MEDICAL DEVICE INTERNATIONAL

Dillard, S.F. and MacCollum, M.A., Reports to FDA allergic reactions to latex containing medical devices, International Latex Conference Sensitivity to Latex in Medical Devices, 1992, 23 (abstract). 

Issakov, A., Health Care Equipment A WHO Perspective, in Medical Devices International Perspective on Health and Safety, edited by C. W. G. Von Grutting, Elsevier, Amsterdam, 1994, pp. 48-53. 

Abreu M J, Cabe90 Silva M E, Schacher L, Adolphe D (2003), New Performance and Quality Requirements in the Field of Operating Room Garments (Non-Active Medical Devices) . International Journal of Health Care Quality Assurance, 16(5), 261-264. 

Jetley, R., Garlos, G., Purushothaman Iyer, S. A case study on applying formal methods to medical devices. International Journal on Software Tools for Technology Transfer 5(4), 32(U330 (2004)... 

The pressure equipment directive was adopted by the European Parliament and the European Council in May 1997. It harmonises the national laws of the 15 Member States of the European Union relating to equipment subject to the pressure risk. That directive is one of the series of technical harmonisation directives such as for machinery, medical devices, simple pressure vessels, gas appliances and so on, which were foreseen by the Communities programme for the elimination of technical barriers to trade. It therefore aims to ensure the free placing on the market and putting into service of the equipment concerned within the European Union and the European Economic Area. At the same time it permits a flexible regulatory environment, allowing European industry to develop new techniques increasing thereby its international competitiveness. 

Only three countries, Tunisia, Uganda and Zimbabwe, do not issue a GMP certificate. The drug regulatory authorities in these three countries do conduct GMP inspections, but do not issue a specific document which indicates that a manufacturing plant has attained GMP standards. The MCAZ does, however, provide a GMP certificate at the manufacturer s request to facilitate international registration and export of products. In Malaysia, various types of certificates are issued GMP certificates Certificate of Pharmaceutical Product for export and Certificate of Free Sale for medical devices and cosmetic products. Cyprus has no clear criteria for issuing a GMP certificate instead. 

Biological evaluation of medical devices—Part 5 Tests for cytotoxicity in vitro methods. ISO 10993-5 1992(E). International Standards Organization, 1992. 

Where there is a dosing device provided with the product, the dose reproducibility and accuracy should be demonstrated. Examples include dropper devices, dose-measuring devices, and pen injectors. The instructions for use should also be discussed for such devices and may be particularly important for devices such as two-chamber cartridges and the like containing suspension products. It might be necessary to discuss how dosing devices meet the relevant Essential Requirements of the Medical Device Directives with reference to appropriate and relevant harmonized and other European (EN) and International Standards Organization (ISO) standards. 

Common biodegradable polymers for medical devices are constructed from synthetic linear aliphatic polyesters. One material commonly used for internal sutures is poly(glycolic acid) (PGA). PGA is synthesized from the dimer of glycolic acid (Fig. 13.1.l). 1... 

Medical Device Consultants International (Rapra Technology Ltd.)... 

International Organization for Standardization (ISO), Application of risk management of medical devices, ISO 14971 2000, ISO, Geneva. 

Since 1998, all medical devices marketed in Europe (EEA) must bear the CE mark, which signifies conformity to the essential requirements of the MDD. The MDD harmonized the European requirements along with device certification and the inspection procedures for manufacturers to ensure the highest degree of safety and product quality of the medical devices throughout the EC. Most important was the requirement for a full quality assurance system (Annex II of the MDD, 93/42/EEC), which included design controls for new medical device products. This was in line with the ISO 9000 series of standards established for quality systems by the International Organization for Standardization. 

Center for Devices and Radiological Health (CDRH), Guidance for Industry. Regulation of Medical Devices Background Information for International Officials, April 4,1999. 

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