The Medical Device Master File (MFs) registration system is a key initiative. It provides an excellent pathway for global suppliers of raw materials, critical components, software, and manufacturing processes to protect their intellectual property and efficiently support their Chinese clients in completing product registration.

On October 16, 2025, the Shanghai Municipal Medical Products Administration, Shanghai Municipal Health Commission, and Shanghai Customs jointly issued the Shanghai Pilot Work Plan for Service Guidance on Temporary Import of Clinically Urgent Drugs and Medical Devices. 《上海市关于临床急需药械临时进口服务指导工作方案（试行）》This new plan aims to streamline the temporary import process for clinically urgent drugs and medical devices in Shanghai, helping patients gain faster access to innovative medical products.

중국NMPA 수입의료기기 등록

On October 23, 2025, CIRS Japan successfully hosted its First Anniversary Celebration & Global Chemical Regulation Seminar in Tokyo. This event, available both in person and virtually, gathered together experts from the Japan Environmental Management Association for Industry (JEMAI) and the Japan Chemical Exporters & Importers Association (JCEIA), and other authoritative institutions, as well as representatives from major international chemical companies, including Mitsubishi Chemical and Kao Corporation. The event was packed with insightful discussions and networking opportunities, showcasing CIRS Japan's local expertise and the global support from CIRS Group.

Polycarbonate (PC), as a biodegradable polymer material, has various application scenarios in the medical field. These include disposable ophthalmic surgical knives, ophthalmic trocars/cannulas, polymer materials and products for dentures, orthopedic core drill, auxiliary instruments for vertebroplasty, and ring-handle syringes. As a raw material for medical device products, PC can undergo Master File registration. This authorizes medical device registration applicants to reference it as part of their regulatory submission when applying for medical device registration.

On September 24, 2025, we were delighted to welcome over 100 attendees from 20 countries to the CIRS Global Chemical Regulations Conference. It was a day full of expert insights, lively discussions, and valuable networking, showcasing the global nature of the regulatory challenges and opportunities our industry faces. From start to finish, the energy in the room was clear: delegates connected with colleagues old and new, explored fresh ideas, and left with practical updates to support their work.

PPDO (Poly-p-dioxanone) is a class of aliphatic poly(ether-ester) polymers renowned for their excellent mechanical properties, biocompatibility, and biodegradability. As early as the last century, it was approved by the U.S. FDA for use in manufacturing Class III medical devices. It serves as a key material for producing absorbable sutures, cosmetic lifting threads, ligation clips, abdominal meshes for hernia repair, and other implantable devices. PPDO, along with its copolymers, blends, and composite materials, is also being developed for applications in bone repair, vascular stents, tissue adhesives, drug sustained-release carriers, and aesthetic products such as "ELLANSé" and "SCULPTRA".

The Medical Device Master File is a form of technical documentation submitted by its owner to the medical device technical review authority. It is used to authorize medical device registration applicants to reference it as part of their registration submission materials when applying for medical device registration. The Medical Device Master File system facilitates the selection of raw materials and key components by medical device manufacturers and simplify the registration and application process. Simultaneously, the principle of voluntariness and confidentiality for the master file registration effectively protect the intellectual property rights of the master file owner.

The Medical Device Master File is a form of technical documentation submitted by its owner to the medical device technical review authority. It is used to authorize medical device registration applicants to reference it as part of their registration submission materials when applying for medical device registration. As a raw material for medical device products, recombinant collagen is eligible for master file registration.

We are excited to announce a new strategic cooperation agreement between CIRS Europe and EPY S.R.L, an Italian software company specializing in regulatory compliance solutions. This partnership marks a significant step in enhancing regulatory support and digital solutions for businesses navigating complex compliance requirements.