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 Administration for examination and approval, and issued a "medical device manufacturer license. Chapter II conditions for the establishment of enterprises Article IV 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 above junior title.
(B) the person in charge of the quality inspection organization should 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 category of medical device manufacturers in addition to the conditions set out in Article IV, must also have the following conditions:
(a) hold a 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) not less than two full-time inspectors. Article VI Provinces, autonomous regions and municipalities directly under the Central Drug Administration should be combined with the actual jurisdiction, the development of medical device manufacturers qualification recognition of the implementation details, reported to the State Drug Administration for the record.
Production requires special management of medical equipment varieties of enterprise qualification approval of the implementation of the rules, by the State Drug Administration organization to develop and promulgate the implementation. Chapter III filing and approval of Article 7 to open the first class of medical device manufacturers should fill out a unified filing form, reported to the local provinces, autonomous regions and municipalities directly under the Central Drug Administration for the record. The filing form by the record department copied to the drug supervision and management department of the city where the enterprise is located. Article VIII to open the third class of medical device 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, third-class medical device manufacturer's application, must be recognized in accordance with the implementation details of the qualification of the enterprise, the enterprise on-site review, and within thirty working days to make a decision on whether 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 10 The medical device manufacturer exceeds the approved scope of production of medical devices, must re-execute the approval procedures. Article XI of medical devices manufacturers shall not produce medical devices without the "Chinese People's **** 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 13 The medical device manufacturer shall not sell the products to the business unit without "Medical Device Business Enterprise Record Form" or "Medical Device Business Enterprise License" or the medical institutions without practice permit. Article XIV "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 of the license, in accordance with 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 verification.
"Medical Device Manufacturer License" for each full 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, third class medical device production enterprises to stop production for more than one year to re-organize production, shall be submitted in advance to the local province, autonomous region, municipality 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 medical equipment manufacturers to replace the legal representative or person in charge, change the name, production sites must be located in the provinces, autonomous regions, municipalities directly under the Central Drug Administration 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 18 "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.
Filing number is written in the format:
X1 drug control equipment production preparation XXXX2XXXXXX3;
License number format:
X1 drug control equipment production license XXXX2XXXXXX3;
Which:
X1: filing or approval of the department's location (provinces, municipalities directly under the Central Government, autonomous regions) Abbreviation;
XXXX2: year;
XXXX3: sequential number.