Brazil Mulls Foreign GMP Certificates
Brazil’s Anvisa is weighing the benefits of recognizing international good manufacturing practice certificates from devicemakers seeking to register products in the country. By accepting audits and inspections from “peer” regulators, Anvisa could potentially reduce its annual inspection workload by 70 percent and ease the registration process for foreign manufacturers, the agency said. Anvisa currently conducts about 600 overseas inspections a year. . . .
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Elevation of China, Korea Device Agencies Not Expected to Have Major Impact
Last month's reorganizations of the medical device authorities in China and South Korea were fueled largely by food safety concerns and should have little impact on device policy, experts say. On March 22, China upgraded its State Food and Drug Administration to ministry level, changing the name to the China Food and Drug Administration (CFDA). Korea followed suit on March 25, promoting the Korea Food and Drug Administration to the Ministry of Food and Drug Safety (MFDS). Both agencies are now more closely modeled on the U.S. Food and Drug Administration, sources say. . . .
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Major Changes to India's Device Regulations Unlikely in 2013
Devicemakers should expect no major shakeup in India's requirements for medical devices in 2013, and possibly not in 2014, despite draft legislation aimed at establishing comprehensive regulations for the industry, an expert says. When a regulatory framework for devices is approved, companies will have ample time to comply, predicted Bryan Gilburg, vice president of business development at the Emergo Group. . . .
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New Zealand, EU Agree to Recognize Conformity Assessments, GMP Audits
Devicemakers doing business in both the EU and New Zealand can expect fewer conformity assessment reviews and quality assurance inspections, thanks to a mutual recognition agreement between regulators in the two jurisdictions. The agreement -- which also allows for the exchange of inspection information -- comes as New Zealand is merging its Medsafe agency with Australia's Therapeutic Goods Administration. Devices intended for use in clinical trials are included under the agreement, though it does not currently cover in vitro diagnostic devices. . . .
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Singapore Draft Guidance: Audit Suppliers to Check QMS Compliance
Manufacturers of lower-risk Class A devices should conduct regular reviews of their quality processes and those of their suppliers to ensure compliance with licensing and/or regulatory requirements, according to new draft guidance from Singapore's Health Sciences Authority (HSA). Companies should document the outcome of the review, any observations made and corrective actions, the guidance states. It specifies quality requirements for the import and wholesale dealing of low-risk devices. Devicemakers are responsible for ensuring that outsourced processes within the scope of the quality management system (QMS) are compliant, the HSA said. . . .
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U.S, Canada, Japan and Brazil Agree To Single Device Quality Audit Program
The U.S. Food and Drug Administration (FDA) Nov. 27 signed a statement of cooperation with Brazil’s Anvisa, Australia’s Therapeutic Goods Administration and Health Canada to create a single audit program for device quality management systems (QMS). The agreement will enable the pooling of technology, resources and services to make the device oversight more efficient, the statement says. . . .
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Pakistani Law Aims to Stanch Supply Of Counterfeit Medical Products
Pakistani President Asif Ali Zardari last month signed legislation to ensure the safety of medical products and criminalize the import, export or sale of fake or substandard products. The new law, published in the official gazette,creates a comprehensive regulatory framework for drugs, biologics and medical devices and a Drug Regulatory Authority of Pakistan (DRAP) comprised of a CEO and seven full-time department heads. Those departments will be responsible for registration, licensing and quality control, biologicals and medical devices, pharmacy services, traditional medicines, pricing, and administration and legal affairs. The CEO will serve three years, with the prospect of a second term, and must have a postgraduate degree in pharmacy, public health or medicine plus 20 years of experience. . . .
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South Korea: Foreign Devicemakers Face Premarket, Import Controls
New South Korean requirements for medical devices introduced this year have made the country's strict regulation of foreign devicemakers even more rigorous, an expert says. One of the requirements -- notification no. 2011-82 -- calls for a safety and efficacy report and more stringent review of any device that does not have an equivalent in the Korean market, Brian Gilburg, vice president of business development at Emergo Group, said in a recent webinar. Substantial equivalence requirements previously applied only to newer, high-risk devices. . . .
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What is ISO 13485?
International Organization for Standardization (ISO) 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. . . .
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