Summary: In adherence to the Medical
Device Regulation India, the audit of premises manufacturing drugs is
compulsory. It is an important part of the regulation process after drug product
registration in India.
The CDSCO or Central Drugs Standard
Control Organization recently released a list of notified bodies who will be
responsible for auditing the manufacturing premises under the provisions of
Medical Device Rules, 2017.
According to the notice, the
regulatory authority has registered eight notified bodies, thereby giving them
the responsibility to carry out audits of the manufacturing sites of drugs and
medical devices in India. The rules came into effect in January of 2018. It
covers all matters based on production, import, registration as well as
distribution including the post-market surveillance of the medical devices.
According to the rule 12 of the
Medical Device Rules 2017, a notified body will be responsible for auditing the
manufacturing sites of medical devices belonging to Class A and Class B. They
have to scrutinize whether the devices comply with the required Quality
Management System and other required standards as per the State Licensing
Authority.
DCGI has clearly stated that only
those notified bodies can carry out the required auditing of companies who are
involved in the production of medical devices. The notified bodies selected
must have at least two years of experience along with well-qualified
specialists. The registration of those bodies will remain valid until their
suspension is granted by the CDSCO.
Following is the list of the notified
bodies that can perform auditing of manufacturing companies of medical devices:
● Intertek India
Pvt. Ltd.
● TUV Rheinland
India Pvt. Ltd.
● TUV SUD South
Asia Pvt. Ltd.
● Dnv GL
Business Assurance India Private Limited
● BSI Group
India Pvt. Ltd.
●
BSCIC Certifications PVT. LTD.
●
TUV INTERCERT SAAR INDIA PRIVATE LIMITED.
●
Zenith Quality Assessors Pvt. Ltd.
What roles
will these notified bodies play?
The notified bodies are responsible
for the proper implementation of the regulation process of the medical devices
in India. Solo auditing by the government authorities can lead to more pressure
on their workforce. Who already has to manage other tasks like processing of
new market applications, granting registrations and post-market supervision.
Thus, the notified bodies will act as affiliated official bodies that will
enhance efficiency and service quality of the overall procedure.
As per the Medical device rules,
those notified bodies listed are the legal authorities responsible for
performing the assessments as well as verification of certain special
categories of medical devices.
The primary role of these notified bodies
is conducting assessments for confirmation like scrutinizing information based
on evidence available and processes offered by medical device manufacturers to
estimate the compliance with the safety requirements and the whole performance
of the medical devices as required.
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