Agent Import of Class I and Class II Medical Devices
Importing medical devices is not just an exchange of goods, but also a strict assessment of regulations, standards, and safety. Here, we will dissect the import process of medical devices and common issues.
In Canada, the market access of medical devices is strictly regulated. In addition to meeting the requirements of the Food and Drugs Act and the Medical Devices Regulations, it also involves the classification of medical devices, license requirements, labeling regulations, and restrictions on illegal marketing.
According to relevant regulations from China Customs and the National Medical Products Administration, the declaration requirements and verification rules for the online verification of regulatory certificates for imported medical devices have recently been optimized and upgraded. This article details the definition, classification, and certification requirements of medical devices, as well as the declaration process and considerations for importing medical devices.
This article provides an in-depth exploration of the Indonesian medical device market, covering regulatory authorities, medical device classification, market registration processes, registration document requirements, and labeling regulations, aiming to offer reference and guidance for Chinese medical device companies to successfully enter the Indonesian market.
This article provides a detailed analysis of the certifications and procedures required for exporting medical devices to India, including the regulatory authorities for medical devices in India, the classification of medical devices, the application for a manufacturing license for medical devices exported to India, the regulations on medical device labels, and the specific steps of the process for exporting medical devices to India.
This article introduces in detail the key links of market access for medical devices in Thailand, including regulatory agencies, product classification, registration processes, and post - regulatory aspects. This information provides an important reference for Chinese medical device manufacturers to enter the Thai market.
In the global medical device market, Chinese manufacturers have achieved an important position in many fields. And the United States, as one of the largest medical device markets in the world, is undoubtedly an important target of concern for Chinese manufacturers. So, how do Chinese medical devices enter the US market? This article will analyze the entire process of Chinese medical devices being exported to the US in a process - oriented manner.
Rigid Gas Permeable (RGP) contact lenses, also known as OK lenses, are specially designed high - oxygen - permeable lenses. After wearing them for a period of time, the hydraulic pressure formed by the tear fluid between the lens and the cornea can change the shape of the cornea and temporarily reduce myopia. For Rigid Gas Permeable (RGP) contact lenses, the following are the applicable inspection standards, import document review requirements, and standardized declaration requirements:
The market access process for medical devices in South Korea is relatively complex, involving multiple steps and the participation of multiple departments. This article will briefly introduce the certification and registration processes required for exporting medical devices to South Korea.
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PSB Record: Shanghai No.31011502009912
