Understanding China\’s Medical Device Classifications for Marketing Authorization

To acquire China National Medical Products Administration (NMPA)’s marketing authorization for medical devices, companies need to file or register the devices under certain classifications. In China, medical device classifications are determined based on multiple factors, including the duration of use, the place where the device contacts the human body, the degree of influence on medical effect, the degree of injury caused by losing control of the device, and the degree of influence on medical effect. Terms To determine the classification of medical devices correctly, applicants need to know the relevant definitions: 1. Intended Purpose Intended purpose is the effect that the medical device should achieve as indicated in the package insert, label, or brochure. 2. Non-active Medical Device Non-active medical device refers to any medical device whose purpose is achieved by energy generated by human body or gravity, instead of electric power or any other power. 3. Active Medical Device…

Jun. 29th, 2023

China Requires Electronic Submission of Drug Registration Docs from Jan 2023

On Jan. 1, 2023, China National Medical Products Administration (NMPA) started to require that all documents for drug registration applications, as well as supplemental documents sent during the review, shall be submitted electronically in compact disks with no paper.1 Before this, only some documents, e.g., the application form, were required to be submitted in compact disks while other documents were required in paper. Now all documents should be stored in compact disks. The application documents should be organized in the following structure2: Application Type Folder Documents Clinical trial application and marketing authorization application for chemical drug and biological product Application info Application form, self-review form, commitment letter, etc. Module 1 (M1) Administrative documents and drug info M1: Administrative documents and drug info M2 CTD summary M2: CTD summary M3 Quality M3: Quality M4 Non-clinical research report M4: Non-clinical research report M5 Clinical research report M5: Clinical research report Clinical trial…

May. 29th, 2023

China CDE Q&A: Electronic Drug Application and DMF Filing

On Mar. 3, 2023, China Center for Drug Evaluation (CDE) released six Q&As on drug master file (DMF) filing (Q&A No. 1-2) and drug application’s electronic submission (Q&A No. 3-6). ChemLinked BaiPharm Team translated the Q&As into English. In case of any discrepancies between the English translation and the original Chinese text, the original shall prevail. Related: – China Requires Electronic Submission of All Drug Registration Application Documents from Jan. 1, 2023 – China CDE Q&A on Drug Application\’s Electronic Submission and More – China DMF Filing for APIs, Pharmaceutical Excipients & Packaging Materials Q1: When an approved API is changed and the change has already been notified, if the change involves the publicized DMF information on CDE’s website, how should the active pharmaceutical ingredient (API) DMF filer change the corresponding publicized information? A1: According to Article 19 of the Administrative Measures for Post-approval Changes of Drugs (Interim), to change an approved API, the API DMF filer shall determine…

May. 29th, 2023

China MEE Publishes New Chemical Record Registration Statistics in 2022 H2

By a notice issued on April 7, 2023, the Chinese Ministry of Ecology and Environment (MEE) made public 3,069 new chemical record registrations that were received in the second half of 2022, covering more than 21,600 new chemical substances. The attached list contains the applicant and the corresponding representative agent (if any), the time for record registration, the receipt number, and the number of new chemical substances. Details can be accessed here.Under MEE Order No. 12, new chemicals manufactured or imported in quantities below 1 ton per year, polymers containing less than 2% of a new chemical monomer/recant, or PLCs are subject to record registration. Notably, there’s no approval for record registration, which means that businesses can start relevant activities immediately after submitting application materials and receiving the receipt sent via the online registration system. However, in practice, it doesn’t mean that obligations under record registration are that easy to fulfill….

Apr. 14th, 2023

China\’s MOARA Launches New Pesticide Coordination Mechanism to Enhance Efficiency and Safety

On January 19, 2023, the General Office of China’s Ministry of Agriculture and Rural Affairs (MOARA) issued a notice on the establishment of a coordination mechanism for pesticide registration information, aimed at streamlining administration and delegating power, improving government, and upgrading services. The notice requires all registration applicants to designate a coordinator who is familiar with pesticide registration to handle their applications on their behalf. The coordinator can be an employee of the applicant or an employee of the entrusted agency. Ministry of Agriculture and Rural Affairs of the People’s Republic of China Announcement The new coordination mechanism is intended to optimize the management service of pesticide registration, clarify the main responsibilities of the applicant, standardize the intermediary agent, and improve the accuracy, scientificity, and fairness of pesticide registration management service. By linking up the submission of application materials with the feedback of examination and approval information, the Ministry of…

Mar. 31st, 2023

Discover 2023\’s Evolving Regulatory Landscape in REACH24H’s 2022 Annual Report

HANGZHOU, 24 February 2023 – REACH24H is proud to announce the release of its 2022 Annual Report, showcasing a year of achievements and milestones. The REACH24H 2022 Annual Report provides a comprehensive review of REACH24H’s performance over the past year and offers a glimpse into the future trends and compliance points in global markets. A Glimpse of 2023 Regulatory Landscape Industrial Chemicals: EU SDS Required to Meet the Requirements of Regulation (EU) 2020/878 From 2023; China Released GB 15603-2022 General Rules for the Hazardous Chemicals Warehouse Storage; … Agrochemicals: Glyphosate’s Expiry Date Extended in the EU; U.S. Pesticide Registration Improvement Act of 2022 (PRIA 5); … Cosmetics: Additional Human Efficacy Test Reports Required Before May 2023 for Certain Cosmetic; U.S. Modernization of Cosmetics Regulation Act of 2022; … Food: China to Implement GB10765-2021 for Infant Formula; … Food Contact Materials: EU Mandates Use of “Suitable” Recycling Technologies for Food Contact…

Feb. 24th, 2023

China Marketing Authorization Holder (MAH): Responsibilities for Drug Quality

After consulting on the draft in Nov. 2022, China National Medical Products Administration (NMPA) released the Administrative Rules on Supervising Drug Marketing Authorization Holder as the Main Entity to Fulfill Responsibilities Drug Quality (hereafter referred to as the Rules) on Dec. 29, 2022. The Rules will take effect on March 1, 2023. The Rules apply to MAHs in China, requiring them to obey the Drug Administration Law and relevant laws & regulations; comply with Good Manufacturing Practices (GMP), Good Supply Practices (GSP), Good Pharmacovigilance Practices (GVP); establish and improve the drug quality management system; be responsible for the safety, effectiveness, and quality controllability during drug development, manufacture, supply, and use. The Rules detail the drug quality responsibilities in the following aspects: Main Aspects of Drug Quality Responsibilities in China MAH Organization and Departments Key persons: – Legal representative, responsible person of the corporate – Responsible person for manufacture – Responsible person for quality – Qualified Person (QP) – Responsible person for pharmacovigilance…

Feb. 20th, 2023

China\’s Good Pharmacovigilance Practices (GVP): Decoding PV Compliance in China

On May 13, 2021, China National Medical Products Administration (NMPA) released the Good Pharmacovigilance Practices (GVP), which has been effective since Dec. 1, 2021. GVP requires drug marketing authorization holders (MAHs) and drug registration applicants to establish and improve pharmacovigilance (PV) systems as well as conduct pharmacovigilance activities compliantly. Pharmacovigilance activities are subject to national and provincial medical products\’ inspections according to the Pharmacovigilance Inspection Guidelines. To help pharmaceutical companies with PV compliance in China, this article introduces: 1. GVP Application Scope 2. China GVP Contents 3. Pharmacovigilance for MAHs 3.1 Pharmacovigilance System Quality Management 3.2 Pharmacovigilance System Master File 3.3 Individual Case Safety Report 3.4 Post-market Safety Study 3.5 Periodic Safety Update Report 3.6 Risk Management 4. Pharmacovigilance for Drug Applicants 1. GVP Application Scope The Chinese GVP applies to pharmacovigilance activities of   Drug marketing authorization holders (MAHs); and drug registration applicants approved to carry out clinical trials. Pharmacovigilance activities refer to activities to…

Feb. 01st, 2023

China CDE Answers Questions on Drug Application\’s Electronic Submission and More

On Jan. 11, 2023, China Center for Drug Evaluation (CDE) released 10 Q&As, including nine questions on the electronic submission of drug applications and one on the application of overseas drugs for China’s marketing authorization. Related: China Requires Electronic Submission of All Drug Registration Application Documents from Jan. 1, 2023 ChemLinked BaiPharm Portal translated the Q&As for your reference. In case of any discrepancies between the English translation and the original Chinese text, the original shall prevail. Q1: Does the applicant have to submit application documents in paper if the application was accepted by CDE after format review, and the application was received by CDE before China National Medical Products Administration (NMPA)’s Announcement on Implementing Electronic Submission of Drug Registration Applications took effect on Jan. 1, 2023? For example, the application was signed for by CDE on Dec. 30, 2022, and was accepted on Jan. 6, 2023. A1: The applicant is required to submit…

Jan. 18th, 2023

China Clinical Trial Application / Investigational New Drug Application Procedures

In July 2018, China optimized the clinical trial applications (CTA) / investigational new drug (IND) applications\’ review and approval procedures. Instead of waiting for the formal approval notification after lengthy procedures, the applicant can start the clinical trial if there are no rejection notices or questions from the Center for Drug Evaluation (CDE) within the first 60 workdays from the day when the application is accepted by CDE. This is why it\’s called implied approval. To help international pharma companies register drugs in China, this article introduces IND Applicant Qualification IND Application Scope IND Application Dossier IND Application Submission Procedures BaiPharm\’s IND Application Service 1. IND Applicant Qualification Domestic applicants should be companies or drug research institutions that are registered in China and capable of taking legal responsibilities independently. Overseas applicants should be lawful pharmaceutical companies. They should appoint corporate entities in China to act as their local agents for submitting the application….

Jan. 13th, 2023
  • 문의하기
  • +82-02-6245-1610
  • korea@reach24h.com

TSCA Inventory Search Tool