Wednesday, September 9, 2009

What is the Definitions of the Terms Manufacturer, Authorised Representative, Distributor and Importer?

As per GHTF find below the guide to know the definitions of Definitions of the Terms Manufacturer, Authorised Representative, Distributor and Importer.

1.1 Manufacturer
“Manufacturer” means any natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s).

1. This ‘natural or legal person’ has ultimate legal responsibility for ensuring compliance with all applicable regulatory requirements for the medical device in the countries or jurisdictions where it is intended to be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory Authority (RA) within that jurisdiction.
2. The manufacturer’s responsibilities are described in other GHTF guidance documents. These responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse event reporting and notification of corrective actions.
3. ‘Design and/or manufacture’, as referred to in the above definition, may include specification development, production, fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for a medical purpose.
4. Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation does not change the intended use of the medical device.
5. Any person who changes the intended use of, or modifies, a medical device without acting on behalf of the original manufacturer and who makes it available for use under his own name, should be considered the manufacturer of the modified medical device.
6. An authorised representative, distributor or importer who only adds its own address and contact details to the medical device or the packaging, without covering or changing the existing labelling, is not considered a manufacturer.
7. To the extent that an accessory is subject to the regulatory requirements of a medical device, the person responsible for the design and/or manufacture of that accessory is considered to be a manufacturer.
1.2 Authorised Representative
“Authorised representative” means any natural or legal person established within a country or jurisdiction who has received a written mandate from the manufacturer to act on his behalf for specified tasks with regard to the latter’s obligations under that country or jurisdiction’s legislation.
1.3 Distributor
“Distributor” means any natural or legal person in the supply chain who, on his own behalf, furthers the availability of a medical device to the end user.
1. More than one distributor may be involved in the supply chain.
2. Persons in the supply chain involved in activities such as storage and transport on behalf of the manufacturer, importer or distributor, are not distributors under this definition.
1.4 Importer
“Importer” means any natural or legal person in the supply chain who is the first in a supply chain to make a medical device, manufactured in another country or jurisdiction, available in the country or jurisdiction where it is to be marketed.

Guidance document on the management of design and process changes

To ensure that good quality assurance practices are used for the design of medical devices and that they are consistent with quality system requirements worldwide, the Food and Drug Administration revised the Current Good Manufacturing Practice (CGMP) requirements by incorporating them into the Quality System Regulation, 21 CFR Part 820. An important component of the revision is the addition of design controls.
Because design controls must apply to a wide variety of devices, the regulation does not prescribe the practices that must be used. Instead, it establishes a framework that manufacturers must use when developing and implementing design controls. The framework provides manufacturers with the flexibility needed to develop design controls that both comply with the regulation and are most appropriate for their own design and development processes.
This guidance is intended to assist manufacturers in understanding the intent of the regulation. Design controls are based upon quality assurance and engineering principles. This guidance complements the regulation by describing its intent from a technical perspective using practical terms and examples.
You can download the guidance here - Design Control Guidance For Medical Device Manufacturers

In the last GHTF STEERING COMMITTEE MEETING last October a discussion started regarding the potential need for a guidance document on the management of design and process changes . It was decided that there is no consolidated approach to how changes are assessed by the regulatory jurisdictions. Hence in coming days the user group 1 of the GHTF is assigned to create the guidance document.

Medical Device Supply Chain - Managing the long chain as per FDA regulations

with the recession looming large on all businesses Medical device Manufacturers are focussing more on outsourcing the manufacturing and services function to low cost destinations. But with the benefit of low cost also comes lots of problems related to regulations and management. As the supply chain becomes longer and more diverse it becomes more difficult to control. But the company is reponsible for any kind of problem happening with the devices and ultimately will be held responsible for its failure. Hence it is very important to have a concrete process for the supplier selection, evaluation and management. The FDA has formulated many regulations for medical devices that define the requirements for supplier selection, management, and control. ISO 13485 includes similar requirements. In February 2009, the Global Harmonization Task Force (GHTF) released a guidance document on controlling products and services from suppliers. This guidance document has become the global de facto standard for supplier management.

As part of their Quality Management System (QMS) requirements, manufacturers must evaluate, select, and monitor suppliers. As the supply chain becomes longer and more diverse, the methods of control become more difficult and the expectations of regulators become more stringent.

The best approach implements specific actions:
· Create clear requirements for supplier
· Evaluate potential suppliers against the criteria
· Create cross-functional multi-discipline teams that remain active beyond the selection process
The team approach, often called a commodity team or supplier team, is one of the most effective methods for supplier selection and management. The team needs to understand the requirements, implement the best practices in the GHTF document, and work with suppliers.

There is a webinar on this conducted by Complianceonline in Oct 30. Click on the link below to view the complete agenda.

Download the GHTF Document -
Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers