Navigating the Regulatory landscape for medical device registration in China can be a complex process, especially for foreign manufacturers. One of the most critical steps in ensuring compliance with Chinese Regulatory requirements is the appointment of a China agent. This blog will provide a comprehensive guide on why you need a China agent, their key responsibilities, and the process of appointing them for medical device registration in China.

The Guidelines for Registration Review of Radio Frequency (RF) beauty devices in China is a consolidated document that guides registration applicants and technical review departments on how to prepare registration application materials for RF beauty devices.

These guidelines are meant specifically for RF beauty devices, which include devices used for skin treatment, fat reduction, and other cosmetic purposes; such devices use high-frequency current to act on the human body.

Complaint handling is an integral part of medical device companies’ Quality Management System (QMS). It involves receiving, investigating, and resolving customer complaints related to medical device products and services provided by an organization. Such complaints are related to the safety, performance, or effectiveness of medical devices, as per ISO 13485. Companies must address complaints promptly and effectively to maintain customer satisfaction and uphold Regulatory compliance.

The previous blog on the Fast-break Scheme (Part 1) discussed Japan’s conditional early approval system for innovative medical devices, covering four (04) essential steps, the rationale and requirements for the application review process, the eligibility criteria, the application submission process, the MHLW and PMDA’s Regulatory guidelines, the review process, eligibility without pre-development consultation, and the key considerations for describing eligibility summaries.

Literature reviews play a crucial role in the clinical evaluation of medical devices and In Vitro Diagnostics (IVDs) throughout their entire lifecycle. These reviews enable researchers to examine previous studies, build upon existing knowledge, and contribute meaningfully to their respective fields. However, adhering to traditional approaches in a literature review can be time-consuming and arduous, particularly considering the evolving needs and demands of the medical field. This can lead to missed opportunities and incomplete analysis.

The General Data Protection Regulation (GDPR) is a comprehensive privacy law enacted in the European Union in 2018. It applies to all organizations that process the personal data of individuals located in the EU, regardless of where the organization is located.

The Brazilian Health Regulatory Agency, ANVISA, issued Resolution RDC 751, which recently specified the standards and guidelines for the notification, registration, post-approval modifications, and revalidation of medical devices in Brazil. ANVISA’s Resolution of the Board of Directors (RBD) No. 751/2022 was recently published and has been effective from March 01, 2023.

Thanks to the rapid development of vaccines and quick vaccinations in major parts of the world, there seem positive developments in all the business sectors towards the growth. However, the threat is persisting in terms of new waves and new variants of COVID. Let us hope we soon get over this and see the brighter side of the business. Even in these darkest times of humankind, few business sectors like Life Sciences are recording good business growth and taking quick strides forward.

A Medical Device Establishment Licence (MDEL) is a license issued to Class I medical device manufacturers, importers, or distributors of all device classes. In a recent guidance, Health Canada described how the Agency inspected the licensed medical device establishments, the inspection process and explained how inspectors should assess the compliance with the Food and Drugs Act and Medical Device Regulations.

The Indian medical device industry is amongst the top 20 markets worldwide and considered as one of the fastest growing. Since approximately 80% of the Indian medical device needs are met through imports, it is essential to have a strong medical devices regulatory regime. The Indian regulatory agency, the CDSCO, make a conscious effort to improve their regulations to release safe and efficient medical devices into the market.