Our 22nd Year of Publication
Page  5 of 5

Cover Story

Regulatory Issues In Contract Manufacturing (Out Sourcing) Of Medical Devices

Mr. Sanjay Shah
Unikal Consultants

Medical 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.

Thus 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.

Looking 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.

Definitions of Establishment Activities as per FDA

Contract Manufacturer - Manufactures a finished device to another establishment's specifications.

Contract Sterilizer - Provides a sterilization service for another establishment's devices.

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 productivity manufacturing.

Organization’s financial objectives result in the consideration of reducing company overhead, including facility costs or a reduction in labour costs.

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 house.

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.

Regulatory Requirements

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 Manufacturing Practices).

Manufacturers must implement and follow quality systems to assist in ensuring their products consistently meet applicable requirements and specifications.

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 possess.

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 necessary.

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 manufacturing process.

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

Page  1  :  2  :  3  :  4  :  5

Back | Back to Top | Previous