What is RDC 16?

What is RDC 16?

RESOLUTION – RDC No.16 OF MARCH 28, 2013. Approves the Technical Regulation for Good Manufacturing Practices of Medical Devices and In Vitro Diagnostic Devices and gives other provisions.

Which devices need to be registered with ANVISA?

Class II-IV devices are subject to ANVISA review prior to approval. Class II devices are registered via the Cadastro route, while Class III and IV devices are registered via the more complex Registro route.

What is full form ANVISA?

The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian regulatory agency that is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices, among others.

What standard is MHLW Ordinance #169 like ISO?

Japanese medical device regulators coordinating ISO 13485:2016 and MHLW Ordinance No. 169 quality management system requirements.

How long does it take to register a medical device in Brazil?

Approval takes only 4-6 months for the cadastro process. For the registro process, an ANVISA audit is required, after which registration takes an additional 8-10 months. SPECIAL REQUIREMENTS: Audits: A GMP audit is mandatory for manufacturers of class III and IV devices, based on the Brazilian GMP regulations.

What’s the meaning of ANVISA?

The Brazilian Health Surveillance Agency, commonly known as ANVISA, abbreviated from Portuguese “Agencia Nacional de Vigilancia Sanitaria,” is the food and drug regulatory agency in Brazil. ANVISA was created in 1999 and is linked to the Ministry of Health.

What are two jurisdictions covered by Mdsap?

The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.

What is QMS in medical devices?

In simple terms, a medical device quality management system (QMS) is a structured system of procedures and processes covering all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and more.

What is CE marking for medical devices?

What is CE marking? CE marking is the medical device manufacturer’s claim that a product meets the General Safety and Performance Requirements (GSPR) of all relevant European Medical Device Regulations and is a legal requirement to place a device on the market in the European Union.

When did ANVISA issue resolution RDC 211 and RDC 212?

On January 23 2018, ANVISA issued Resolution RDC 211 and RDC 212/2018, which deal with the validity period of medical device registry, as well as with the procedures related to the renewal of product registration. According to the new legislation, the registries of medical devices and IVDs (risk classes III and IV) will have a…

What was resolution RDC 16 of March 28, 2013?

RESOLUTION – RDCNo.16 OF MARCH 28, 2013 Approves the Technical Regulation for Good Manufacturing Practices of Medical Devices and In Vitro Diagnostic Devices and gives other provisions.

When does ANVISA RDC 270 / 2019 come into force?

On March 1st, 2019, ANVISA published RDC 270 / 2019 in the Brazilian Official Gazette. The new legislation deals with the migration of the cadastro route to the notification route for Class I medical devices (materials, equipment and IVD products). RDC 270/2019 amends RDCs 36 and 40/2015 and shall enter into force as of May…

How to register a medical device with ANVISA?

ANVISA published a news article (link in Portuguese) on their website summarizing the changes and explaining how they differ from current regulations. Global Regulatory Partners Inc. (GRP), local team of regulatory experts can assist with the registration of your medical device or IVD with the Anvisa in Brazil.