the Supervision and Administration of Medical Devices", the formulation of these measures.
Second Where the Chinese people **** and the country to start medical device manufacturers and drug supervision and management departments at all levels, shall comply with these measures.
Article 3 to open the first class of medical device manufacturers, should be located in the provinces, autonomous regions and municipalities directly under the Central Drug Administration for the record.
The opening of the second, third class medical device manufacturers, should be the location of the province, autonomous region, municipality directly under the central drug supervision and management department for examination and approval, and issued a "medical device manufacturer license.
Chapter II conditions for the start of enterprises
Article 4 to open the second class of medical device manufacturers must have the following conditions:
(a) The person in charge of the enterprise shall have secondary education or above, or more than junior title.
(B) the person in charge of the quality inspection organization shall have college education or above or intermediate or above title.
(C) the enterprise should occupy the corresponding proportion of the total number of employees above the junior title of engineering and technical personnel.
(d) the enterprise should have the appropriate product quality inspection capabilities.
(E) should be compatible with the production of products and scale of production, warehousing sites and environment.
(F) has the appropriate production equipment.
(vii) The enterprise shall collect and save the laws, regulations, rules and relevant technical standards related to the production and operation of the enterprise.
(viii) the production of sterile medical devices, should have a production site in line with the provisions.
Article V to open the third class of medical device manufacturers in addition to the conditions set out in Article IV, but also shall have the following conditions:
(a) hold the quality system internal auditor certificate of full-time staff of not less than one.
(B) with the corresponding professional title of intermediate or higher full-time engineering and technical personnel not less than two.
(C) full-time inspectors not less than two.
Article VI Provinces, autonomous regions and municipalities directly under the Central Drug Administration shall, in conjunction with the actual situation in the jurisdiction, develop the implementation rules for the accreditation of medical device manufacturers, reported to the State Drug Administration for the record. Production requires special management of medical equipment varieties of enterprise qualification recognition of the implementation of the rules, by the State Drug Administration organization to develop and promulgate the implementation.
Chapter III filing and approval
Article VII of the first class of medical equipment manufacturers should fill out a unified filing form, the location of the provincial, autonomous regions, municipalities directly under the Central Drug Administration for the record. Record form by the record department copied to the enterprise where the municipal drug supervision and management department.
Article VIII of the third class of medical equipment manufacturers, by the local provinces, autonomous regions and municipalities directly under the Central Drug Administration for approval, reported to the State Drug Administration for the record.
Article IX provinces, autonomous regions, municipalities directly under the Central Drug Administration received the second class, the third class of medical devices manufacturer's application, must be based on the implementation of the rules for the recognition of qualifications of enterprises, enterprises to carry out on-site review, and within thirty working days to make a decision whether or not to issue a license. If the license is not issued, the reasons shall be stated in writing. Enterprise on-site review can be entrusted to the next level of drug supervision and management departments responsible for the implementation.
Chapter IV Management of Manufacturing Enterprises
Article X. Medical device manufacturers beyond the approved scope of production of medical devices, must re-execute the approval procedures.
Article XI of the medical device manufacturers shall not produce medical devices without the "Chinese People's Republic of China **** and the State Medical Device Registration Certificate".
Article XII of the production of Class III medical device enterprises shall establish and effectively implement the quality tracking and adverse reaction reporting system.
Article XIII of the medical device manufacturers shall not sell their products to the business units without "Medical Device Business Enterprise Record Form" or "Medical Device Business Enterprise License" or medical institutions without practice permit.
Article XIV of the "medical device manufacturer license" is valid for five years, six months before the expiration of the period, the enterprise shall submit an application for renewal, according to the provisions of the renewal procedures.
Article XV Provinces, autonomous regions and municipalities directly under the Central Drug Administration is responsible for organizing the "Medical Device Manufacturer License" annual validation work.
"Medical Device Manufacturer License" for each period of one year, the enterprise should be self-examination, and the self-examination report to the local provinces, autonomous regions and municipalities directly under the central drug supervision and management department, and at the same time put forward an application for verification. Provinces, autonomous regions, municipalities directly under the central drug supervision and management department deems necessary, the enterprise can be re-examined on-site. Annual review failed, should be ordered to rectify. Renewal of the enterprise is no longer validated that year.
Article XVI of the second class, the third class of medical device manufacturers to stop production for more than one year to re-organize production, shall be submitted in advance to the location of the provincial, autonomous regions and municipalities directly under the central drug supervision and management department of a written report. After review and approval, before re-organization of production.
Article XVII of the medical device manufacturer to replace the legal representative or person in charge, change the name, the production site must be located in the province, autonomous region, municipality directly under the central drug supervision and management department to apply for change procedures.
The second class, the third class of medical device manufacturers to change or increase the production site should be approved by the local province, autonomous region, municipality directly under the Central Drug Administration before production.
Chapter V Other Provisions
Article XVIII of the "Medical Device Manufacturer Filing Form" and "Medical Device Manufacturer License" by the State Drug Administration unified printing. Medical Device Manufacturer License" is divided into the original, a copy, a copy of the annual verification records. Record number is written in the format of: X1 drug control equipment production preparation XXXX2XXXX3; license number format: X1 drug control equipment production license XXXX2XXXX3; which: X1: the record or approval of the department's location (provinces, municipalities and autonomous regions) of the abbreviation; XXXX2: the year; XXXX3: the order of the number.
Article 19 of the "Medical Device Manufacturer License" approved product range should be determined in accordance with the "China Medical Device Product Classification Directory" in the management category, class code name.
Chapter VI Penalties
Article 20 Violation of the provisions of Article 13 and Article 14 of these Measures, by the drug supervision and management departments at or above the county level shall order its correction and give a warning.
Article 21 violation of the provisions of Article 12, Article 16, by the county-level drug supervision and management department shall order its correction and impose a fine of 10,000 yuan.
Article 22 has been approved by the enterprise without authorization to reduce the production conditions so that the product fails to meet the quality standards, in accordance with the "supervision and management of medical devices regulations" shall be punished.
Article 23 violation of the provisions of Article 10 of these measures, by the county-level drug supervision and management department shall order its correction, and impose a fine of 30,000 yuan.
Article 24 Provinces, autonomous regions and municipalities directly under the Central Drug Administration in violation of the provisions of this Measures issued medical device manufacturer's license, by the State Drug Administration ordered it to make corrections.
Chapter VII Supplementary Provisions
Article 25 These Measures shall be interpreted by the State Drug Administration.
Article 26 These measures shall April 20, 2000 shall come into force.