The second batch of catalogues will be reopened with "green light": 359 device products can be exemp

The medical device industry is also enjoying important benefits - from September 30, 359 medical device products can be exempted from clinical trial "treatment".

According to the Notice of the State Food and Drug Administration on the Issuance of the Second Batch of Medical Devices for Clinical Trials (hereinafter referred to as the “Notice”), the Catalogue of the Second Class of Medical Devices Exempted from Clinical Trials (Second Batch) And the products covered in the Catalogue of the Third Class of Medical Devices (Second Batch) exempted from clinical trials, the applicants for registration may not need to carry out clinical trials, but should submit relevant information about the products in accordance with the regulations when applying for registration. Compare clinical data such as data.

The "Notice" pointed out that in order to implement the relevant provisions of the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations"), the State Council's opinions on reforming the examination and approval system for drug medical devices were actively implemented. The State Administration of the People's Republic of China conducted extensive research and public consultation. Fully study and demonstrate that under the premise of ensuring the safety and effectiveness of medical devices, according to the "Regulations", "Administrative Measures for the Registration of Medical Devices" and "Administrative Measures for the Registration of In Vitro Diagnostic Reagents", the organization has formulated the second "free of clinical trials". The Catalogue of Medical Devices (Second Batch) and the Catalogue of Class III Medical Devices Exempted from Clinical Trials (Second Batch) expand the range of medical devices that are exempt from clinical trials.

The two catalogues published this time involved a total of 359 products, including 267 second-class medical devices and 92 third-class medical devices. Of particular concern is the inclusion of 15 second in vitro diagnostic reagents, such as the albumin detection reagent (bromocresol green method).

The relevant person in charge of the Department of Medical Device Registration of the State Administration of Taxation told the reporter that all the second and third types of in vitro diagnostic reagent products had to submit clinical trial data, and the catalogue published this time included in vitro diagnostic reagents for the domestically vigorous in vitro development. The diagnostic reagent industry is a major benefit and will further promote the rapid development of the in vitro diagnostic reagent industry.

The reporter learned that the "Regulations" promulgated in March 2014 have made new designs for the medical device technology evaluation system. Article 17 establishes the medical device clinical trial exemption system and requires the establishment of medical devices exempt from clinical trials. The catalogue enables companies to prove that the clinical use of the product is safe and effective through clinical evaluation. Moreover, the "Regulations" reconstructed the content framework of medical device technology evaluation, not only replaced the registered product standards with product technical requirements, but also established the legal status of clinical evaluation methods, and started the registration inspection, technical review, sampling inspection, and re-evaluation. And so on, the corresponding provisions have been made. Since then, the State Food and Drug Administration has continuously improved and worked on the medical device technology evaluation system, and issued a number of normative documents closely related to medical device technology evaluation.