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MINISTRY OF
HEALTH OF VIETNAM
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
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No. 2098/BYT-TB-CT
Re. Reviewing and inspection of medical
device declaration procedures
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Hanoi, April 12,
2023
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To:
Departments of Health of provinces and central-affiliated cities
(hereinafter referred to as "Departments of Health")
Implementing Decree No. 36/2016/ND-CP dated May 15,
2016, and Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on
medical device management (hereinafter written abbreviated as “Decree No.
36/2016/ND-CP, Decree No. 98/2021/ND-CP”), the Departments of Health have
implemented procedures for declaration of eligibility for manufacture of
medical devices, procedures for declaration of eligibility for trading of
Class-B, Class-C or Class-D medical devices and procedures for declaration of
applied standards of Class-A or Class-B medical devices on the online public
service system on medical device management at https://dmec.moh.gov.vn.
To strengthen post-inspection of the implementation
of medical device declaration procedures at the Departments of Health, promptly
handle violations (if any) as per regulations; Departments of Health must
urgently implement the following tasks:
1. Departments of Health shall review and inspect
declarations of applied standards of Class-A or Class-B medical devices as
follows:
a) The products to be declared must be consistent
with the definition of “medical device” according to the provisions of Decree
No. 36/2016/ND-CP, and Decree No. 98/2021/ND-CP. Declarations of applied
standards of products that are not consistent with the definition of
"medical device" must be reviewed. The products may be cosmetics,
traditional medicines, herbal medicines, pharmaceutical chemicals, etc.).
b) Components of declarations must be sufficient
according to the provisions of Decree No. 36/2016/ND-CP, and Decree No.
98/2021/ND-CP, where:
- Regarding imported medical devices: Declarations
that are submitted from December 31, 2018 shall include the Certificate of Free
Sale (CFS) as prescribed.
- Regarding medical devices manufactured in
Vietnam: A declaration of applied standards must include a note of
receipt of declaration of eligibility for manufacture or number of declaration
of eligibility for manufacture of medical devices.
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Departments of Health shall review and inspect
declarations of applied standards of class-A or class-B medical devices
according to the above-mentioned contents and revoke declaration numbers
according to regulations in case of violations. (A list of products
subject to review of declarations of applied standards of class-A or class-B
medical devices is enclosed with).
2. Departments of Health shall review and
inspect components of declarations of eligibility for trading of class-B,
class-C, or class-D medical devices according to the provisions of Decree No.
36/2016/ND-CP, Decree No. 98/2021/ND-CP and revoke notes of receipt of
declarations or information on declaration in some cases: Components of
declarations are insufficient (E.g. A declaration does not include documents
proving storage facilities, means of transporting medical devices, etc.); lists
of names or groups of medical devices to be traded or products that are
declared to be eligible for trading but are inconsistent with the definition of
“medical device”, etc. are not specified on declarations.
3. Departments of Health shall review and
inspect components of declarations of eligibility for manufacture of medical
devices according to the provisions of Decree No. 36/2016/ND-CP, Decree No.
98/2021/ND-CP and revoke notes of receipt of declaration or information on
declaration in some cases: Components of declarations are insufficient (E.g.
A declaration does not include a Certificate of conformity with ISO 13485
quality control standards, etc.); the Certificate of conformity with ISO
13485 quality control standards is invalid: (i) The organization issuing such
certificates have not successfully registered in Vietnam according to the
provisions of Decree No. 107/2016/ND-CP dated July 01, 2016 of the Government
on conditions for provision of conformity assessment services, (ii) scope of
product production stated on the Certificate of conformity with ISO 13485
quality control standards is not consistent with the medical device declared
eligible for production, (iii) product within the scope of production stated on
the Certificate of conformity with ISO 13485 quality control standards is
inconsistent with the definition of “medical device", etc.
Departments of Health shall review and inspect
medical device declarations, and revoke declaration numbers, notes of receipt
of declaration or information on declaration in case of violations; submit
reports on their actions against cases of violations to the Ministry of Health
(via the Department of Medical Equipment and Works) to have a basis for their
cooperation with relevant units in handling./.
PP. Minister
Deputy Minister
Do Xuan Tuyen
LIST
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I. Products that are inconsistent with the
definition of “medical device”:
1. Shampoo/Conditioner;
2. Shower and shampoo cream/shower and shampoo
gel/hair and body wash/Makeup remover;
3. Facial cleanser/Body lotion;
4. Skin peeling and exfoliating products;
5. Feminine hygiene solution/Gynaecological hygiene
solution/Men's hygiene solution;
6. Hand sanitizer gel/hand rub/hand sanitizer
cream/hand disinfectant;
7. Essential oil; Medicated oil; Camellia oil;
Tamanu oil; Coconut oil; therapeutic essential oil for flu;
8. Ethanol used for disinfecting wounds/ Hydrogen
peroxide;
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10. Insect repellent solution; Mosquito repellent
oil; Mosquito repellent spray; Mosquito repellent patch; Warming,
cough-relieving and mosquito repellent cream;
11. Inhalation capsules, powders, herbs; inhalation
herbs for private parts; hemorrhoid soaking and inhalation; inhalation herb
extracts;
12. Foot soak powder; Effervescent tablets for foot
bath; Foot bath solution; salt and medicinal herbals for foot bath; medicinal
ingredients for foot bath; Herbals for foot bath;
13. Lozenges;
14. Toothpaste;
15. Motion sickness patches;
16. Products containing Urea C13 and Urea C14
markers;
17. Medicine decoction machines.
II. Products that may be inconsistent with
the definition of “medical device” (it is required to review the active
ingredients, mechanism of action of products and rules for classification of medical
devices):
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2. Products for external use; Massage solution for
external use; ointment for external use; poultices;
3. Suppositories for medical treatment;
Gynecological suppositories; Vaginal suppositories; Rectal suppositories;
Rectal suppositories; anal-rectal suppositories;
4. Beauty equipment.
III. Products that are not suitable for
classification as class-A or class-B medical devices due to their intended
uses:
1. Some in vitro diagnostic medical devices (hereinafter
abbreviated as IVDs), although classified as class-A medical devices (in
declarations of applied standards of class-A medical devices), are not suitable
for classification as class-A medical devices due to their intended uses, E.g. Pregnancy
test strips; ovulation test kits; test kits for qualitative detection of
SARS-CoV-2 neutralizing antibodies; Mycobacteria Real-time PCR Detection Kits;
M. Tuberculosis Drug Resistance Gene Real-Time PCR Detection Kits, etc.
2. Some IVDs, although classified as class-A or
class-B medical devices (in declarations of applied standards of class-A or
class-B medical devices), are not suitable for classification as class-A or
class-B medical devices due to their intended uses:
- The IVD intended to be used to determine blood
type, e.g. Blood grouping reagents.
- The IVD intended for use in HIV testing, e.g. Test
tray for qualitative testing of antibodies to HIV-1 and HIV-2 in human blood
samples.
- The IVD intended for use in HBV testing, e.g. HBV
rapid tests; IVD kits for determination of concentrations of hepatitis B
surface antigens (HBsAg) in the blood; Test trays used in qualitative detection
of hepatitis B surface antigens (HBsAg) in serum or plasma.
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- The IVD intended for use in Dengue virus testing,
e.g. Test trays for the qualitative detection of Dengue NS1 antigen;
test trays for the qualitative and differential detection of IgM and IgG
antibodies against dengue virus; Dengue virus test strips/test trays; test kits
for the qualitative detection of Dengue NS1 Antigen; test kits for the
qualitative detection of both Dengue Ab (IgG/IgM) and NS1 Ag.
- The IVD intended to be used to test for Influenza
A and B, e.g. Influenza A/B antigen rapid test trays; Rapid test for the
qualitative detection of influenza A and influenza B antigens; Chemicals used
in qualitative tests of Influenza A and B and respiratory syncytial virus (RSV)
RNA.
- The IVD intended to be used to detect the
presence of sexually transmitted agents, e.g. Rapid diagnostic medical
devices for the detection of presence of syphilis antibodies in plasma or
serum; Chemicals used in quantitative tests for syphilis; Syphilis test kits;
Syphilis rapid test strips; HPV High-risk Types with 16,18 Test Kits.
- The IVD intended to be used to monitor
concentrations of substances or biological components where erroneous test
results could lead to an immediate life-threatening risk to the patient due to
inappropriate treatment decisions, e.g. Chemicals contained in CK-MB test
kits; Test trays used for the qualitative detection of Troponin I in serum and
plasma; IVD Clusters - Cardiac markers: TnI, BNP, MYO, CK-MB; General blood
coagulation tests: Activated partial Thromboplastin time (APTT) tests.
- The IVD intended to be used for on-site testing
of blood glucose parameters, e.g. Personal blood glucose meters.