Provision on the Maltese Market Regulations, 2020

L.N. 321 of 2020

MEDICINES ACT

(CAP. 458)

Medical Devices and In-Vitro diagnostic Medical Devices

Provision on the Maltese Market Regulations, 2020

IN EXERCISE of the powers conferred by article 106(r) and (s)

of the Medicines Act, the Minister responsible for Health, after

consultation with the Medicines Authority, has made the following

regulations:-

The title of these regulations is the Medical Devices and In- Citation.

Vitro diagnostic Medical Devices Provision on the Maltese Market

Regulations, 2020.

For the purposes of these regulations, unless the context Interpretation.

otherwise requires

"Act" means the Medicines Act;

"authorisation" means the approval given by the competent

authority or any other authority as may from time to time be

prescribed;

"competent authority" means the Medicines Authority as

established under article 4 of the Medicines Act;

"economic operator" means a manufacturer, an authorised

representative, an importer or a distributor of medical devices;

"medical device" means any medical device as defined in

paragraph 1 of Article 2 of Regulation (EU) 2017/745, and any in-

vitro diagnostic medical device as defined in paragraph 2 of

Article 2 of Regulation (EU) 2017/746 and shall include any

product designated as such by the competent authority;

"Minister" means the Minister responsible for public

health;

"premises" means the location of the storage of medical

devices and in-vitro medical devices;

"public health" and "public health emergency" shall have

the same meaning as assigned to them by article 2 of the Public Cap. 465.

Health Act;

"public health risk" shall have the same meaning as

assigned to it by article 2 of the Public Health Act;

"medical device registered person" means any person who is

responsible for medical devices in terms of regulation 6;

"national medical device database" means the

collection of data or other materials in relation to medical

devices which are arranged in a systematic or methodical

order and which are individually accessible by electronic

or other means;

"non-conforming medical device" means any medical device

that does not fulfill its specified requirements as required by or

under these regulations or any other law;

"superintendent" means the Superintendent of Public

Health as established by article 3 of the Public Health Act.

The competent authority is designated under these

regulations

(a) as the authority in charge of regulating and ensuring

compliance and adherence to the applicable local and international

laws that apply to medical devices; and

(b) as the authority responsible for designation and

supervision of notified bodies concerned with medical devices in

Malta.

The administration of these regulations shall be vested in the

Minister or such other person, agency or authority so delegated by the

Minister for any of the purposes of these regulations.

(1) No person shall carry out importation, wholesaling,

manufacturing or re-purposing in Malta of any medical device which is

intended for trade within the European Union and, or the local market

prior to obtaining all the necessary approvals, authorisations, licences,

permits and, or any notification/s as required by or under these

regulations or any other law.

(2) Any person intending to carry out any of the activities

identified in sub-regulation (1) shall

(a)

comply with the provisions of these regulations;

(b) comply with all national and European Union

regulations, including international obligations resulting from

any treaty to which Malta may from time to time be a part of, as

may be applicable;

(c) obtain the necessary authorisation from the competent

authority;

(d) possess the necessary qualifications and have

undergone any necessary training as may be required by the

competent authority;

(e)

comply with any other applicable law;

(f)

have a medical device registered person in Malta; and

(g) insert details of all medical devices which he markets

locally in the national medical device database kept by the

competent authority.

(1) No person shall act as a medical device registered Obligation for

person responsible for any medical device locally unless they have medical

registered person.

registered as such with the competent authority.

(2) Any person who applies for registration as a medical device

registered person shall satisfy any eligibility requirements as may be

established by the competent authority.

(3) Any person registered as a medical device registered person

with the competent authority shall be issued a registration document.

(1) The issuing of any approval by the competent Issuing of

approval.

authority pursuant to these regulations shall be subject to

(a) the submission by the applicant and the evaluation of

documents, including due diligence documentation, and any other

information as may be deemed necessary in order to ensure

fulfilment of the authorisation requirements; and

(b) the attainment by the applicant of any authorisation,

licence, permit, approval and clearance from the competent

authority or any other entity as may be prescribed under these

regulations or any other legislation that may be applicable from

time to time

Provided that the competent authority may, at its own

discretion, request any additional information it deems necessary

for the evaluation of the application.

(2)

The withdrawal, revocation, cancellation or expiry of any

authorisation issued pursuant to these regulations shall preclude the

holder thereof from carrying out the relevant activity.

The competent authority may issue guidelines and, or

directives for establishing any other matter, including but not limited to

the level of security considered necessary or expedient for the carrying

out of any of the provisions of these regulations.

(1) The competent authority shall monitor and review

any operations conducted within premises with a view to ensuring that

any operation within the scope of these regulations is carried out in

accordance with the provisions of these regulations and in compliance

with any decision that may be lawfully taken pursuant to these

regulations or any other applicable legislation.

(2) For the purposes of this regulation, the competent authority

or any person so authorised shall have the right at all reasonable times

and, where necessary, with the assistance of the Executive Police to

enter and inspect any premises.

(1) Any economic operator that has received complaints or

reports from healthcare professionals, patients or users about incidents

related to a medical device which they have made available on the local

market, shall immediately forward this information to the competent

authority.

(2) Every economic operator shall keep a register containing

details of complaints, of non-conforming medical devices and of recalls

and withdrawals of medical devices, and shall keep the competent

authority informed of such monitoring.

(3) The competent authority may request any other information

from any person or entity as it may deem necessary for the carrying out

of its functions pursuant to these regulations.

Any person who contravenes any provision of these

regulations shall be guilty of an offence and shall on conviction be

subject to a fine (multa) of not less than twelve thousand euro (€12,000)

and not exceeding one hundred and twenty thousand euro (€120,000) or

to imprisonment for a term not exceeding two (2) years, or to both such

fine and imprisonment.

€0.36