Learning from US and Chinese authority

This article is dedicated for all manufacturers especially outside of China and US. US is pioneer of risk based regulation of medical device (IVD). From all sites it acts as example for all other agencies and notified bodies.

China as halyard of medical device has pragmatic regulations aligning more to FDA than international.

Both markets are one of the complex registrations for each regulatory group. Actually there is much transparent information from both markets.

We hope that more law makers and stakeholders in medtech take the regulatory thought behind product registration and quality management requirement into account.

Regulatory framework (product specific guidance)

In both Chinese and US market there is established system of regulation publication. Beginning with draft of regulation, all stakeholders could provide opinion followed by final regulation. Either from Drugs and Cosmetics Act Title, 21-Code of Federal Regulations in US or from State Order No. 739 in China there is compact law language in general. To implement the highest regulation in each market there are supporting guidances for submission dossier, software file, shelf life validation and product specific guidance.

The product specific guidance is unique to follow because for each product type there is typical elements for technical documentation as below to follow:

Performance parameters, risk management, clinical study, labelling, verification and validation testing (non-clinical), modification (design change) and predicate comparison (US 510k).

Product code and classification

In both markets there is a system of product code to classify medical device. Using intended use and indication for use, manufacturers can match product to corresponding product code, in US 5 digits and in China 6 digits.

With same product code in FDA, the predicate device can be easily found. This is others than classification rule as at MDR in EU which leaves many gaps for standalone software and innovative products.

Knowing product code the submission type 510k or PMA can be determined.

In both markets, with product code manufacturers can search general -, specific guidance and applicable standard.

Innovative product

The Chinese market is still not ideally for innovative product with potential Chinese patent and clinical trial needed. Les us focus on policy of innovative product in US.

There are mainly 2 submission types: De Novo and Breakthrough if no predicate device is existing.

Normally for De Novo products it provides a regulatory classification avoiding the more stringent premarket approval (PMA) route.

For Breakthrough Devices Program it is unique to expedite the development, assessment, and review of medical devices that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Manufacturer could have frequent interactions with the FDA during the device development phase.

A good example is for Artificial Intelligence and Machine Learning (AI/ML) product. FDA is pioneer to lead development state of the art for manufacturer and allows real world evidence.

Central database (and other learning material)

Both at authority website in Chinese NMPA and American FDA there is a central database to look after approved medical device by giving product name or legal manufacturer. In US the product code and 510k or PMA number can be used to search too.

Please discover more databases and learning video at FDA.

in China there are many uptodate learning material, as NMPA registration –, review workflow, CMDE Learnning video.

Quality management requirement

For manufacturer there is NO certification process for quality management in Chinese and American markets. After approval depending on post market activities there is a random inspection for risk based products by authorities.

For product registration in China, manufacturers have to submit valid ISO 13485 certificate and provide general production info and SOP in chapter 6 for QMS.

For manufacturer orientated to US market, the harmonisation of QMSR in US with ISO 13485 is also a good news that one QMS is sufficient for US market in the future.

Technical documentation

In both markets there are clear table of content or submission session for manufacturer to submit technical documents. There are not only general guidances for how to assemble technical documents with requirements but also product specific guidance which uniquely guides manufacture proving safety and effectiveness of medical device beyond for submission in the whole life cycle of products.

For reviewer and manufacturer there is even an acceptance checklist of submission dossier which in US could be submitted too.

Risk based - and no clinical evaluation

The clinical evaluation in China is mainly based on comparison to similar product. There is a clear guidance of clinical evaluation with given template. The demand of Chinese CER is still quite high due to special Chinese requirement and Chinese literature. However there is for most product types only a very simple CER-like comparison. There is no clinical evaluation in US.

Even for clinical study, there is a decreasing trend that medical device needs clinical trial in China. Similar in both markets for defined product type as implantable defibrillators, artificial heart valves instead a general highest classification, a clinical trial is needed.

Review of technical documentation

The review systems for technical documentation in China (NMPA) and the US (FDA) are well-defined and transparent, providing clear timelines and requirements.

In China, the NMPA specifies a structured review process for technical documentation, often requiring type testing and alignment with Chinese standards. The timelines for review are predefined, with detailed feedback mechanisms for revisions. This ensures manufacturers know exactly what to expect and can prepare accordingly.

In the US, the FDA follows a predictable review framework for submissions like 510(k), De Novo, or PMA. Each pathway has explicit requirements, such as performance testing and clinical data, with statutory review periods—e.g., 90 days for 510(k) clearance. The FDA also emphasizes interactive reviews, ensuring clear communication and minimizing delays.

Both systems contrast with less structured and variable review approaches elsewhere, offering manufacturers a higher degree of predictability and clarity during the registration process.

Communication with authority

The communication with Chinese authority is easier if a Chinese spoken partner is there especially during the deficiency reply.

There are high professional pre-submission programs at FDA highlighted for pre-market consulting meeting. See our categorised analysis:

Pre-Market Pre-Subs

Regulatory Pathway Determination
Clinical Study Design Feedback
Risk and Benefit Clarification
Predicate Device Comparison (510(k))
Novel or Innovative Technology Review
Combination Product Jurisdiction Clarification

During Review Pre-Subs

Addressing FDA's Additional Information Requests (RAIs)
Labeling or Marketing Claim Adjustments
Design Modifications During Submission
Clarifications on Testing or Data Requirements

Post-Approval Pre-Subs

Post-Market Design Changes
Updates to Labeling or Indications for Use
Post-Market Surveillance Study Plans
Lifecycle Management (e.g., expanded indications or new versions)
Modifications to Manufacturing or Quality Controls

Post market surveillance

The FDA's post-market surveillance system for medical devices stands out due to its proactive and data-driven approach. Unlike the EU MDR, which emphasizes periodic safety updates and mandatory post-market clinical follow-ups, the FDA leverages real-world data through its Medical Device Reporting (MDR) system, the Sentinel Initiative, and the National Evaluation System for health Technology (NEST). This allows the FDA to identify and address safety issues more dynamically. Additionally, the FDA's focus on adverse event reporting and unique device identification (UDI) enables better traceability and faster response to potential risks compared to many other global regulatory frameworks.

In China there is new vigilance system which leads too many register by users. Otherwise there is uncomplicated and easy periodic risk assessment report and quality annual report with fewer efforts by manufacturer.