More and more new guidelines are published according to the Regulations on Supervision and Administration of Medical devices (Order 739), the Administrative Measures for Registration and Filing of Medical Devices (Order 47) and the Administrative Measures for Registration and Filing of IVD (Order 48). Since Jan 1, 2022, new requirements for medical device/IVD registration application dossiers will be effective. more…
Fundamental of Type Testing
Type testing, also known as medical device registration testing, is a mandatory requirement by the National Medical Product Administration (NMPA), the equivalency of the FDA in China, for market approval of medical devices. more…
Ministry of Finance:Government procurement should treat foreign-funded enterprises equally
Recently, the Ministry of Finance issued the notice on implementing the relevant policies on equal treatment of domestic and foreign-funded enterprises in government procurement activities (hereinafter referred to as the notice). more…
Recently, NMPA issued an announcement on the implementation of the second batch of Unique Device Identification (UDI) of medical devices (Order 114 of 2021). From January 1, 2021, the first batch of 69 medical device varieties in 9 categories were required to have UDI. Regarding the second batch of UDI, detailed information can be found as below: more…
The Provisions for Medical Device Registration and Filing and the Provisions for In-vitro Diagnostic Reagent Registration and Filing have been issued and shall come into force as of October 1, 2021. For better implementation of the provisions, relevant matters are announced as follows: more…
On September 28, 2021, NMPA issued a notice of five technical guidelines including Technical Guidelines for Clinical Evaluation of Medical Devices. The guidelines are the guidance for the applicants and reviewers. It doesn’t involves the administrative matters as review and approval for registration. Applicants should determine whether the contents are applicable based on the specific characteristics of the product. If not applicable, the reasons and corresponding scientific basis should be described in detail. Other methods complying with requirements of laws and regulations can also be adopted, but detailed research and verification data shall be provided. more…
In order to help and guide the registration applicant to prepare the application materials of registered products to meet the basic requirements of technical review, CMDE of NMPA recently issued two drafts for comments online. They are the Guideline for Registration and Review of Disposable Abdominal Puncture Device (Draft) and the Guideline for Special Registration and Review of Digital Technology of Positron Emission / X-ray Computed Tomography System (Draft). The comments should be submitted by October 21 and October 8, 2021 respectively. more…
In recent years, with the continuous application of new technology in China’s medical device industry, new products of rehabilitation equipment emerge in endlessly, including rehabilitation robots, rehabilitation aids, physiotherapy equipment and rehabilitation function evaluation system. more…
On September 2, 2021, Guideline for Registration Review of Neurosurgical and Cardiovascular Surgical Devices – Knife, Scissors and Needles (Draft) drafted by CMDE of NMPA was released to solicit comments, which aims to help and guide the registration applicants to prepare the application dossiers to meet the standards of technical review. Any feedback needs to be submitted by October 18, 2021. more…
To further optimize the business environment in Hainan Boao Lecheng pilot zone of international medical tourism (the Pilot Zone), simplify the approval process of imported drugs and medical devices in urgent clinical need, optimize the approval mode, improve the effectiveness of regulatory services, facilitate the public to timely use imported drugs and medical devices in urgent clinical need, the Several Measures to Further Optimization of Regulatory Services to Support the High-Quality Development of Hainan Boao Lecheng Pilot Zone of International Medical Tourism (the Measures) was issued by Hainan Provincial Drug Administration and related bodies. more…
