Commercial Information Circulars
24-hour hotline : 23 922 922
e-mail address : enquiry@tid.gov.hk
Ref : EIC 411/2
30 August 2013
Dear Sirs,
Commercial Information Circular No. 702/2013
Argentina : Technical Regulations on Good Manufacturing Practice for Medical Devices and In Vitro Diagnostic Devices
The Southern Common Market (MERCOSUR) 1 issued a Mercosur Resolution No. 20/2011 in November 2011 regarding the technical regulations on good manufacturing practice (GMP) for methods and controls used in the design, procurement, manufacture, packaging, labelling, storage, distribution, installation and technical assistance of medical devices and in vitro diagnostic devices. The Argentine government issued Decree No. 3266/2013 on 7 June 2013 to incorporate Mercosur Resolution No. 20/2011 into its national legislation.
2. The technical regulations on GMP include provisions on general requirements of quality systems, quality documents and records, design control and product master record, processing and production controls, handling, storage, distribution and traceability, remedial and preventive actions, installation and technical assistance, and technical statistics.
3. For details, traders are advised to consult their importers in Argentina and/or the Argentine Decree (in Spanish), which is available at: http://www.infoleg.gob.ar/infolegInternet/anexos/215000-219999/216083/norma.htm.
ENQUIRIES
4.For enquiries about the content of this circular, please contact Miss S Y TANG at telephone number 2398 5405.
Yours faithfully,
(Ms Cindy CHENG)
for Director-General of Trade and Industry
| Note: | While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same. |