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
New Content From Our Resource Library:
ISO 10993 and Biocompatibility for Medical Devices
NEW White paper: ISO 10993 and Biocompatibility for Medical Devices
Does your mobile app need FDA clearance?
NEW White paper: Does your mobile app need FDA clearance?
ISO 13485: An Overview for medical device companies
NEW White paper: ISO 13485: An overview for medical device companies
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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