“Schedules of controlled substances established by section 202 of the Act (21 U.S.C. 812) and nonnarcotic substances, chemical preparations, veterinary anabolic steroid implant products, prescription products, anabolic steroid products, and cannabis plant material and products made therefrom that contain tetrahydrocannabinols excluded pursuant to section 201 of the Act (21 U.S.C. 811), as they are changed, updated, and republished from time to time, are set forth in this part.”
This part was updated on this date to insert under § 1308.11 Schedule I Effective Date Notes the following: “Congress extended the effective period for (h)(30) until Sept. 30, 2025 by Public Law No. 119-4.”
The Ministry of Health, Labour and Welfare has decided to partially amend the "Approval Standards for Intravascular Endoscopes." Therefore, we are seeking opinions on the proposed amendments to these standards from the general public.
Comment period closes on Apr 30, 2025.
This standard is applicable to sterilized vascular endoscopy supplied for providing images for the diagnosis or treatment of blood vessels and the heart, as well as reusable vascular endoscopy supplied in a non-sterilized state.
Under the Act on Securing Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, etc. (Act No. 145 of 1960), the standards for designated highly controlled medical devices and controlled medical devices (hereinafter referred to as "designated highly controlled medical devices, etc.") are established under Article 23-2-23, Paragraph 1 of the Act. These devices are required to comply with the Basic Requirements Standards specified by the Minister of Health, Labour and Welfare under Article 41, Paragraph 3 of the Act (Ministerial Notification No. 122 of 2005). To ensure compliance with these standards, the "Conformity Checklist for Designated Highly Controlled Medical Devices, etc." (Notification No. 0325-1 issued by the Director of the Minister's Secretariat, Ministry of Health, Labour and Welfare, on March 25, 2015) is used as a reference for verification.
Should you need a translation of the tables, please contact csm@redica.com.
As of today, the revision of certain medical devices designated by the Minister of Health, Labour and Welfare, based on the provisions of Article 23-2, Paragraph 1 of the Act on Securing Quality, Efficacy, and Safety of Pharmaceuticals and Medical Devices (Notification No. 125 of 2025), has been applied. Consequently, the annex to the Director Notification has been revised as outlined below.
Regarding the March 29, 2018 Notification No. 0329-1 from the Director of the Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, titled “Regarding the Pharmaceutical Excipients Standards 2018,” and the March 28, 2024 Notification No. 0328-1 from the Director of the Pharmaceutical Bureau, Ministry of Health, Labour and Welfare, titled “Partial Amendment to the Pharmaceutical Excipients Standards 2018,” corrections are now required. As such, we are sending the errata as attached.
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The document outlines the inspection plans and criteria for various categories of medical devices that will be subject to quality supervision and spot checks by regulatory authorities in 2025.
This is an official list detailing the original inspection and re-inspection institutions responsible for quality control of medical devices in China for the year 2025. These inspections are part of regulatory oversight by Chinese health authorities to ensure safety, efficacy, and quality of medical products.
In accordance with the "Drug Administration Law of the People's Republic of China," the "Opinions of the CPC Central Committee and the State Council on Deepening the Reform of the Medical Security System," and the "Implementation Opinions of the General Office of the State Council on Strengthening the Regular Supervision of Medical Security Fund Usage," efforts will be made to leverage the national unified medical insurance information platform and the drug traceability system of drug marketing authorization holders. The goal is to actively promote the traceability of the entire process of drug production, circulation, and usage, as well as the full-process, full-scale collection and full-scenario application of drug traceability codes in medical security and work injury insurance.
Drug marketing authorization holders (including designated domestic persons responsible for overseas drug marketing authorization holders) and manufacturers must assign traceability codes to each sales packaging unit in accordance with relevant regulations and information standards set by the drug regulatory authorities. They must also ensure the association between the traceability codes of different sales packaging units, guaranteeing the accuracy and uniqueness of the codes, and implement traceability coding at the time of the official commercial drug launch. Drug marketing authorization holders and manufacturers are encouraged to upload traceability information for each sales packaging unit to the national unified medical insurance information platform during drug sales, facilitating verification and feedback by medical institutions.