In our latest edition, we cover news that Indian regulators intend to formally distinguish medical devices from drugs in order to more clearly regulate them. Developments in Brazil and the US are also included. For regular updates on medical device markets worldwide, visit our QA/RA blog.
| Indian Regulators to Formally Separate Medical Device and Pharmaceutical Rules The Indian Ministry of Health and Family Welfare has issued draft rules that establish registration and quality system requirements for medical devices and IVDs distinct from … READ FULL STORY |
| Lawsuit in Brazil Allows Some Manufacturers to Pay Reduced ANVISA Fees Sooner Following a successful legal case against the Brazilian government, some medical device manufacturers may now pay reduced registration and quality system inspection fees without having to request refunds from the country’s … READ FULL STORY |
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| US FDA Centralizes Effort to Address Combination Product Issues US medical device and pharmaceutical regulators are launching a new committee to more comprehensively address policy and implementation challenges associated with combination … READ FULL STORY |
| Brazil Updates Label Requirements for Wireless Products The Agencia Nacional de Telecomunicacoes (ANATEL) in Brazil has updated its labeling regulations for wireless products, including some medical devices … READ FULL STORY |
| Spotlight On India Emergo consultants in our New Delhi office can provide the expertise and resources to support medical device companies as they commercialize and distribute their products in the Indian market. Our services and resources for India include: |
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Jack Slovick President Methodize Inc P.O. Box 463 Nevis, MN 56467 763.639.0238 (cell) www.methodizeinc.com