The recently revised “Regulation on the Supervision and Administration of Medical Devices” can benefit from the publication of these fields

Original title: The recently revised “Regulation on the Supervision and Administration of Medical Devices” is published, and these areas can benefit from it 丨 Bull Bear’s Eye

On March 18, the “Supervision of medical devicesmanagementRegulationsAnnounced, it will be implemented as of June 1, 2021. The “Regulations” implement the reform measures of “delegation of powers, regulation of services and promotion of innovation and development of the industry.” Bring medical device innovation into development focus, streamline approval and archiving procedures, implement implicit approval for clinical trials, shorten review period, and implement informational archiving.

The “Regulations” implement the registration and filing system for medical devices, and strengthenbusinessmain bodyresponsibility.It is stipulated that the registrant and the registrar will establish and operate effectivelyqualityManagement system, strengtheningproductPost-market management, establish and implement product tracking and recall systems, and conduct research and development, production andOperating, The safety and effectiveness of the entire process of use will be responsible in accordance with the law.

china postValuesHe said that the recently revised “Regulation” emphasized fostering innovation, further promoted industrial innovation from the institutional level and stimulatedmarketInternal vitality, thus promoting medical devices.industryHigh-quality development. The recently revised “Regulation” clearly put medical device innovation at the center of development,Innovative doctorPriority device review and approval, supportInnovative doctorClinical promotion and use of medical devices to promote the high-quality development of the medical device industry;Credit, Tenders, procurement, medicalSureSupport in other areas, so that the innovation system can be improved at the national level.Market spaceIn general, the industry is developing towards standardization and innovation, it is recommended to focus on the type of platformthe companyAnd subfields with innovative capabilitiesLeading company。

　　CICCInvestigation reportFocusing on the “LDT Legalization Policy” in the “Regulations”, the agency stated that the liberalization of the LDT model is an important benefit for the ICL industry. In the early stage of LDT method development, it is basically impossible to achieve automation and requires more manual intervention. Therefore, ICL has naturally become the largest breeding ground for LDT; this regulation also facilitates the incubation of products in the molecular diagnostics industry. As a leading representative in the field of special inspections, the molecular diagnostics industry covers popular topics such as complementary diagnostics and early tumor detection.CICCIt is recommended to attach importance to the molecular diagnostics and ICL industry.investmentOpportunities, ICL Industry Recommended Goals:Golden Field Medical、Dean Diagnosis; Recommended target for the molecular diagnostics industry:Ed bio、Genetron。

(Source: China Business News)

(Editor-in-charge: DF546)