Decree 7 Measures For Supervision And Administration Of Medical Device Production

Measures for the Supervision and Administration of Medical Device Production
Chapter Ⅰ General Provisions
Article 1 To strengthen the supervision and administration of medical device production, sta
ndardize the production of medical device, and ensure the safety and effectiveness of medical devi
ce, these measures are developed according to the Regulations for the Supervision and Administrat
ion of Medical Device.
Article 2 Whoever engages in the production of medical devices within the territory of the
People’s Republic of China and the supervision and administration thereof shall abide by these Me
asures.

Article 3 The CFDA shall be responsible for supervising and administering medical device
production nationwide. The food and drug administration at or above the county level shall be res
ponsible for supervising and administering medical device production within its administrative reg
ion.
The food and drug administration at a higher level shall be responsible for directing and overse
eing the supervision and administration of medical device production conducted by food and drug
administration at lower levels.
Article 4 The CFDA shall prepare quality management rules for medical device production a
nd supervise the implementation thereof.
Article 5 Food and drug administration shall, in a lawful and timely manner, issue the inform
ation on the licensing and recordation of medical device production. The applicants may inquire a
bout the approval process and results; and the public may consult approval results.
Article 6 Medical device production enterprises shall be responsible for the quality of produc
ed medical devices. In the case of the entrusted production of medical devices, the entrusting party
shall be responsible for the quality of medical devices to be produced upon entrustment.
Chapter Ⅱ Production Licensing and Recordation Administration
Article 7 To engage in medical device production, the applicant shall meet the following co
nditions:
(1) It has the production premise, environmental conditions, production equipment and profes
sional technicians commensurate with the medical devices produced by it.
(2) It has the institution or full-time inspectors and the inspection equipment for the quality in
spection of medical devices produced by it.
(3) It has management rules guaranteeing the quality of medical devices.
(4) It has the after-sales service capability commensurate with the medical devices produced
by it.
(5) It satisfies the requirements as prescribed in production research and development and pro
duction technique documents.
Article 8 To establish an enterprise engaging in the production of Class II or Class III medical
devices, the applicant shall file an application for production licensing with the local food and dru
g administration of the province, autonomous region, or municipality directly under the Central G
overnment, and submit the following materials:
(1) Photocopies of the business license and the organization code certificate.
(2) Photocopies of the registration certificate of and product technical requirements for the pr
oduced medical devices held by the applicant.
(3) Photocopies of the identity certificates of the legal representative and the person in charg
e of the enterprise.
(4) Photocopies of the identity, educational background and professional title certificates of t
he persons in charge of production, quality and technology.
(5) List of the educational background and professional titles of employees on production ma
nagement and quality inspection posts.
(6) Certification documents on the production premise, and the photocopies of certification d
ocuments on facilities and environment if there are special requirements for the production enviro
nment.
(7) List of major production equipment and inspection equipment.
(8) Quality manual and procedure documents.
(9) Process flow diagram.
(10) Authorization certificate for the handling person.
(11) Other certification materials.
Article 9 The food and drug administration of a province, autonomous region or municipality
directly under the Central Government shall, after receiving an application, handle the application
in light of the following circumstances respectively:
(1) The administration shall accept the application, if the subject matter of application falls u
nder its scope of functions, and the application materials are complete and conform to the statutory
form.
(2) If the application materials are incomplete or do not conform to the statutory form, the ad
ministration shall notify the applicant, on the spot or within five working days as of receipt of the
application materials, of all the necessary supplements and corrections at one time; and if the admi
nistration fails to do so within the prescribed time limit, the application shall be deemed accepted
on the date of receipt of the application materials.
(3) The administration shall allow the applicant to correct on the spot any error in the applicat
ion materials that can be corrected on the spot.
(4) The administration shall immediately make a non-acceptance decision, and notify the app
licant that it should file an application with the relevant administrative department, if the subject m
atter of application does not fall under its scope of functions.
Where the food and drug administration of a province, autonomous region or municipality dir
ectly under the Central Government makes a decision to accept or not to accept an application for
a medical device production license, it shall issue an acceptance or non-acceptance notice.
Article 10 The food and drug administration of a province, autonomous region or municipalit
y directly under the Central Government shall examine the application materials within 30 workin
g days after the date of acceptance, and conduct on-site verification according to the requirements
of quality management rules for medical device production. On-site verification shall be conducte
d according to the actual circumstances, and repeated verification shall be avoided. If rectification
is required, the time needed for rectification shall not be included in the time for examination.
If the prescribed conditions are met, the food and drug administration shall make a writt
en decision to approve licensing in accordance with law, and issue the Medical Device Production
License within ten working days; and if the prescribed conditions are not met, shall make a written
disapproval decision, and give an explanation on reasons.
Article 11 To establish an enterprise producing Class I medical devices, the applicant shall un
dergo the formalities for the recordation of Class I medical devices at the local food and drug admi
nistration at the level of a districted city, and submit the photocopy of the recordation certificate fo
r the produced medical devices held by the enterprise undergoing recordation and the materials as
set forth in Article 8 of these Measures (excluding item (2)).
The food and drug administration shall verify the integrity of the materials submitted by
the enterprise on the spot, grant recordation if the prescribed conditions are met, and issue the reco
rdation certificate for the production of Class I medical devices to the enterprise.
Article 12 Where an application for the production licensing of medical devices directly invol
ves the vital interest relationship between the applicant and any other party, the food and drug adm
inistration shall inform the applicant and the interested party of the right to apply for a hearing in a
ccordance with laws, regulations and the relevant provisions of the CFDA. Where the food and dr
ug administration deems that any major licensing matter involves public interest when examining
an application for the production licensing of medical devices, it shall make an announcement to t
he public and hold a hearing.
Article 13 A Medical Device Production License shall be valid for five years, indicating the l
icense number, enterprise name, legal representative, the person in charge of the enterprise, domic
ile, production address, production scope, license-issuing authority, date of issuance, validity term,
and other matters.
The Medical Device Production License shall include the registration form of produced medi
cal devices, indicating the name, registration number and other information of the produced medic
al devices.
Article 14 To increase new products, the medical device production enterprise shall submit th
e relevant materials involving modified contents as set forth in Article 8 of these Measures to the o
riginal license-issuing authority.
Where the products to be increased upon application do not fall under the original scope of pr
oduction, the original licensing-issuing authority shall conduct examination and on-site verificatio
n in accordance with Article 10 of these Measures, and if the prescribed conditions are met, modif
y the scope of production indicated in the Medical Device Production License, and indicate the pr
oduct information in the registration form of produced medical devices.
Where the products to be increased upon application fall under the original scope of pro
duction and have similar production technique, production conditions and other requirements with
the produced medical devices based on the original license, the original license-issuing authority s
hall examine the submitted materials, and if the prescribed conditions are met, indicate the product
information in the registration form of produced medical devices. If the requirements for the prod
uction techniques and production conditions of the said products have material difference with tho
se for the medical devices produced based on the original license, the original license-issuing auth
ority shall conduct examination and on-site verification in accordance with Article 10 of these Me
asures, and if the prescribed conditions are met, indicate product information in the registration for
m of produced medical devices.
Article 15 In the case of the non-literal modification of the production address, the applicant s
hall file an application with the original license-issuing authority for the modification of the medic
al device production license, and submit the relevant materials involving the modified contents as
set forth in Article 8 of these Measures. The original license-issuing authority shall conduct exami
nation and on-site verification in accordance with Article 10 of these Measures, and make a modifi
cation approval or disapproval decision within 30 working days. If a medical device production en
terprise establishes production premises across different provinces, autonomous regions or munici
palities directly under the Central Government, it shall file a separate application for the medical d
evice production license.