The Guideline on Preparation of Medical Device Technical Requirements

This guiding principle is made according to Medical Device Supervision and Management Regulations and relevant regulations.

Article 1 Basic Requirement

1. The compilation of medical device technical requirements shall confirm to relevant state laws and regulations.
2. The medical device technical requirements shall use standard and general terms. Proving well-definition of special terms which are used and recording them into “4.Terms” part.
3. The each content number of testing methods in the medical device technical requirements shall be consistent with the each content number of performance index in principle.
4. The words, numbers, formula, unit, symbols and graphics and so on in the medical device technical requirements shall comply with the standardization.
5. The medical device technical requirements reference by the National Standard, Industry Standard or Chinese Pharmacopoeia which shall be ensure effective, and specify the number, era of the standard and the version of Chinese Pharmacopoeia.

Article 2 Content Requirement

The content of the medical device technical requirements shall comply with the following requirements.

1. Product name. The product name in the medical device technical requirements shall be used in Chinese, and be consistent with the Chinese name in the register (record) file.
2. Product Model/Specifications, Partition Specification. Ensure the model and/or the specification of the product, and partition specification in the medical device technical requirements. Ensure the distinction between each model and specification if multiple model and/or specification exist in the same registered unit. Provide the text of model/specification as attachment if the text is too long. 
3. Performance Index                                                                                                                                                                        3.1  Performance index in the medical device technical requirements is used to judge the functionality, security index, and other index related to quality control objectively. Evaluative contents in product design and development (e.g. biocompatibility evaluation) shall not be set in the medical device technical requirements in principle.                                                                                                              3.2  Performance index shall be developed refer to the relevant regulations of National Standard/Industry Standard and combine with the product design features, intended use, and quality control standard. The performance index shall not fall short of the applicable National Standard/Industry Standard.                                                                                                                                                          3.3  Making sure of the specific requirements of performance index which shall not be provided in form of “see attached files” and “according to supply contracts” in the medical device technical requirements.
4. Test Methods                                                                                                                                                                         Test methods shall be adjusted with the corresponding performance index. Recognized and issued standard test methods shall be preferable considered. The development of test methods shall to ensure reproducible and maneuverability. Definite the preparation methods of sample as needed, and if necessary, can attach with the corresponding drawings for description, and if the text is too long, can provide the text as attachment.                                                                                                                                             For in vitro diagnostic reagent products, the reference/standard substance, preparation methods, batches and lots of reagents used in the test, test times and computational method shall be specified in the test methods.
5. For Class III in vitro diagnostic reagent, the major raw-materials, production technology and requirements of semi-finished product shall be definite in the form of appendix in the medical device technical requirements.
6. The number of medical device technical requirements shall be the corresponding registration number (record number).                         It can be blank if the product is planned to be registered or recorded.

Article 3 Format Requirements

See attachments.