Medical devices defined in Vietnam are defined as all equipment, tools, materials and chemicals, and software that aim to provide disease testing and treatment and prevention, examination, diagnosis or mitigation, or replacement, modification or surgical assistance during examination and treatment. The classification of medical devices in Vietnam is divided into four categories, Class A, B, C, D..

In order to sell medical devices to Korea, there is a manufacturer in Korea or an overseas manufacturer needs a local agent. JNM Korea provide local agent service to help import to Korea. For the import, JNM Korea provides the following services as a local agent. KGMP certification in Korea - We provide customized services so that you can build a quality system. Import item permit / certificatio..

The Center for Device Regulation, Radiation Health and Research (CDRRHR) of the Philippines FDA has announced that the deadline for Certificate of Medical Device Notification (CMDN) applications for non-Notified Class B, C and D Medical Devices will be extended to March 31, 2024. . (FDA Circular No. 2021-002) In the meantime, these devices may be imported and sold on the Philippines market by an..

Guidelines for eSTAR submissions updated on March 29, 2023. The eSTAR is a PDF form for the process of preparing a medical device submission. This template contains: - Automation (for example, form construction and autofill) - Content and structure that is complementary to CDRH internal review templates - Integration of multiple resources (for example, guidances and databases) - Guided construct..

Guidelines for eSTAR submissions updated on March 29, 2023. The eSTAR is a PDF form for the process of preparing a medical device submission. This template contains: Automation (for example, form construction and autofill) Content and structure that is complementary to CDRH internal review templates Integration of multiple resources (for example, guidances and databases) Guided construction for ..

The Central Drug Standard Control Organization (CDSCO) is the National Regulatory Authority (NRA) of India. With effect from 1st January 2021, All the X-ray machines fall under the category of mandatory registration of CDSCO Medical Devices. The X-Ray device is classified as a Class C medical device as per the Risk-based classification of the Medical Device Rules, 2017. CDSCO has set up differen..

eSTAR electronic Submission Template And Resource In order to export medical devices to the U.S., devices and facilities shall be registered through propriate procedures for the FDA . Most FDA submissions are made through eCopy, and the FDA has published eSubmission guidelines through eSTAR to reduce unnecessary lead times arising from post submission. ​ In the case of documents submitted throug..