Written question asked by Roger Gale (Conservative) on Thursday, 6 July 2006, in the House of Commons. It was due for an answer on Wednesday, 12 July 2006. It was answered by Baroness Winterton of Doncaster (Labour) on Thursday, 13 July 2006 on behalf of the Department of Health.

Dentistry

Question: To ask the Secretary of State for Health what steps the Medicines and Healthcare Products Regulatory Agency (a) is taking and (b) plans to take to monitor the quantity and quality of single-tooth dentures imported from countries outside the European Union.

Answer: [holding answer 12 July 2006]: The Medical Devices Regulations 2002 for which the Medicines and Healthcare products Regulatory Agency (MHRA) acts as the regulatory authority on behalf of the Secretary of State, does not regulate the quantity of dentures imported from countries outside the European Union. They do, though, contain requirements for the safety and fitness for purpose of custom-made dental appliances which all manufacturers, wherever they are based, should ensure are met before placing their dentures on the United Kingdom (UK) market. Where the manufacturer is based outside the European Community they are also required under the regulations to appoint an authorised representative to register on their behalf with the member state competent authority where they have their registered place of business. MHRA conducts an annual programme of inspections of custom made appliance manufacturers and authorised representatives based in the UK selected at random.

Secondary information