CDSCO to regulate all non-notified medical devices in phased manner to ensure patient safety
The
Central Drugs Standard Control Organisation (CDSCO) has come out with an action
plan to regulate all medical devices under Drugs and Cosmetics (D&C) Act in
a phase wise manner to ensure safety, quality and performance of medical
devices. This will also include diagnostic kits manufactured and imported in
the country.
As of today, only 23 categories of medical devices are
regulated under the provisions of D&C Act 1940 which cover around 400
medical devices amongst the 5,000 odd unregulated medical devices which pose
risk to patient safety.
Many of the medical devices like equipment, analysers,
instruments, etc. used in healthcare facilities for diagnosis, treatment and
mitigation are currently out of the scope of regulation under D&C Act.
The union health ministry had earlier constituted a committee
on the issue. After detailed deliberations with different stakeholders, the
committee has finally recommended that all medical devices should be regulated
under D&C Act, 1940 in a phase wise manner.
In the first phase, all manufacturers and importers of all
non-regulated medical devices should register the details of the devices
manufactured and imported by them in a special SUGAM portal to be developed for
this purpose and a notification should be issued under the D&C Act in this
regard.
Such registrations should initially be on voluntarily basis
for up to 18 months from the date of notification. Thereafter, it should
be made mandatory for all importers and manufacturers in the country.
During this phase, all manufacturers and importers should
report the Serious Adverse Events (SAEs) to CDSCO as well as to
Materiovigilance Programe of India (MvPI) so that these reports could be
analysed to assess the safety and performance of the devices and take
appropriate regulatory interventions to ensure patients safety.
Similarly cases of complaints on such devices regarding
failure in Quality Management System (QMS), design, product quality etc.,
should be reported to CDSCO for appropriate investigation and regulatory
actions to ensure quality, safety and performance of the medical devices
marketed in the country.
In the second phase, registration of Class A and B devices
shall be followed by mandatory licensing within 12 months after 18 months of
registration period is over i.e. for manufacture, import and marketing of all
low risk medical devices falling under Class A and Class B, notified under
first phase.
Requirement of prior license under medical device (MD) Rules,
2017 should be made mandatory within 12 months after implementation of
provision of registration under phase one.
After the 12 months period, no person, company, organization
should be allowed to manufacture, import, sale or distribute Class A and Class
B medical devices without prior license under the MD Rules, 2017.
In the third phase, registration of Class C and D devices
shall be followed by mandatory licensing within 24 months after 18 months of
registration period is over i.e. all high risk MD falling under Class C and D
notified under 1st phase. Requirement of prior license under MD Rules, 2017
should be made mandatory within 24 months after implementation of provision of
registration under phase one.
After the 24 months period, no person, company, organization
should be allowed to manufacture, import, sale or distribute Class C and Class
D medical devices without prior license under the MD Rules, 2017.
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