CHINA FDA MEDICAL DEVICES TECHNOLOGY CHINESE MARKET FDA

Medical Device and IVD Registration in China

Author:CRS Addtime:2015-01-13 Hit:1282

In China, Medical Devices (MDD) and In Vitro Diagnostic (IVD) reagents are regulated by following laws:

  • The Regulations for the Supervision and Administration of Medical Devices (Decree No.650 2014)-main regulation
  • Administrative Measures for Medical Device Registration(CFDA Order No. 4 2014)
  • Administrative Measures for the Registration of In Vitro Diagnostic Reagents(CFDA Order No. 5 2014)
  • The Provisions on Class I Medical Device Notification (CFDA Notice No.26 2014)
  • The Provisions of Medical Device Classification (classification catalogue of medical devices)
  • Administrative Rules for the Instructions and Labels of Medical Devices(CFDA Order No. 6 2014)
  • The Guidelines for the Instructions of In Vitro Diagnostic Reagent Preparation (CFDA Notice No. 44 2014)
  • Administrative Measures for the Supervision of Medical Device Manufacturing(CFDA Order No. 7 2014)
  • Administrative Measures for the Supervision of distribution of Medical Devices(CFDA Order No. 8 2014)
  • GMP-the Quality Management Practices for Medical Device Manufacturing (CFDA order No. 64 2014)
  • GSP- the Quality Management Practices for Medical Device Distributing(CFDA order No. 58 2014)
  • GCP- the Quality Management Practices for Medical Device Clinical Trial (SFDA notice No. 68 2012

Any Medical Device or In Vitro Diagnostic reagents manufacturer seeking to market their product in China must apply for and acquire the Medical Device Registration Certificate from China Food and Drug Administration (CFDA). Foreign companies should appoint local legal agent and service agent to deal with registration and after-sales service if they are not subsidiary or representation office in China.

How to determine the classification

Medical Devices (including IVD) are divided into three managing categories: class I, class II and class III medical devices based on the different risk level. There are higher controlled requirements if the product classified as higher level, such as class II or class III, and there are different requirements for each level as well. So the confirmation of the classification is the most important process and the first step to start the medical device registration. 

The classification should be determined by the combined judgment from four aspects: intended use, structural characteristics, form of operation and intended for use. 

How to market your medical devices in China

The first important aspect of marketing your medical devices in China is to know how to process, CIRS medical device regulatory team will perform as your local regulatory staffs to assist with you to market your product in China step by step.

medical device progress

Registration scope and type for overseas medical devices

Any healthcare product meets the definition of medical device or IVD under CFDA regulations and is being to enter the Chinese market are required to register in China.

Definition of medical device

"Medical devices" are defined as any instrument, apparatus, appliance, material, in vitro diagnostic reagents and calibration substances and other similar substances and related articles, including the needed computer software. Its main effectiveness is achieved via physics ways and so on. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:

  1. Diagnosis, prevention, monitoring, treatment or alleviation of disease;
  2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;
  3. Investigation, replacement or modification for anatomy or a physiological process;
  4. Life support or maintenance;
  5. Control of conception;
  6. Offer information for medical or diagnosis purpose via inspecting the human samples.

Registration type

Medical Devices

Approval

Testing

Clinical Trial

Authorities

Deadline

Class I

Record

Self-testing

N/A

CFDA

Pre-market

Class II

Initial Registration

Required

Required

CFDA

Pre-market

Updates

TBA

TBA

CFDA

Within 1months after being updated

Renewal

TBA

N/A

CFDA

6 months before the date of  certificate expired

Class III

Initial Registration

Required

Required

CFDA

Pre-market

Updates

TBA

TBA

CFDA

Within 1months after being updated

Renewal

TBA

N/A

CFDA

6 months before the date of  certificate expired

How to process the medical device registration in China

medical device registration

Data Requirements for Medical Device Registration

  1. Application form
  2. Documents for evidence
  3. The document to prove the safety and effectiveness of medical device
  4. Summary related to the registered product
  5. Study report (product designed, developed and verified report)
  6. Manufacturing process explanation
  7. Clinical evaluation documents
  8. Product risk assessment report
  9. Document of product technical requirements (former product standards)
  10. Product test report for registration
  11. Draft instructions and labels
  12. Self assurance statement

How to prepare product technical requirements (former product standards)

The product technical requirement for medical device shall be compiled according to the China related national standard of medical product. It is the most important document for product safety and effectiveness evaluating and the appendix of the medical device registration certificate.

How to confirm the clinical trial requirement in China

Companies can check the clinical trial requirement step by step as follows:

medical device confirm

GMP and GSP implementation timelines

Type

Implementation date

GSP

All medical device distributing

Dec, 12th 2014

GMP

Sterile and implantable medical devices manufacturing

Jan, 1st  2011

New establishment or update of manufacturing license for class III medical devices

Oct. 1st 2014

Class III medical devices manufacturing

Jan, 1st 2016

All medical devices manufacturing

Jan, 1st 2018

Risk Assessment & Management

In medical device industry, the risk management is a vital part of all your company’s processes, it involves in the entire lifecycle of a
device. There are different risks raised from each process of a device marketed in China: market risk, regulatory risk and product quality risk. To ensure your company gets a safe and effective product to entry into Chinese market on time and reduce the regulatory risk, a successes implementation of risk assessment and management would be a best support for your business in China.

(by CRS)