Core Principles:
Official Priority: The official websites of the regulatory authorities for drugs and medical devices in various countries/regions (NMPA, EC/EU, FDA) are the most authoritative sources for obtaining original regulations, guidelines, databases, and the latest updates.
Standards Organizations: International standards organizations (ISO, IEC) and national standard organizations (such as SAC in China, ANSI in the USA) are the official channels for finding coordinated standards.
Industry Databases/Platforms: Some databases provided by commercial or industry organizations (such as FDA Recognized Standards, EUDAMED) can offer more convenient search and integration of information.
1. China (NMPA – National Medical Products Administration)
NMPA Official Website:
URL: https://www.nmpa.gov.cn/
Purpose:
● Find original regulations (such as the “Regulations on the Supervision and Administration of Medical Devices”, “Management Measures for the Registration and Filing of In Vitro Diagnostic Reagents”, “Management Measures for the Registration and Filing of Medical Devices”, etc.).● Obtain official announcements, notices, policy interpretations, and drafts for public comment.● Query the catalog of medical device classifications and IVD classifications (critical!).● Link to the Medical Device Standards Management Center.● Query product registration certificates/filing information, clinical trial approval information, GMP inspection information, etc.● Key areas for regulatory/standards search: The “Medical Devices” section -> “Regulatory Documents”, “Standards Management”, “Classification Definition”, “Product Query”, etc.
National Medical Products Administration Medical Device Standards Management Center:
URL: https://www.nifdc.org.cn/nifdc/bshff/ylqxbzgl/
(Usually linked from the NMPA official website)
Purpose:
● Find the official catalog and full text of mandatory standards (GB, GB/T, YY, YY/T) and recommended standards for medical devices in China (some are free, some need to be purchased).● Understand the dynamics of standard formulation and revision, drafts for public comment.● Query information on medical device classification definitions.● Key areas for standard search: “Standard Query”, “Standard Disclosure”, etc.
National Standard Information Public Service Platform:
URL: https://std.samr.gov.cn/
Purpose: Query the catalog, status, plans, etc. of all national standards (GB series). This is the official unified entry for querying GB standards (including medical device-related GB). Some standards can be read online.
2. European Union
EUR-Lex – EU Law Database:
URL: https://eur-lex.europa.eu/homepage.html
Purpose: Find the official texts, amendment history, and current valid versions of EU regulations (Regulations) and directives (Directives)..
Core Regulations:
Medical Device Regulation (MDR – EU 2017/745): Replaces the original Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical Device Directive (AIMDD 90/385/EEC).
In Vitro Diagnostic Medical Device Regulation (IVDR – EU 2017/746): Replaces the original In Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC).
Search Method: Enter the regulation number or keywords to search.
European Commission – Directorate-General for Health and Food Safety (DG SANTE) – Medical Devices Page:
URL: https://health.ec.europa.eu/medical-devices-sector_en
Purpose:
● Obtain the latest progress on the implementation of regulations, guidance documents, frequently asked questions (FAQ), and lists of harmonized standards.● Link to the EUDAMED database.● Understand information about Notified Bodies (NB).● Key areas for standard search: Find the official published lists of MDR harmonized standards and IVDR harmonized standards (this is key to determining whether standards can be used to demonstrate compliance with regulatory requirements!).
Official Journal of the European Union (OJEU):
URL: (Usually accessed via EUR-Lex)
Purpose: Formally publishes EU laws (including updates to the lists of harmonized standards for MDR/IVDR). When searching for relevant regulations in EUR-Lex, its attachments (including standard lists) will link to the corresponding publications in OJEU.
EUDAMED (European Database on Medical Devices):
URL: https://ec.europa.eu/tools/eudamed/
Purpose: The official EU medical device database (still being gradually implemented). The goal is to become a comprehensive platform containing information on device registration, UDI, certificates, clinical research, vigilance, and market surveillance. It will be the main official source for querying compliant device information in the future.Note: Some modules are online, while others are still in development/mandatory implementation phase.
Notified Bodies (NB) Websites:
Representative Organizations: BSI (https://www.bsigroup.com/), TÜV SÜD (https://www.tuvsud.com/), TÜV Rheinland (https://www.tuv.com/), DEKRA (https://www.dekra.com/) etc.
Purpose: Although unofficial, the main NB websites usually provide detailed MDR/IVDR guidelines, white papers, FAQs, and training information, which are very helpful for understanding regulatory requirements and implementation.
3. United States (FDA – Food and Drug Administration)
FDA Center for Devices and Radiological Health (CDRH) Official Website:
URL: https://www.fda.gov/medical-devices
Purpose:
● The most core official resource!● Find the relevant chapters related to medical devices in Title 21 of the Code of Federal Regulations (CFR) (especially Part 800-898).● Obtain guidance documents, policy memos, industry guidance.● Product Classification Database: Query device classification, regulatory requirements (510(k), PMA, De Novo, etc.), applicable standards by product code (P-Code) or keyword.● Recognized Consensus Standards Database: Extremely important! Query FDA-recognized consensus standards that can be used to support premarket submissions (such as 510(k)) (such as ISO, IEC, ANSI/AAMI, ASTM, etc.).● Regulatory Submission Database (510(k), PMA, De Novo Database): Query public summary information of marketed devices (not full text).● Unique Device Identifier Database (GUDID): Query information on devices assigned UDI.● Medical Device Reporting Database (MAUDE): Query adverse event reports.● Key areas for regulatory/standards search: The “Laws, Regulations, Standards” section, “Device Advice” resources, “Databases” section.
American National Standards Institute (ANSI) Online Store / IHS Markit Standards Store:
URL (ANSI): https://webstore.ansi.org/
(ANSI is the national standards coordinating body in the USA, selling the standards it adopts, including AAMI, ISO, IEC, etc.)
URL (IHS): https://global.ihs.com/
(Large commercial standards distributor)
Purpose: Purchase American National Standards (ANSI), especially the medical device-specific standards developed by ANSI/AAMI (such as ANSI/AAMI ISO 13485, ANSI/AAMI ES60601-1, ANSI/AAMI ISO 14971, etc.) as well as the official English versions of other international standards (ISO, IEC).Note: Standard texts usually need to be purchased.
AAMI (Association for the Advancement of Medical Instrumentation) Website:
URL: https://www.aami.org/
Purpose:●Understand the dynamics of the formulation of American medical device standards (especially the ANSI/AAMI series).● Obtain resources, training, publications related to standards.（Although not an official channel for free access to standards, it provides standard information and purchase links.）
4. International Standards Organizations (Applicable for Global Coordination)
International Organization for Standardization (ISO):
URL: https://www.iso.org/
Purpose: Find ISO standards (such as ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management), ISO 10993 (Biocompatibility), ISO 11135/11137/17665 (Sterilization), ISO 23640 (IVD Stability), etc.) official information. Some standard previews are free, full texts need to be purchased.
ISO/TC 210 (Quality Management and General Requirements for Medical Devices): https://www.iso.org/committee/54950.html
Focus on core medical device standards.
International Electrotechnical Commission (IEC):
URL: https://www.iec.ch/
Purpose: Find international standards in the field of electrotechnology, especially safety of medical electrical equipment (IEC 60601 series) and electromagnetic compatibility (IEC 61000 series, CISPR 11) and other key standards. Some standard previews are free, full texts need to be purchased.
IEC/SC 62A (General Requirements for Medical Electrical Equipment): Focus on 60601 series standards.
IEC/SC 62D (Medical Electrical Equipment – In Vitro Diagnostic Equipment): Focus on specific electrical safety standards for IVD devices.
Summary Recommendations
Starting Point:
Start from the official websites of regulatory authorities in various countries (NMPA, EC DG SANTE, FDA CDRH) to understand the regulatory framework, core requirements, and official guidelines.
Classification:
Use official classification databases/catalogs (China’s classification catalog, EU needs to combine MDR/IVDR Annex VIII and EUDAMED/Notified Bodies, FDA product classification database) to determine the regulatory category and pathway of the product.
Standards:
China: Prioritize checking the NMPA Medical Device Standards Management Center and the National Standard Information Public Service Platform.
EU: Check the MDR/IVDR harmonized standards list published on the European Commission’s official website..
USA: Check the FDA CDRH Recognized Consensus Standards Database..
International Standards: Visit the ISO and IEC official websites for queries and purchases.
Database Utilization: Make good use of official product/standard/adverse event databases (such as China’s registration/filing query, EUDAMED (gradually improving), FDA’s 510(k)/PMA databases, GUDID, MAUDE, Recognized Standards).
Timeliness: Medical device regulations and standards are updated frequently, so be sure to pay attention to the latest announcements, revisions, and transition arrangements on official websites.
Commercial Databases: There are also some excellent paid commercial databases on the market (such as Omnexus (SpecialChem), Cortellis Regulatory Intelligence, etc.), which integrate global regulations, standards, and guidelines, and provide advanced search, update reminders, etc., suitable for in-depth use by corporate regulatory departments. However, official free resources are always the foundation.
This list covers mainstream official and core industry resources, which should meet your basic needs for searching IVD/MD regulatory standards in China, Europe, and the USA. Wish you success in your work!
