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​​產品應用領域

區域性規範

Canadian Standards

The Standards Council of Canada (SCC), representing Canada as a member of the International Organization for Standardization (ISO), directs the country’s involvement in the ISO 9000 family of quality system management standards. The SCC also participates in international agreements intended to ensure foreign acknowledgement of Canadian management system certification. While Canadian quality standards do not provide conformity assessments, they are applied to the accreditation of certification bodies that conduct third-party assessments. Canadian quality standards are intended to support regulatory guidelines, ensure the safety of products sold to Canadian consumers, and help Canadian companies enrich their competitiveness throughout the world.

EU Annex 11

Different regulations specifying compliance standards for electronic quality systems apply to different regions of the world. Just as FDA 21 CFR Part 11 institutes compliance standards for ensuring the integrity of electronic records and data for the United States, EU Annex 11 applies similar standards to the European Union as well as to any foreign manufacturers that are seeking EU market approval. Unlike Part 11, however, Annex 11 is a recommended guideline and not a legal requirement. The scope of Annex 11 relates to good manufacturing practices (GMP) for medicinal products intended for human use, investigational medicinal products for human use and veterinary medicinal products.

PMDL (Japan)

Japan’s medical device market authorization process has historically been considered one of the lengthiest and most rigorous in the world. Presently, even though regulations are still stringent, the Pharmaceutical and Medical Device Law (PMDL) that went into effect in November 2014 is intended to streamline Japanese regulatory requirements for medical devices. The PMDL replaces the Pharmaceutical Affairs Law (PAL), the prior mandate for medical device registration requirements in Japan. The goal of the PMDL is to make the process even faster than that of the U.S. FDA. Quick access to safe and effective medical devices and diagnostics is of particular importance since Japan represents the second largest market for medical technology products in the world.

PIC/S

PIC/S is an acronym used to describe two groups operating in parallel in the GMP (Good Manufacturing Practice) field: the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme). The PIC Scheme is a cooperative arrangement between the health authorities of various nations that seeks to continue and enhance the work of PIC, which is a formal treaty and has legal status. Since PIC/S standards are now applicable to Japanese markets, many pharmaceutical companies that serve those markets are turning to electronic quality management solutions like MasterControl to maintain PIC/S compliance.