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MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 7395/BYT-TB-CT
Re: applications for medical device registration
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Hanoi, December 31, 2020
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To: Applicants
for medical device registration
(hereinafter referred to as “applicants”)
Pursuant to the Government’s Decree No. 36/2016/ND-CP
dated 15/5/2016 on medical device management (hereinafter referred to as
“Decree No. 36/2016/ND-CP”), the Government’s Decree No. 169/2018/ND-CP
dated 31/12/2018 amending some Articles of Decree No. 36/2016/ND-CP (hereinafter
referred to as “Decree No. 169/2018/ND-CP”), the Government’s Decree No.
03/2020/ND-CP dated 01/01/2020 amending Article 68 of Decree No. 36/2016/ND-CP (hereinafter
referred to as “Decree No. 03/2020/ND-CP”), and Circular No. 46/2017/TT-BYT
dated 15/12/2017 by the Minister of Health on guidelines for Decree No.
36/2016/ND-CP (herein after referred to as “Circular No. 46/2017/TT-BYT”).
Recently, the Ministry of Health has received,
processed and appraised applications for medical device registration (hereinafter
referred to as “registration applications”) and provided Official
Dispatches and guidelines to assist you with preparing these applications
according to regulations.
In order for you to understand and comply with
regulations properly and accelerate appraisal of registration applications
according to regulations of Decree No. 36/2016/ND-CP, Decree No. 169/2018/ND-CP
and Decree No. 03/2020/ND-CP, the Ministry of Health would like to request you
to perform the following tasks:
1. Regularly check your
accounts and email addresses to follow the application appraisal process on the
online public service system for medical device management (hereinafter
referred to as “online public service system”).
2. Study regulations in
Article 25 and Article 26 of Decree No. 36/2016/ND-CP and Decree No.
169/2018/ND-CP and instructions of use uploaded onto the online public service
system to submit the appropriate application following the correct procedure.
Ex: apply for registration of a medical device
without applicable national technical regulations following the procedure for
medical devices with national technical regulations; submit an ineligible
application following the procedure for quick issuance of registration number.
3. Review compliance of
components of your applications such as ISO certificate, certificate of free
sale, letter of authorization, etc. submitted to the online public service
system with regulations in Articles 26 and 28 of Decree No. 36/2016/ND-CP and
Decree No. 169/2018/ND-CP to prepare to update expired documents at the request
of application appraisal specialists.
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- The scope written on the certificate must
specify the medical device applying for registration number. E.g., the scope of
the certificate included in an application for registration of an ultrasound
machine must specify the factory manufacturing the machine.
5. Regulations on
supplement to registration applications:
a) Review your registration applications on the
online public service system and comply with regulations in Article 29 of
Decree No. 36/2016/ND-CP and Decree No. 169/2018/ND-CP: if you fail to revise
your applications within 90 days starting from the date upon which the Ministry
of Health requests you to do so in writing or your applications are still
unsatisfactory after 05 supplementation times, the registration procedures will
be restarted.
b) Remove registration applications that you no
longer wish to be considered or are unable to complete.
6. Regarding medical device
classification form: review your medical device classification forms and ensure
that these forms are published on the web portal of the Ministry of Health
according to regulations in Point c Clause 5 Article 66 of Decree No.
36/2016/ND-CP and Decree No. 169/2018/ND-CP, excluding classification results
included in registration applications submitted prior to 01/9/2019 according to
regulations in Circular No. 42/2016/TT-BYT dated 15/11/2016 by the Ministry of
Health.
7. Study regulations on
grouping of medical devices in Circular No. 39/2016/TT-BYT dated 28/10/2016 by
the Ministry of Health on classification of medical devices when preparing
registration applications to minimize number of applications and reduce
pressure of application appraisal on the competent authority.
8. Declare information in
your registration applications following the guidance provided in Appendix I (attached
document).
Any difficulty arising during registration
application submission should be reported to the Ministry of Health (Department
of Medical Equipment and Construction), phone number: 024.62732272, email: [email protected]
for consideration and guidance on resolution.
For your reference and compliance./.
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P.P. MINISTER
DIRECTOR GENERAL
DEPARTMENT OF MEDICAL EQUIPMENT AND CONSTRUCTION
Nguyen Minh Tuan
APPENDIX I
SOME GUIDELINES
ON DECLARATION OF INFORMATION IN APPLICATIONS FOR MEDICAL DEVICE REGISTRATION
1. Applications
for new registration number:
a) Declare full and accurate information on the
applicant’s name (including tax identification number, address, phone number
and email) and information on the applicant’s legal representative as written
on the enterprise certificate/ investment certificate.
b) Name of medical device:
- Declare information in Vietnamese and
lowercase (no capitalization, no English name, commercial name, brand name,
code or type or combination of names of multiple medical devices).
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+ Names of in-vitro diagnostic medical devices
must include the following information:
1. Product type: reagent/ calibrator/ control/
kit/ test tray/ test strip/ electrode/ card.
2. Test type: qualitative/ quantitative/
semi-quantitative.
3. Analytical parameters/ analyte.
In addition, there are some support products
such as in-vitro diagnostic medical devices for lysis-based testing; in-vitro
diagnostic medical devices for fluorescence testing, etc.
E.g., incorrect name: “Chemical_diagnosis_HIV
=> correct name: HIV qualitative reagent; incorrect name: Immuno testing
chemical_for testing_syphilis => correct name: Treponema pallidum
qualitative reagent; incorrect name: Chemical_detection_ SARS-CoV-2 IgG
antibodies => correct name: SARS-CoV-2 IgG antibodies qualitative test
kit.
+ For medical devices besides in-vitro
diagnostic medical devices: e.g., incorrect name: Guide wire => correct
name: Guide wire used for cardiovascular intervention; incorrect name: Medical
material used in dentistry => correct name: Dental implant.
- For applications for registration of a medical
device as a part of a kit/ cluster/ group/ family/ system, the medical device’s
name must abide by rules for grouping of medical devices in Circular No.
39/2016/TT-BYT dated 28/10/2016 by the Ministry of Health on classification of
medical devices.
c) Type:
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- For applications for registration of medical
devices of different types and product codes, list the types based on product
code and packaging specification (if any).
- Declare the class of medical devices of classs
B, C and D in a correct manner based on medical device classification forms the
results of which have been published on the online public service system by
facilities eligible for medical device classification. The medical device
classification form must specify whether a medical device is registered as a
part of a kit/ cluster/ group/ family/ system.
d) The country/ies in addresses of the
manufacturing facility, warranty service providers, medical device owner and
applicant shall be written in a consistent manner.
e) Name of manufacturing facility and address of
manufacturing facility: declare full and accurate information as written on the
certificate of conformity with ISO 13485 standard or certificate of free sale
of imported product.
g) Information on product owner: declare full
and accurate information as written on the certificate of free sale of imported
product.
2. Catalogues:
a) For applications for registration of medical
devices besides in-vitro diagnostic medical devices domestically manufactured:
applicants shall provide the documents mentioned in Article 26 of Decree No.
36/2016/ND-CP and Decree No. 169/2018/ND-CP, and study and adhere to
regulations of Decree No. 46/2017/TT-BYT.
b) For applications for registration of a
medical device as a part of a kit/ cluster/ group/ family/ system: applicants
shall provide a separate catalogue for each product type or one consolidated
catalogue with reference or link to the page/section corresponding to each
product type.
c) Catalogues shall include full information and
not refer to other documents (e.g., do not write “Refer to attached
instructions for use”), unless the information could not be summarized or is
too long (e.g., preclinical, clinical, manufacturing process, etc. sections).
If a catalogue has multiple appendixes, each part shall have a heading and
table of contents.
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Instructions for use shall include the following
basic information: intended purposes/ indications, contraindications (if any),
warnings, precautions, adverse effects (if any), administration, information on
diagnostic efficiency for in-vitro diagnostic medical devices and storage
conditions and use conditions necessary for maintenance of safety and
effectiveness of medical devices.
4. Label
specimens:
a) Labels shall adhere to regulations of the
Government's Decree No. 43/2017/ND-CP dated 14/4/2017 on goods labels.
b) For original labels: specimens of labels of
every product type and packaging specification, including container labels,
secondary container labels, etc., shall be provided. In case of application for
registration of a medical device as a part of a family, applicants may submit
the common label used for the whole family and specify which information on the
label is replaceable.
5. Attached
files:
a) Scan documents included in your applications
in color. All pages of notarized copies shall be scanned with the notary seal
stamped on each page or over the fanned edges of the pages.
b) Add all scanned pages of a document into one
file in the correct order and name the file according to the document’s content.
E.g., certificate of free sale, certificate of conformity with ISO 13485
standard, letter of authorization, etc.
c) If the certificate of free sale has multiple
pages, scan all pages and mark which product is applying for registration
number.
d) Do not upload files irrelevant to your
registration applications.