Decree No. 169/2018/ND-CP dated December 31, 2018 of the Government on amendments to the Government's Decree No. 36/2016/ND-CP Dated May 15, 2016 on medical device management

THE GOVERNMENT 

Decree No. 169/2018/ND-CP dated December 31, 2018 of the Government on amendments to the Government's Decree No. 36/2016/ND-CP Dated May 15, 2016 on medical device management

Pursuant to the Law on Government Organization dated June 19, 2015;t

Pursuant to the Law on Investment dated November 26, 2014;

At the request of the Minister of Health;

The Government promulgates a Decree on amendments to the Government's Decree No. 36/2016/ND-CP dated May 15, 2016 on medical equipment management.

Article 1. Amendments to some Articles of the Government's Decree No. 36/2016/ND-CP dated May 15, 2016 on medical device management

1. Clause 1 of Article 2 is amended as follows:

“1. “medical device” means any instrument, apparatus, material, implant, reagent for in vitro use, software that satisfy all of the following requirements:

a) It is intended by the product owner be used, alone or in combination, for human beings, for one or more of the specific purpose(s) of:

- Diagnosis, prevention, monitoring, treatment or alleviation of disease, or compensation for an injury;

- Investigation, replacement, modification, or support of the anatomy or of a physiological process;

- Supporting or sustaining life;

- Control of conception,

- Disinfection of medical devices, including chemicals used in testing;

- Providing information serving diagnosis, monitoring or treatment through examination of specimens derived from the human body.

b) The device does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. The purposes mentioned in Point a of this Clause.”

2. Clause 6 of Article 3 is amended as follows:

“6. The sale of medical devices and raw materials for production medical devices that contain narcotic substances and precursors, in addition to requirements of this Decree, shall comply with regulations of law on drug control.”

3. Chapter II is amended as follows:

“Chapter II

CLASSIFICATION OF MEDICAL DEVICES

Article 4. Classes and rules for classification of medical devices

1. Medical devices are divided into 02 classes and 4 categories according to their potential risk level related to their designs and production:

a) Group 1 consists of Class A medical devices, which present low level of risk.

b) Group 2 consists of Class B, C, D medical devices. To be specific:

- Class B: Low–moderate risk.

- Class C: Moderate-high risk;

- Class D medical devices are those that present high level of risk.

2. Rules for classification of medical devices:

a) Classification of medical devices is risk based and implemented by an classifying organization that has declared its eligibility to categorize medical devices in accordance with this Decree;

b) In the cases where a medical device only has one purpose which present various levels of risks, the highest level of risk shall apply;

c) In the cases where a medical device has multiple purposes and each of which presents various levels of risks, the highest level of risk shall apply;

d) When a medical device is used in combination with another medical device, each of them may present a different level of risk but the classification shall be based upon the highest level of risk of the final purpose of such combination.

3. The Minister of Health shall specify classification of medical devices in accordance with ASEAN's treaties on classification of medical devices to which Vietnam is a signatory.

Article 5. Classifying organizations

1. Classification of medical devices shall be implemented by organizations that satisfy the conditions specified in Article 7 of this Decree.

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