|
India Changes Medical
Device Application Processing System
On January 1, 2024, the Central Drug Standard Control
Organisation (CDSCO) released a notice (ref.
IT-13011(11)/1/203 link, pdf) regarding use of the Nation
Single Window System (NSWS) portal. India’s application
processing system is changing to the NSWS, which will be
replacing the old processing system, CDSCO MD Online.
Initially, only three activities under MDR 2017 were
developed and made operational on the NSWS portal January
1, 2024.
However, on January 16, 2024, the CDSCO expanded upon its
activities and added more forms (link, pdf). The added
forms are as follows:
1. Form MD-01 – Application for grant of Certificate of
Registration of a Notified Body.
2. Form MD-12 – Application for grant of license to
manufacture medical device for purpose of clinical
investigations, test, evaluation, examination,
demonstration or training.
3. Form MD-16 – Application for grant of license to import
medical device for purpose of clinical investigations or
test or evaluation, or demonstration or training.
4. Form CT-10 – Request for authority to manufacture new
or experimental drugs for use in bioavailability or
bioequivalence tests, clinical trials.
5. Form CT-12 – Request for approval to create a
formulation with an unapproved active pharmaceutical
ingredient for use in analysis, bioequivalence, clinical
trials, or other studies involving bioavailability.
6. Form CT-13 – Application for permission to manufacture
unapproved active pharmaceutical ingredients for clinical
trials, formulation development, analysis, testing, and
bioavailability and bioequivalence research.
7. Form CT-16 – Request for permission to import new or
experimental drugs for testing, analysis, and inspection
purposes, as well as for use in bioavailability or
bioequivalence studies and clinical trials.
8. Form 12 – Application for license to import drugs for
purpose of examination, test or analysis.
In the future, we envisage that all applications to CDSCO
including Form MD-15 (application for a medical device
Import License) will be processed through NSWS.
Critically, the implementation of single-window pathways
is expected to increase operation efficiencies, especially
as the number of
covered regulatory pathways increases to include import
and manufacturing licenses for medical devices.
https://asiaactual.com/blog/india-changes-medical-deviceapplication-processing-system/
CDSCO To Switch PSUR
Submission Of Medical Devices And In-vitro Devices To
Online System
As part of the ongoing efforts to digitise and streamline
the regulatory submission procedure, the Central Drugs
Standard Control Organisation (CDSCO) has switched the
submission of Period Safety Update Reports (PSUR) related
to marketing authorisation of medical devices and in-vitro
devices to the online system. The offline mode of
submission of these applications will be discontinued from
April 1, 2024.
The drug regulator said that the system for submission of
PSURs with regards to marketing authorisation of medical
devices and in-vitro devices is functional now through the
online system for medical devices portal.
"All applicants submitting PSURs’ shall apply through
Online System for Medical Devices as per checklist in the
portal. The facility of offline submission of applications
in hard copy or any other mode will not be available for
processing from April 1, 2024," said Dr Rajeev Singh
Raghuvanshi, Drugs Controller General (India).
It may be noted that in February, CDSCO has switched the
submission of Period Safety Update Reports (PSUR) related
to marketing authorisation of new drugs and others to
online system.
The drug regulator has been in an effort to switch various
application and approval processes related to its office
to online mode in recent years, as part of implementation
of an e-governance mechanism in the organisation.
Last November, the CDSCO directed all stakeholders to
submit the applications for Post Approval Changes (PACs)
with regard to marketing authorisation for human vaccines
and antisera through online system of Sugam Portal under
Post Approval Changes, as it is stopping the offline
submission process from December 1, 2023.
In the beginning of 2023, CDSCO switched the procedure for
submission of form for test license for veterinary
vaccines and drugs to online, stopping the facility of
offline submission of applications in hard copy following
this. In 2021, it has switched the applications for
registration of centres for Bioavailability and
bioequivalence (BA/BE) studies and application for PACs in
BA/BE studies online.
The CDSCO launched the National Single Window System (NSWS)
portal on January 1, 2024, initially offering three
activities for the medical devices industry, in an effort
to improve the ease of doing business to the industry.
NSWS is established by the central government with the
objective to build a Single Window System which acts as a
onestop shop for all the approvals required by the
investor and facilitates ease of doing business. The scope
of NSWS includes all the approvals/licenses/clearances as
acceptable.
The CDSCO has said that the portal for the drug regulator
has been developed by Invest India through IT major Tata
Consultancy Service (TCS) and this will be an independent
portal from the existing SUGAM portal or the cdscomdonline
portal, which is for the medical devices industry.
The drug regulatory organisation has also, in November,
2023, initiated efforts to set up a Digital Drugs
Regulatory System (DDRS) as a unified digital ecosystem as
a single window, single sign on and unified portal for all
regulatory activities.
The proposed DDRS is aimed at building trust and
confidence in the quality of drugs, medical devices,
cosmetics, etc., in the domestic and global market,
transparency and accountability in the regulation of the
quality, effective enforcement of quality, safety and
efficacy at the field level, and ensuring compliance to
Indian pharmacopoeia & standards, according to the CDSCO.
https://www.pharmabiz.com/NewsDetails.aspx?aid=168101&sid=1
March 22, 2024
Health Regulator Seeks
Private Labs for Quality Testing of Medical Devices
The health regulator agency of India is looking for
private testing laboratories to test medical devices and
create a mechanism of testing to ensure the quality and
safety of medical devices sold in India, News18 has
learnt.
Medical devices include blood pressure monitors,
thermometres, glucose meters, ventilators and prosthetic
limbs.
The Union government’s health regulatory agency - Central
Drugs Standard Control Organisation (CDSCO) — has advised
eligible private laboratories to submit applications to
its office to grant licenses.
As all medical devices are now regulated under the
umbrella of Medical Devices Rules (MDR), 2017, the law
provides an avenue for private testing laboratories to
obtain licenses as government approved facilities for
testing medical devices and issuing required test
certificates.
“To strengthen the private testing facility for medical
devices in the country, this office is in the process of
identifying the existing private labs having the facility
to test the medical devices, so that these labs may be
registered under Medical Devices Rules (MDR), 2017,” said
the notice issued by the drug regulator of India, who
heads CDSCO.
The notice, issued on April 3, highlighted that medical
devices require multiple tests, including physical,
chemical, microbiological, mechanical and electrical.
The regulator has requested laboratories to identify if
their facility can run these tests for medical devices and
submit the application for registration of testing
laboratory on behalf of the manufacturer.
MOVE OVERDUE BUT NEEDED MORE DISCUSSIONS: EXPERTS
Experts say the move was overdue but needs a coordinated
consultation approach between several authorities and
departments.
Rajiv Nath, managing director, Hindustan Syringes &
Medical Devices (HMD), hailed the move while adding that
more discussions are required for a successful
implementation.
Nath, who is also the forum coordinator of Association of
Indian Medical Device Industry (AIMED) said they have been
pushing the Union government for the same for over two
years. “The move requires a coordinated consultation
approach between Bureau of Indian Standards (BIS), Quality
Council of India (QCI), National Accreditation Board for
Testing and Calibration Laboratories and Indian Institutes
of Technology (IITs), existing reputed private
laboratories, government labs and manufacturers.”
Dr PV Appaji, former director-general, the Pharmaceutical
Export Promotion Council of India (Pharmexcil), called the
move “a big opportunity for all existing labs”. He said
that the government in a “proactive measure” has
encouraged eligible private laboratories.
https://www.news18.com/india/health-regulator-seeks-privatelabs-for-quality-testing-of-medical-devices-8841835.html
APRIL 06, 2024.
|
