2021 LS&HC Horizons - Flipbook - Page 53
Life Sciences and Health Care Horizons 2021
53
Compassionate use of medical devices allowed in China on a trial basis
After the draft version has been issued for
more than half a year, on 14 March 2020, the
NMPA and the National Health Commission
(NHC) jointly released the Measures on the
Administration of Extended Clinical Trials of
Medical Devices (for Trial Implementation),
which officially establish the system of
“compassionate use” for investigational medical
devices in China enabling patients in China who
suffer from serious diseases can have early access
to new therapy.
The compassionate use of investigational
medical devices occurs where the patients who
are not participants to the clinical trials uses
the investigational medical devices in clinical
trial institutions. The compassionate use can
be initiated provided that certain conditions
have been satisfied: (i) the patient is of a lifethreatening disease for which there has been no
effective therapy and is unable to participate in
the clinical trial since the enrollment process
for clinical trial has been completed; (ii) the
researchers decide that risks resulting from the
disease itself outweighs the risks resulting from
using the medical device and the anticipated
benefits outweigh the possible harms; (iii) the
scope of application for such medical device
will not exceed the scope in the clinical trial;
(iv) it should be carried out in the same
institutions where the clinical trials of such
medical devices have been conducted; and (v)
the institution and the researcher meet the
corresponding qualifications.
Several documents need to be executed in
advance, including the informed consent form
executed by the patients and the agreement
signed by the patients, researchers, sponsor
and clinical trial institution to clarify the rights
and obligations among the parties. In terms of
regulatory formalities, the sponsor is required to
make record-filing with the local branch of the
National Medical Products Administration, and
the clinical trial institution is required to report
to the local NHC office where the trial site(s)
is located.
Roy Zou
Office Managing Partner, Beijing
roy.zou@hoganlovells.com
Lu Zhou
Partner, Beijing
lu.zhou@hoganlovells.com
Jessie Xie
Senior Associate, Beijing
jessie.xie@hoganlovells.com
The team provides prompt and succinct
advice that considers legal requirements
and business needs.
Life Sciences Client,
Chambers Asia-Pacific, 2021
