China Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices - Customs Forum

**admin** · 07-22-2011, 00:36 AM

General Market Condition: In transition from Prohibited to Restricted
In early 1998 China barred the importation of a wide range of electro-mechanical devices (including many medical devices). Early in 2003, China issued a decree, “Administrative Measures on Product Inspection and Supervision of Imported Used Mechanical and Electrical Products,” which would lift the 1998 ban. Implementation of the new decree, originally set for 1 May 2003, has been postponed until 1 August 2003. Implementation of the decree for medical devices may be even further off according to conversations held between the US Commercial Service in Beijing and Chinese health officials.
Under the new decree, many used products, including used medical devices, will be subject to a pre-shipment inspection and an arrival inspection. Although a second decree was issued in late April 2003 discussing which items will be subject to the pre-shipment inspections, many details about the standards and inspection procedures have yet to be issued. Officials with the Department of Medical Devices of China's State Food and Drug Administration (SFDA) have told US Commercial Service staff that the ban on importing used medical devices will not be lifted until the standards for testing and administrative guidelines for used medical devices are in place. SFDA is studying this issue and, after their study is completed, SDA will set up registration procedures for used medical devices with testing standards and administrative guidelines. No timetable has been given for the reopening of the market for used medical devices, but there is speculation that it might happen in 2004.
Summary
The January 8 International Business Daily published a notice jointly issued by four ministries and commissions tightening control over the import of used machinery and electric products.
Text
From January 1, 1998, except for special needs with the approval of the State Machinery and Electric Products Import and Export Office, all import of used machinery and electric products are forbidden, regardless of the source of foreign exchange, means of trade, and import channels.
Without approval, units with the right of foreign trade are not allowed to sign contracts or binding agreements for the import of used machinery and electric products.
Foreign exchange administration agencies and banks pay or sell foreign exchange upon presentation of the 'Quota Products Certificate' issued by the State Machinery and Electric Products Import and Export Office, the 'Certificate of Machinery and Electric Products Import,' or the 'Registration Form of Machinery and Electric Products Import.'
The customs office inspects and approves import of used machinery and electric products upon presentation of the 'Certificate of Quota Product,' 'Certificate of Machinery and Electric Product,' 'Import Registration Form of Machinery and Electric Products,' and 'Import Certificate' issued by the State Machinery and Electric Products Import and Export Office and the Ministry of Foreign Trade and Economic Cooperation with a used product note, and the 'Memorandum of the Import of Used Machinery and Electric Product' issued by the State Administration of Import and Export Commodity Inspection.' Violators will be subject to treatment of relevant regulations.
Commodity Inspection Agencies conduct inspections on all the used machinery and electric products approved by the government. The Commodity Inspection Agencies issue 'Notice of Conditions of Import Commodity Inspection' for the used machinery and electric products that conform to the state safety and environmental protection enforced criteria and the inspection criteria as stated in the contract. Unqualified products will be subject to treatment according to relevant regulations of commodity inspection.
Use of import documents for new machinery and electric products to clear used machinery and electric products through customs is strictly forbidden. If discovered, the products will be confiscated by Customs. The customs tariff or other taxes and fees are to be charged based on 60 percent of value of the new product.
Comment
The January 7 People's Daily , published the notice in part, and mentioned the following products: used liquid pressure bulldozers, diesel engines for ship use, CT for medical use, and X-ray diagnostic instruments for medical use.

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