Regulatory Issues In Contract Manufacturing (Out Sourcing)
Of Medical Devices
Mr. Sanjay Shah
Unikal Consultants Ahmedabad
devices are unique in their definition and it has
large varieties which are covered under the term
medical devices. They are classified under various
categories mainly depended on its usage and risk
involved in their intended application and use.
regulations covering medical devices are also have
many requirements to be complied with. Thus all
aspects of development, manufacture, sales and post
sales support are complex processes. Quality aspect
pre- & post manufacturing is a very complex in their
nature based on their application and usage.
at the complexity of manufacturing of medical devices
outsourcing or contract manufacturing becomes an
accepted process. There are companies which are
experts at designing, expert at component
manufacturing of various types like moulding,
companies which only assemble different components and
companies which carry out sterilization process.
There is a possibility that
some companies are proficient at conceptualization and
final labelling and marketing. Thus as per MDD/93/42
concept of OBL (own brand labelling) has been accepted.
Thus Establishments that are
involved in the production and distribution of medical
devices intended for commercial distribution are required
to list the devices and the activities performed on those
devices at that establishment.
Establishment Activities as per FDA
Contract Manufacturer -
Manufactures a finished device to another establishment's
Contract Sterilizer -
Provides a sterilization service for another
Why Consider Outsourcing to
a Contract Manufacturer?
Manufacturing may not be a
core competency of an organization.
The device requires high
development and clinical costs, which may limit the
resources required to engage in high quality and high
objectives result in the consideration of reducing company
overhead, including facility costs or a reduction in
Contract manufacturers are
hired to build small subassemblies (many build complete
assemblies) that then will be sent to the client for final
assembly into a larger unit.
It can reduce costs and
provide access to expertise that is not available in
Contract manufacturing is
generally defined as the production of goods or services
by one company under the label or brand name of another
company. Contract manufacturers (CMs) may provide such
services to several organizations based on customer (or
CM-generated) designs, formulas, and/or specifications.
Contract manufacturing is a form of outsourcing.
CMs are usually hired to
perform specialized work that the hiring company cannot
perform because of a lack of equipment, trained personnel,
or safety regulations.
CMs assist in the development,
manufacture, and marketing of high-quality products that
are delivered according to the customer’s timetable. This
allows customers to maintain a more stable financial
position while helping maintain cash flow. More and more
companies focus on outsourcing as a competitive strategy,
as opposed to a cost cutting or avoidance tactic.
CMs provide a “value-added”
service for certain materials or products.
Much of the value add of
working with a CM is attributed to having a product
manufactured in a certified facility where there is
assurance that the guidelines are being followed.
Contract manufacturers can
offer a diverse portfolio of medical device production and
testing experience. They also should have the appropriate
certifications and on-going processes to support Device
History Record (DHR) Documentation and/or compliance for
CE mark of medical devices.
Quality Management - medical
device contract manufacturer partners should be ISO
13485:2012 certified and cGMP compliant as well as provide
device documentation processes to support traceability
within Design History File (DHF), Electronic Medical
Device Reporting (eMDR), and Global Unique Device
Identification Database (GUIDID) requirements.
Design Engineering &
Development – good contract manufacturers exclusively
support FDA medical devices and provide full service
design engineering, device development, prototyping, and
production support that can also maximize Design for
Manufacturability (DFM) and speed-to-market efficiencies.
Another important factor for
regullstory compliance for a contract manufacturer is
whether the company is compliant to c-GMP (Current Good
Manufacturers must implement
and follow quality systems to assist in ensuring their
products consistently meet applicable requirements and
Good Manufacturing Practices
are guidelines that provide a system of processes,
procedures and documentation to ensure that the
manufactured products have the identity, durability,
composition, quality, and purity that they are said to
Although a manufacturer may be
assembling a medical product for which c-GMP requirements
are not applicable, this does not excuse the manufacturer
from maintaining complaint files or from general
requirements concerning records. It is important that CM
needs quality management system.
It is imperative to know how
to support in handling Customer Complaints and CAPA
(Corrective and Preventive Action). For a customer, it is
important that the CM handles complaints or comments. CM
needs to respond quickly to any issues. They also need to
correct problems immediately, and install processes to
prevent future problems. Monitoring of such processes
effectively is a requirement.
Depending on the project or
portion of a project that is outsourced, additional
requirements for the manufacturing partner to satisfy FDA
certification, the availability of clean-room facilities,
or the ability to handle continuous product updates may be
Apart from direct regulatory
compliance CM should know not to carry out inappropriate
changes, this can give rise to significant regulatory
risks to the purchaser. Some changes could trigger the
need for a PMA supplement or new 510(k) notice or going to
Notified Body with Design Change file.
Some changes could have
adverse effects on the product, putting patients at risk,
thus current risk assessment is a requirement.
Even the familiar requirement
that basically says the manufacturer "shall comply with
all QSR requirements" should not be enough. From the
manufacturer's perspective, this phrase is unrealistic.
Complete compliance with the QSR may be the Holy Grail,
but it is virtually unattainable: with enough searching,
some QSR deviations can be found in any facility. However,
the deviations can vary greatly in significance, from a
calibration test per formed a week late to an un-validated
To sum up, they should or
preferably to have regulatory compliances like:
21 CFR Part 820 – Quality
System Regulation Compliant
ISO 9001:2008 Registered
ISO 13485:2003 Registered
CE Marking Capabilities
Capable of obtaining various
Foreign Government Regulatory clearance/approval