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Clause 2, Article 7

Conditions of medical equipment classifying employees:

a) Having qualified technical engineers, doctors and pharmacists according to the regulations of the Ministry of Education and Training.

b) Having at least 24 months’ experience of working in the field of medical equipment technologies at hospitals, medical facilities having beds, training institutions specified in medical equipment, facilities researching medical equipment, establishments producing medical equipment, organizations conducting the classification of medical equipment, agencies managing medical equipment (hereinafter referred to as “medical equipment facilities”) and without interruption for at most 5 years up to the date of submission of dossiers."

Conditions of medical equipment classifying employees:

a) Having qualified. Having at least a bachelor’s degree in technology or medicine/pharmacy;

b) Having at least 24 months’ experience of working in the field of medical equipment technologies at hospitals, medical facilities having beds, training institutions specified in medical equipment, facilities researching medical equipment, establishments producing medical equipment, organizations conducting the classification of medical equipment, agencies managing medical equipment (hereinafter referred to as “medical equipment facilities”) "

a) Amend “Having qualified technical engineers, doctors and pharmacists according to the regulations of the Ministry of Education and Training.” into “Having at least a bachelor’s degree in technology or medicine/pharmacy;”

b) Supplement “and without interruption for at most 5 years up to the date of submission of dossiers." in draft decree

clause 3, Article 7

No clause 3

Such organizations shall conduct the classification of medical equipment only when it has obtained the receipt note for the declaration of eligibility to classify medical equipment from the Ministry of Health according to provisions of point b clause 1 Article 9 of this Decree.

Remove clause 3, Article 7: Such organizations shall conduct the classification of medical equipment only when it has obtained the receipt note for the declaration of eligibility to classify medical equipment from the Ministry of Health according to provisions of point b clause 1 Article 9 of this Decree.

Clause 4, Article 14

A certificate of conformity with quality control standards.

A certificate of conformity with quality control standards.

In case of unavailability of the certificate of conformity with quality control standards, documents proving facilities satisfying requirements specified in clauses 1, 2, 3 and 4 Article 13 of this Decree are required.

In case the establishment fails to conduct the product quality inspection itself, or in case the establishment does not have storage facilities or transport vehicle and sign a contract with another establishment for quality inspection, storage and transport, documents proving that such contracting establishment is capable of conducting quality inspection, storing and transporting medical equipment produced by the producing establishment must be enclosed.”

Remove “In case of unavailability of the certificate of conformity with quality control standards, documents proving facilities satisfying requirements specified in clauses 1, 2, 3 and 4 Article 13 of this Decree are required.

In case the establishment fails to conduct the product quality inspection itself, or in case the establishment does not have storage facilities or transport vehicle and sign a contract with another establishment for quality inspection, storage and transport, documents proving that such contracting establishment is capable of conducting quality inspection, storing and transporting medical equipment produced by the producing establishment must be enclosed.”

Clause 1, Article 27

No Clause 1, Article 27

The application for reissuance of the free-sale registration number which is lost or damaged shall include an application form using the form No. 05 provided in Annex I enclosed with this Decree.

Remove The application for reissuance of the freesale registration number which is lost or damaged shall include an application form using the form No. 05 provided in Annex I enclosed with this Decree.

Point b, Clause 2, Article 27

No Point b, Clause 2, Article 27

A copy of the obtained certificate of free sale;

Remove A copy of the obtained certificate of free sale;