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.

1 comment:

  1. I have to audit an API supplier who produces biotechnological products. Is there any FDA or EMEA guideline in addition to ICHQ7A for that kind of products?