NMPA and National Health Commission jointly issued the Administrative Measures of Medical Device Expanded Access for Clinical Trial on March 20, implementing from the date of publication. The draft version was published on August 29, 2019.
The important document, intended to get clinical trials for patients who are in life-threatening conditions without effective treatment, sets forth the requirements of rights and responsibilities, initiation scenarios, process management, data collection.
How to Qualify?
Expanded access of clinical trials are for severely life-threatening diseases that do not yet have effective treatments under the following prerequisites:
- Preliminary observations show the benefits to patients;
- Meet the ethical requirements;
- Have Informed Consent;
- Clinical trial site shall be NMPA-certified;
- The medical device is used in the same site as ongoing or completed trials
- The Instruction for Use and Scope of Application for the medical device for extended access should be the same as those in ongoing or completed clinical trials.
Who can Apply?
The patients, clinical trial sponsors and investigators can apply for the expanded access.
Who Signs Agreement?
Subjects, researchers, sponsors and clinical trial institutions should sign a Quartet Agreement, clarifying their rights and responsibilities.
The sponsor shall file the expanded trial with provincial NMPA, and the clinical trial institution shall report to the local health administrative department. Provincial NMPA shall process the application based on “Announcement of the National NMPA Concerning the Filling of Medical Devices Clinical Trial”.
How to Submit Data?
When applying for medical device registration or submitting supplementary data, applicants shall submit data based on review requirements such as NMPA guidelines and industry standards. The NMPA also published Evaluation Reports for 23 innovative devices to educate manufacturers on the vital points to get market approval (click HERE for our post).
The data analysis mainly focuses on safety data and take into account of efficacy data. The safety data mainly focuses on the incidence, duration, and severity of adverse events.
About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal representative with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.