In order to implement the Regulations on the Supervision and Administration of Medical Devices and the Opinions of the State Council on the Reform of the Examination, Assessment and Approval System of Medical Devices (No. 44, National Development [2015]), the former State Food and Drug Administration promulgated the Catalogue of Medical Devices (hereinafter referred to as the new Catalogue) on August 31, 2017. It will come into effect in 018 August 1st. To ensure the smooth and orderly implementation of the new classified catalogue, the relevant issues are read as follows:
I. classification and coding of * * Medical Devices
In accordance with the relevant requirements of the Notice on the Implementation of the Catalogue of Medical Devices (No. 143, hereinafter referred to as Notice No. 143, 2017), the Notice on the Issue of the Catalogue of ** Medical Devices (Notice No. 8 of the State Food and Drug Administration, 2014) and the General Office of the General Administration of Food and Drug Administration on the Issue of the Catalogue of ** Medical Devices Notice on the Implementation of the Matters Relevant to the Recording of Class** Medical Devices (No. 174 of the Food and Drug Administration) and the Classification and Definition Opinions on Classification and Definition of Class** Medical Devices in the Classification and Definition Documents of Medical Devices issued after 30 May 2014 remain valid.
In order to unify the classification codes of ** medical devices, the State Drug Administration (SDA) has correlated the catalogues of ** medical devices and the products of ** medical devices mentioned in the subsequent classification and definition documents with the new Catalogue (see annex). Since August 1, 2018, the classification codes of ** medical devices in the new Catalogue have been used in the filing process.
Two. Regarding the adjustment of categories, it is necessary to record products related to * * products.
In accordance with the requirements of Circular 143, after the implementation of the new Catalogue, the registrant shall, six months before the expiry of the validity period of the medical device registration certificate, apply to the corresponding food and drug supervision and administration department for renewal of registration or for filing in accordance with the changed category. The food and drug supervision and administration department shall issue the registration certificate of medical devices in accordance with the new Catalogue for the renewal of registration; make the registration certificate if the materials for the record meet the requirements; and mark the original registration certificate number in the registration record column or the change of the registration certificate.
In view of the above-mentioned cases, the applicant shall provide the original registration certificate of the product, together with the filing materials, and submit it it to the corresponding food and drug regulatory authorities. If the filing materials meet the requirements, the corresponding food and drug regulatory authorities shall prepare the Filing Certificate and indicate the original registration certificate of the product in the filing certificate. Number.
Three. Principles of classification and coding for medical devices with combined packages.
The classified codes of the package products should be the classified codes of the package products with the same class of medical devices, and the classified codes of the package products with the same class of medical devices which play a major role in their intended use should be the classified codes of the package products.
Four. Feedback on Relevant Issues in the implementation of the new classified catalogue.
The State Drug Administration has established a mechanism for coordinating and resolving relevant problems in the implementation of the new Catalogue, and promptly organized relevant departments to study and solve them. Medical device supervision departments at all levels, medical device enterprises and relevant departments involved in the implementation of the new Catalogue management category issues, can be feedback to the original Food and Drug Administration Medical Device Standards Management Center, address: 31 Huatuo Road, Daxing District, Beijing, postcode: 102629.
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