CFDA, NMPA Guideline for Medical Device Registration in China

12^th Feb, 2014, the revised ‘Regulations for the supervision and administration of medical device’ (2014 version) has passed by the state council of People’s Republic of China. This version does reduce the license requirements and adjusted the approval duration and administrative department. In particular, the class I medical devices are no longer required to register and only required to report for record, class II and class III medical device are required the license as before. The term of validity of registration certificate change to 5 years compare with before is 4 years.

How to market your medical device in china?

For external company who wants to sale their medical devices in China, the priority thing is to follow the local registration procedure to won the license.

Here is the Registration procedure in below:

The definition and classification of the medical devices in China

Definition: Medical Devices are the devices, in vitro diagnostic reagent, calibration object, material and other related matters including the software that directly or indirectly working on the human body. It is effective through the physical way instead of the pharmacology, immunology and metabolism. Or these methods participate in but only a supplementary role.

1. Classification

According to the ‘Regulations for the Supervision and Administration of Medical Devices’, the classification of medical devices are based on the risk level;

Class I medical device

-low risk level;

-the safety and efficiency of medical devices can be ensured through supervision and management.

Class II medical device

-medium risk

-strict controls are required to ensure the safety and effectiveness of the device

Class III medical device

-highest risk

-special controls are required to ensure the safety and effectiveness of the device

Four main methods to determine the classification

1) Search the medical device classification database (CIRS database)

2) Classify your product based on the classification rules

3) Look up the classification catalog for the similar products

4) Apply for classification determination from NMPA

2. China Legal Agent & Service Agent

Any overseas establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into China must identify a China agent for that establishment. Each imported medical device shall designate only one China agent. What’s more is that the foreign company shall also designate at least one qualified institute to be the after-service agent, who is responsible for adverse events monitoring, recalls and after service only.

The responsibilities of the legal agent:

1) Fully responsible for the record or registration of imported medical devices.

2) Assist communication between NMPA and the overseas applicant.

3) Accurately deliver regulations and technical requirements to the overseas applicant.

4) Gather adverse events and reply both to NMPA and the overseas applicant.

5) Coordinate with the recall.

6) Other responsibilities involved with product quality and after-sale service

3. Registration application

The registration application is based on the intended use, classification, product research information and exempted from clinical trial or not.

4. Technical requirements

Compile your producttechnical requirements according to the international standards/national standards/industrial standards. Include your product name, model/specification, performance, standards, testing method, labels, instruction manual, terminology, appendix, etc.

5. Product testing

Materials required for testing is the technical requirements, instruction manual, label, packaging and typical samples. Also you need to conduct the test in the qualified laboratory.

6. Clinical evaluation, trial/exemption

Class II and III Medical devices with much higher risk are required to conduct clinical trial, they are divided into clinical trial and clinical verification depending on whether the risk can be controlled. Only devices those are listed in the ‘Catalogue of Medical Device Exempted from Clinical Trial’ can be free of clinical trial, however the clinical evaluation report is still required.

7. Dossiers preparation

Dossiers preparation shall comply with the NMPA 2014’Requirements and Instructions for Imported Medical Device Registration Application’. Also dossiers shall be submitted to NMPA by the legal agent.

8. Technical review in CAS&CMDE

The Center of Administrative Service (CAS) will be the one who check dossiers and decide whether to accept or refuse the submission. if accepted by CAS, the center of medical Device Evaluation will continually conduct technical review on submitted dossiers and make decisions on supplementary.

9. Certificate issue & post-market

The legal agent shall be in charge of the after-sale service after certificate issuance, which includes adverse events monitoring, recalls and other after-sale service. Post-market products shall comply with technical requirements raised in the registration. The distributing of product shall comply with related NMPA regulations.

Work flow link (https://www.cmde.org.cn/CL0156/)

CIRS Introduction

CIRS is a professional product regulatory compliance and technical consulting service firm. With its headquarters based in Hangzhou of China and offices and laboratories located in Europe, Beijing, Nanjing, Ningbo and Hong Kong.

The CIRS Medical Device Business Unit has a long-term commitment to researching product technology, laws and regulations and industry policy of domestic and oversea medical devices. with its professional and technical experiences, multiple resources and global network, CIRS assist domestic and oversea medical device enterprises with a comprehensive service chain and one-stop solution in medical devices regulation and technical consulting services, including medical devices registration and approval, clinical trials, quality management system, manufacturing and distributing license, technology consulting, laws and regulations training. We are dedicated to medical devices enterprises gaining competitive advantage by reducing business risks associations with regulatory affairs and removing barriers to entry.

Our Medical Devices Registration Services

l Regulatory compliance assessment and registration consulting

l Product classification, attributes defined and registration proposal confirmed

l Registration (recoding) for medical devices and in vitro diagnostic (IVD)

l Registration certificate update and renewal for medical devices and IVD

l Coordinate the registration inspection and commissioned inspection

l Compilation and submission of technical construction file

Medical Device Clinical Evaluation

l Pre-research on medical devices clinical trial

l Clinical Trials Study Design and Protocol Development

l Clinical trial Management and Monitoring

l Clinical trial data management and statistical analysis

l Clinical trial study auditing and quality control

l Clinical trial evaluation and reporting

Medical Device Quality Management System Services

l QMS Design and Consultation

l Risk and Quality Management

l Medical Device QMS Training

l QMS On-site Auditing Assessment

l Overseas Medical Device Production QMS Verification