Presentation on China medical device regulatory updates in 2018, prepared by CIRS China.

1. 2018 Annual Report
China Medical Device
Regulatory
王烁｜ Shuo Wang
Email: md@cirs-group.com

2. Content
China medical device
statistic data in 201801
Summary of NMPA regulation
update in 2018
.
02
Analysis of NMPA regulation
update in 2018
03
Prospect of China medical device
supervision trends in 2019
04

3. China medical device statistics in 2018
1

4. 1.1 China medical device registration
statistics

5. 2017
0 10 20 30 40 50 60
1.2 Innovative Medical Devices approval from
2014-2018
2016
2015
2018
2014
50
64
46
29
17
Summary of innovative medical device from 2014-2018

6. 1.3 Innovative Medical Devices in 2018
185
21
Approved innovative medical device
Domestic Imported
• In total 206 products approved in
2018, 21 are from overseas
companies, and the other 185 are
domestically produced.

7. 1.4 medical device adverse event, irregularity,
recall condition in 2018
2%
26%
72%
Recalled medical device class
distribution
Class I
Class II
Class III
• A total of 110 medical devices
varieties and 3,592 batches of
medical devices have been
inspected, and 301 batches
have failed. The failure rate is
8.38%.
• Up to now, 573 batches of
medical device products have
been recalled in 2018

8. 1.5 China medical device flight inspection
Inspection purpose: Supervising medical device manufactures to
meet the standards of China Medical Device Good Manufacturing
Practice (GMP)
Main problems:
1. Lack of tests
2. The test method is inconsistent
with the report
3. Production equipment
configuration is not in place
4. Testing record is not completed

9. 1.6 China medical device flight inspection
Determine inspection
corporates
Make appointment
Arrive and meeting
local manufactures
Begin inspection
Reporting results on
official website

10. 1.7 China medical device clinical trial
institutions
On January 1, 2018, "Administrative Measures for Conditions and Filing
of Medical Device Clinical Trial Organizations“ is issued
• Units declared to be medical device clinical trial institutions shall be
filed in NMPA separately;
• The Class III medical devices to be approved for clinical trials must be
hold in China grade A hospital;
• The qualifications of other Class medical device clinical trial institutions
have been loosed to Grade B and above.
China's clinical trial institutions for medical devices and
drugs are often bundled together

11. At present, there are 182 medical device clinical trial
institutions that have completed the filing, and the
target is the medical institutions above level II
hospital and other medical institutions.
By the end of 2017, the total number of medical institutions nationwide
was 993,264, and the number of medical institutions above the second level
identified by the Health and Family Planning Commission was 8,285, 2311 in
the third level, 3,481 Centers for Disease Control and Prevention, and more
than 550 blood collection agencies.
1.8 Recording of medical device clinical trial
institutions

12. 2 Summary of CFDA regulation update in
2018

13. 2.1 Medical device institution reform process
• 2018 ｜National Medical Products Administration (NMPA)
Under the State Administration for Market Regulation
• 2013 ｜China Food and Drug Administration (CFDA)
Directly under the State Council

14. No. Medical device regulation Release date Effective date
1
Technical guidelines for accepting overseas clinical
trial data of medical devices
2018.01.11 Immediately
2 Medical Device Standards Planning (2018-2020) 2018.01.29 2018
3
Notice on the implementation of the "Measures for the
Supervision and Administration of Medical Device Network
Sales"
2018.02.24 2018.03.01
4
Medical Device Unique Identification System Rules (Draft
for Comment)
2018.02.26 Solicit opinions
5
Announcement on the Issuance of the "Work Procedures
for Self-Cancellation of Imports of Class I Medical Devices"
(No. 206)
2018.02.08 Immediately
6
Notice on Soliciting Opinions on the Fourth Batch of
Medical Devices Exempted from Clinical Trials (Draft for
Comment) and the First Three Batches of Medical Device
Lists for Clinical Trials (Draft for Comment)
2018.06.08 Solicit opinions
7
The Medical Device Supervision and Administration
Regulations Amendment (Draft for Review)
2018.6.25 Solicit opinions
2.2 China Medical Device Regulation Updates
in 2018

15. No. Medical device regulation Release date Effective date
8
Measures for the Supervision and Administration of
Imported Medical Device Agents (Consultation draft)
2018.08.03 Solicit opinions
9
Administrative Measures of Medical Device Adverse Event
Monitoring and Re-evaluation
2018.08.31 2018.09.01
10
Medical Device Catalog Exempted from Clinical Trials
(Revised)
2018.09.30 Immediately
11
In Vitro Diagnostic Reagent Catalog Exempted from
Clinical Trials (Revised)
2018.02.08 Immediately
12
Notice of the handling of the handling of warehouses
across administrative areas by medical device operating
enterprises
2018.10.31 2019.01.01
13 Special Review Procedures of Innovative Medical Devices 2018.11.05 2018.12.01
14
Administrative Regulations of Drug and Medical Device
Overseas Inspection
2018.12.28 Immediately
2.2 China Medical Device Regulation Updates
in 2018

16. 2.3 China Medical Device Regulation Updates
in 2018
In 2018, the NMPA has issued 1,906 medical device
standards, and 1,891 have been implemented, of which
181 medical device standards have been implemented in
2018, and 61 standards have been issued.
A total of 355 registered technical review guidelines were
issued, of which 113 were implemented in 2018.

17. 03 Analysis of CFDA regulation update in
2018

18. www.cirs-group.com
Sub-category
setting
Sub-category distribution
Surgical
instruments
01 Active Surgical instruments
02 Passive Surgical instruments
03 Neurological and cardiovascular surgical instruments
04 Orthopedic surgical instruments
Active devices
05 Radiation therapy device 06 Medical imaging device
07 Medical examination and monitoring equipment
08 Respiratory, anesthetic and emergency equipment
09 Physical therapy device 10 Blood transfusion, dialysis
and extracorporeal circulation devices
11 Sterilization and sterilization equipment 12 Active
implant device
Passive device
13 Passive implantable device
14 Injection, care and protective equipment
15 Patient carrying device
According to the
clinical
department
16 Ophthalmic instruments 17 Dental equipment
18 Obstetrics and gynecology, assisted reproduction and
contraceptives
Other
19 Medical rehabilitation equipment
20 TCM medical device
21 Medical software 22 Clinical test equipment
Item 2002 version New version
Sub-category 43 22
Product
category
First
category
260
206
Second
category 1157
Product name
example
1008 6609
3.1 New catalogue of medical device classification

19. 3.2 China Medical Device Regulation Updates
in 2018
Prior approval Post-market supervision Full life cycle regulation
Enterprise self-discipline
'Medical Device
Supervision and
Administration
Regulation‘ (State
Council Order No.
650) released
‘Revised Medical Device
Supervision and Administration
Regulations’
(State Council Order No. 680)
The Medical Device Supervision
and Administration Regulations
Amendment (Draft for Review)
was published by the Ministry
of Justice and sought public
opinions.
2014 2017 2018

20. www.cirs-group.com
3.3 Summary of ‘The Medical Device Supervision and
Administration Regulations Amendment Draft’
1. Clarify the system of medical device listing permit holders (national extension of the
registrant system)
2. Reform the clinical trial management system (Class II medical device is basically free of
clinical)
3. Reduce the threshold for clinical trial approval (expressed permission to change to
implied license)
4. Unified review and approval criteria (Class II devices are returned to the NMPA)
5. Reduce the threshold for overseas products (accept overseas clinical, cancel the overseas
market certificate requirement)

21. www.cirs-group.com
3.3 Summary of ‘The Medical Device Supervision and
Administration Regulations Amendment Draft’
6. Broaden the registration inspection channel (accept enterprise self-inspection and third-
party inspection)
7. Establish a professional inspector system (increase the intensity of on-site inspections)
8. Increase the scope of counterfeit medical devices
9. Clarify the division of regulatory authority
10. Significantly increase penalties (increased fines, lifetime bans, criminal liability)

22. www.cirs-group.com
3.4 Summary of ‘The Medical Device Supervision
and Administration Regulations Amendment Draft’
 Reform clinical trial management system
 The registration of the Class II medical device products does not
require clinical evaluation in principle; the Class III medical device
product registration should have clinical evaluation , among which
Class III medical devices with high risk for supporting or sustaining
life or clinical use, In principle, clinical trials are required (Articles 9
and 19).
 Provisions for increasing the acceptance and extended clinical use
of data from overseas clinical trials (Articles 19 and 22).

23. www.cirs-group.com
3.4 Summary of ‘The Medical Device Supervision
and Administration Regulations Amendment Draft’
 Reform and optimization of registration approval
 The registration of the Class II medical device products shall be
reviewed and approved by the drug regulatory authorities of the province
will be directly reviewed under the NMPA, and NMPA may authorize the
review and evaluation, qualified review agencies to carry out review and
approval (Article 8).
 For innovative medical devices that are not listed at market, it is no
longer required to provide overseas marketing certificates (Article 11).
 The product inspection report submitted at registration of the Class II
and Class III medical devices may be a self-inspection report or an
inspection report issued by a qualified medical device inspection agency
(Article 9).

24. www.cirs-group.com
3.5 Medical device Marketing Authorization
Holders(MAH) system
• In the process of applying for the registration certificate of medical devices, the
applicant shall be the marketing authorization holder.
• Establish a quality management system that is compatible with the product and
maintain effective operation;
• Develop a continuous research and risk management plan after listing and ensure
its effective implementation;
• Conducting adverse event monitoring and reevaluation work according to law;
• Establish and implement product traceability and recall systems;
• Other obligations stipulated by the drug regulatory department of the State
Council。
• Enterprises, institutions and individuals entrusted by the holders of medical
device marketing licenses to conduct research and development, clinical trials,
production and operation, bear the responsibility stipulated by laws and
regulations and agreements
What are the obligations?
What is medical device marketing authorization
holders system ?

25. www.cirs-group.com
Commissioned
production
Innovative medical
device approval system
Listing license holder system
Applicant Corporate Corporate
Corporate, research institution or
individual
Sample
production
- No commission of
production samples
-Samples can be
commissioned through
innovatively approved
samples
-The trustee must be a
medical device
manufacturer
- Allow commissioned production
Product
launch
-The entrusting party
and the trustee must
have a medical device
registration certificate
and a production
license.
- Do not allow multiple
orders
-The trustee must be a
medical device
manufacturer
-- Do not allow multiple
orders
-The entrusting party applies for a
medical device registration certificate
or filing voucher; the trustee applies for
a medical device production license
- It allows multi-point commission
- Prohibition commissioned category
does not allow commission
- The trustee must meet the GMP
requirements
3.5 Medical device Marketing Authorization
Holders(MAH) system

26. Registratio
n
certificate
Production
License
Market
approval
1. Research and development samples shall not be commissioned for
production
2. Innovative products allow commissioning of production samples, but
the entrusting party must have a corresponding registration certificate
and production license.
3. R&D samples should be produced in their own factories to meet GMP
requirements.
4. Quality management system assessment has high requirements for
the authenticity of the research and development samples and the
hardware requirements of the factory.
5. Long registration process and high cost
Constraint
3.5 Medical device registration permit holders
system

27. 04 Prospect of China medical device
supervision trends in 2019

28. 4.1 Medical device regulatory trends in 2019
Marketing
licensing holder
system is fully
implemented
• New medical device
category（effective from
2018.08.01）
• Dynamic management
(Classification adjusting)
• New product classification
procedure
• Medical device unique
identifier（China UDI）
Classification
management
system
adjustment
• Regulatory revisions are
frequent and complex
• Regulatory body and
means adjustment
• Accelerate the launch of
new products or
innovative medical device
products
• Pay more attention to
process or quality
supervision after
marketing
Clinical trial
requirement
adjustment
• Clinical trial institute filing
• Simplified clinical evaluation
• Increase clinical exempted
list
• Accept oversea clinical trial
data
• Drafting the "Regulations on
the Development of Medical
Device Explosive Clinical
Trials”
• Establish a team of clinical
trial inspectors and increase
clinical supervision and spot
checks
Post-marketing
supervision
strengthened
• Increase flight check
frequency
• Increase penalties，
higher requirements
for employee
• Unified review criteria
and measurement
• Change testing institute
recognition mechanism
• Industry impact
brought about by the
rapid influx of new
products in the
industry

29. Detailed regulatory rules will
gradually be introduced.
The Directorate is evaluating
the pilot effect
4.1 Medical device regulatory trends in 2019

30. www.cirs-group.com
4.2 Suggestion for medical device enterprises under
the new policies
• Prepare and consider
the application
strategy, method,
project budget in
advance
• Strength the training
of professional team,
the RA team shall
join the project as
earlier as possible
• Regulate the design and
development procedure,
perfect the basic
research and verify and
keep the relevant
document
• Risk management shall
combine with product life
circle, parallel with
quality management
system to ensure
marketing compliance
Risk
Management
R&D
Registration
strategy
Professional
team

31. Kind reminder
On November 2017, CFDA have issued a new notification:
‘Announcement of the General Administration on the use of
Chinese name of the applicant for registration and filer of
imported medical devices’ :
All imported medical device companies shall add their Chinese
company name on the at least one certificate in the CFDA
system.
Deadline: 31st December, 2018.

32. Kind reminder
The report covers the most comprehensive regulatory changes in China's
medical devices in 2018.
Content:
I. Registration and Approval Condition in 2018
II. Summary of Chinese Medical Device Regulations
III. Analysis of the implementation of the
regulations
IV. Main Medical Device Industry Development
Report
V. Definition and Explanation

33. www.cirs-group.com
CIRS Ireland
CIRS Group(China)
CIRS NanjingCIRS Beijing
关于CIRS
 CIRS is a leading global product safety management consulting company with its headquarters based in Hangzhou
of China, and branches in Dublin (Ireland), Korea, USA, Beijing, Nanjing and Ninbo. CIRS was founded in 2007 and
currently has 200+ employees with an annual turnover of approximately 25,000,000 USD。
 CIRS provides product regulatory compliance consulting, testing and training services
 CIRS provides China medical device registration, clinical trial, system and compliance service
 Over 4,000 customers worldwide
CIRS US CIRS
Testing

34. www.cirs-group.com
Medical device clinical trial
service
-Medical device and in vitro
diagnostic reagent clinical trial
-Preclinical research on medical
devices
-Medical device clinical trial
design
-Clinical trial third party audit
-Data management and
statistical analysis
-Clinical trial report and clinical
evaluation data writing
-Medical device clinical audit
-Clinical Field Coordinator CRC
Appointment
Medical device compliance service
-Pre-registration compliance
analysis and registration
consultation
-Product classification, attribute
definition and registration plan
development
-Medical device and in vitro
diagnostic reagent registration
(reservation)
-Registration change or renewal
registration application
-Registration detection and
commissioned inspection
commission tracking
-Registration technical
documentation and submission
-Class I medical device filing
Medical device quality system
management system
-Project analysis and planning
before system introduction
-System design and consulting
-System establishment and
operation counseling
-System training and review
-System on-site audit and
rectification counseling
-Registration system
verification
-Simulated flight inspection
and system rectification
-Risk management input
What can we offer ?

35. Thank You!
Headquarter: 11/F., Bldg 1, Dongguan Hi-Tech Park, 288 Qiuyi Rd,
Binjiang District, Hangzhou, China
Beijing office: Room 1109-1111, 7th Floor, Dacheng Square, No. 28
West Xuanwumen Street, Xicheng District, Beijing
Web：www.cirs-md.com Phone：+86 -571-8720 6541
E-mail：md@cirs-group.com
Wechart: CIRS-MD