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.).

PP. Minister
Deputy Minister




Do Xuan Tuyen

LIST

...

...

...

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;

...

...

...

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):

...

...

...

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.

...

...

...

- 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.