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Legal Basis and Authorities
According to notifications from World Trade Organization (WTO), several resolutions for medical devices are proposed to enter into force with the earliest start being on May 2, 2022, by the Brazilian Health Regulatory Agency. Earlier in March 2022, B
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*Disclaimer: This webinar will be given in Mandarin
The new European Medical Device Regulation (MDR, EU 2017/745) replaced the Medical Devices Directive (MDD, 93/42/EEC) and Active Implantable Medical Devices Directive (AIMDD, 90/385/EEC) implemen
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Overview
The regulation of medical devices is primarily concerned with enabling patient access to high quality, safe and effective medical devices, and avoiding access to products that are unsafe. WHO has a mandate, as outlined in the World Health Assembly (W
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Legal Basis and Authorities
The European Medical Devices Regulation (MDR) replaced the previous Medical Device Directive (MEDDEV), which was lagging the current state of the art. The MDR will be:
Introduced progressively
Updated regularly by means of Implementi
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Legal basis and the Authorities
In India medical device are governed by CDSCO (Central Drugs Standard Control Organization) which is regulated by Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. Many committees have been set up and
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Overview
India’s Central Drug Standard Control Organisation (CDSCO) has Central Licensing Authority (CLA) and State Licensing Authority (SLA) with responsibility for Licensing to Import, Manufacture for sale or for distribution and sale, stock, exhibit
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Standards
China has National Standard for medical devices. Any medical device must follow the Chinese National Standard Specifications. More than 35% of all the IEC and ISO standards have now been adopted by China, but many are not direct transpositions and co
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Registration Process
The chemical substances that are sold in the market must be registered in the Russian Federation. The requirement of the registration is mandatory for the main legal act in the field of environmental protection that is “On Protection of the E
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International Conventions
International effort in addressing POPs starts in the late 1990s. The initial protocol to address POPs was implemented in 1998, signing 16 chemicals to phase out according to previously established risk criteria. The Aarhus Protocol also impose parti
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International Regulation
International effort in addressing POPs starts in late 1990s. The initial protocol to address POPs was implemented in 1998, signing 16 chemicals to phase out according to previously established risk criteria. The Aarhus Protocol also impose parties t
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International Regulations
International effort in addressing POPs starts in the late 1990s. The initial protocol to address POPs was implemented in 1998, signing 16 chemicals to phase out according to previously established risk criteria. The Aarhus Protocol also impose parti
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China Regulation
China signed the Stockholm Convention on its launch in 2001 and ratified the Convention in 2004. Since then, the initial list of 12 POPs listed in the Stockholm Convention entered the government agenda. For example, the Regulation for Pesticide Manag
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Global Product Compliance (GPC) specializes in Global Regulatory Compliance Solutions across sectors
globally. SSS Europe, a familiar name in chemical regulatory and compliance services now formally belongs
under the umbrella of GPC Holding Sweden.
Since 2008, we have emerged as one of the leading names among Global Regulatory Compliance Service
Providers with Representation services in Europe, Asia and Middle East for respective chemical
regulations.
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