Medical Device Good Distribution Practice

Medical Devices

The following provides regulatory information on the medical device good distribution practices (MDGDP) in various jurisdiction.

US

NOTE: Under 21 CFR 801.01, it provides the definition of Unique Device Identifier as follows.

Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of 830.20 of this chapter. A unique device identifier is composed of:

(1) A device identifier –a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and

(2) A production identifier –a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device:

(i) The lot or batch within which a device was manufactured;

(ii) The serial number of a specific device;

(iii) The expiration date of a specific device;

(iv) The date a specific device was manufactured;

(v) For an HCT/P regulated as a device, the distinct identification code required by 1271.290(c) of this chapter.

EU

China/Hong Kong

About this Reference Manual Hong Kong Medical and Healthcare Device Industries Association and the Hong Kong Productivity Council have completed a project through the funding of the “SME Development Fund” by the Trade and Industry Department. This project aims at enhancing the competitiveness of Hong Kong’s SMEs in medical and healthcare device industry through upgrade of their distribution operations.

Singapore

Drugs

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Last Updated: 2015-10-02