The following provides regulatory information on the medical device good distribution practices (MDGDP) in various jurisdiction.
- 21 CFR Part 820
- 21 CFR Part 830
- FDA good importer practices
- FDA import and export guidance documents
- As for monitoring device-time, temperature and humidity. USP Chapter 1118
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.
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.
- 2013-09: China MDGDP Reference Manual
- US: Drug Supply Chain Security Act (DSCSA)
- FDA Guidance: Product Tracing Requirements for Dispensers
- UK and EMA from GOV.UK
- Ireland: HPRA Good Distribution Practice of Medicinal Practices
- USP 1083 Good Distribution Practices-Supply Chain Integrity
- WHO:Annex 5 WHO good distribution practices for pharmaceutical products
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Last Updated: 2015-10-02