NMPA updates fast-track rules for devices

China is preparing to turbocharge medical device reviews and approvals, according to amended guidelines released by the National Medical Products Administration (NMPA). The rules are focused on“Special review and approval procedures for medical devices”, and are based on feedback from industry stakeholders provided against an earlier draft issued in 2018.

The NMPA is set to make fast-track treatment available to three different product types: 1. Core products that are basically standardized; 2. Products with invention patents; 3. Devices that are innovative and of significant clinical valuable.

Medical devices used to treat rare diseases, malignant tumors, geriatric diseases, childhood diseases with obvious clinical advantages, and medical devices that are in urgent clinical need with no similar products filed for marketing, and those classed as a National Science and Technology Major Project or National Key Research and Development Project, are encouraged to be filed for priority review and approval channels. In addition, there is an emergency approval special channel for devices to treat dengue fever, Zika virus, and hand, foot and mouth disease.

The NMPA is also working on "basic principles for conditional approvals of medical devices in urgent clinical need”. The CMDE released a draft proposal for said policy in April 2018, seeking public feedback on technical conditional marketing filing review and approval of domestic Class III, imported Class II and Class III clinical urgently needed medical devices.


Related news
The Center for Medical Device Evaluation (CMDE) released new guidelines on "Expert Consultation and Public Demonstration Standard Procedures".
China's Center for Medical Device Evaluation (CMDE) released a draft guidelines on “Technical Review of In Vitro Diagnostic (IVD) Reagent Licensing Changes”.
China's Center for Drug Evaluation (CDE) released draft “Medical Device Registration Review Correction Technical Guidelines”, a set of requirements designed to standardize the process of correcting and supplementing medical device filings.
Just before China's October national holiday, the National Medical Products Administration (NMPA) released draft amendments to three major guidelines affecting the pharma industry.
China's regulators are steadily addressing the risks and challenges represented by the rise of artificial intelligence (AI)-backed technologies.
Recent news
Chile’s Ministry of Health (MINSAL) this week announced measures against gender and age inequalities regarding Welfare Health Institutions (ISAPREs) fees.
Brazil-based Biolab, the leading seller of cardiology medicines in the Brazilian market, has signed an agreement with France-based Quantum Genomics to partner on the development, production, and commercialization in Latin America of a novel treatment for hypertension.
According to preliminary data from Mexico’s 2018 National Health and Nutrition Survey (ENSANUT), chronic diseases have continued to increase in the country since the previous survey in 2012.
Shandong province is set to scrap mark-ups on medical consumables at public medical institutions, according to a document released by the province.
US-based AbbVie’s Bruton’s tyrosine kinase (BTK) inhibitor ABBV-105 and Janus kinase 1 (JAK1) inhibitor upadacitinib (trade name: Rinvoq) have both won clinical trial approvals from the Center for Drug Evaluation (CDE).
China’s national drug use monitoring platform, online since November 25, now covers a network of 8,840 medical institutions and is handling an average 600,000 person visits daily, according to the National Healthcare Commission (NHC).
US-based biotech Amgen (Nasdaq.AMGN) trumpeted a new indication approval for its PCSK9 inhibitor Repatha (evolocumab) in China.
Analytics Snapshot

Analytics Snapshot