Overview of the Medical Device Act 2012

1. The objective of the Medical Device Act 2012 is to give powers to the Ministry of Health
and the Medical Devices Authority to regulate on establishments (ie. Manufacturers,
Distributors, Importers), medical devices, Conformity Assessment Bodies ("CAB"), and
users.
2. The 2012 Act mainly covers the following:
a. Registration;
b. Licence and Permits;
c. Appeals; and
d. Enforcement.
Relevant definitions
3. Establishment
"a person who is either a manufacturer, importer or distributor who places any medical
device in the market, but does not include a retailer; and an authorised representative
appointed by a manufacturer having a principal place of business outside of Malaysia.
Such authorised representative must be a person domiciled/resident in Malaysia or a
firm/company constituted under the laws of Malaysia and carrying business in Malaysia"
4. Manufacturer
a person who is responsible for:
the design, production, fabrication, assembly, processing, packaging and
labelling of a medical device whether or not it is the person, or a
subcontractor acting on the persons behalf, who carries out these
operations; AND
assigning to the finished medical device under his own name, its intended
purpose and ensuring the finished product meets the regulatory
requirement; or
any other person who:
assembles, packages, processes, fully refurbishes, reprocesses or labels
one or more ready-made medical devices; and
assigning to the ready-made medical device under his own name, its
intended purpose and ensuring the finished product meets the regulatory
requirement,
but shall NOT INCLUDE the following:
any person who assembles or adapts medical devices in the market that
are intended for individual patients; and
any person who assembles, packages or adapts medical devices in
relation to which the assembling, packaging or adaptation DOES NOT
change the purpose intended for the medical devices
*Manufacturers have obligations to comply with under Section 4 of the 2012 Act and
Regulation 4 of the Medical Device Regulations ("MDR").
Registration
5. The Act deals with two types of registrations, namely i) registration of the medical device
and ii) registration of the CAB.
6. Registration for medical devices:
a. Medical devices have a specific definition afforded under Section 2 of the Act.

b. Section 5 states that no medical device shall be imported, exported or placed in

the market without registration. Failure to do so carries a fine of RM200,000 or 3
years imprisonment or both.
c. Section 6 specifies the application for registration but Regulation 5 of the MDR
details the procedural requirements.
d. Section 8 allows the Medical Devices Authority to grant conditions on the
registration.
e. The registration process for medical device is summed up in the Figure 1 below:

Figure 1
7. Registration for CAB
a. Section 10: A CAB has to be a body registered under the Act to carry out
assessments;
b. Person responsible of the assessment has to be a Malaysian citizen;
c. CAB shall be independent.
d. Section 11: Application for registration must be made in writing in the prescribed
manner.
Conformity Assessment ("CA")
8. The CA procedure is set out in the Third Schedule of the MDR 2012. Briefly, the CA is
conducted to provide objective evidence of conformity/compliance to
a. the Essential Principles of Safety and Performance for Medical Devices (EPSP)
b. the Medical Device Act 2012 and its subsidiary legislations.
9. The elements of CA include:
a. Quality management system (QMS);
b. Post-market surveillance (PMS) system;
c. Summary technical documentation (CSDT);
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d. Declaration of conformity (DoC).

10. The Authority verifies evidence of conformity during registration of medical device and
licensing of establishment (see below).
Licence and Permit
11. The Act specifies that:
a. all establishments need to register for an establishment licence; and
b. persons using/operating designated medical devices need to hold designated
medical device permit.
12. For Establishment Licences (placement on-market):
a. After CA, establishments like manufacturers/importers/distributors shall apply for
the licence to import/distribute medical devices.
b. The license can be granted with conditions, subject to renewals and cannot be
assigned to a third party without approval from the Medical Devices Authority.
c. The registration can be done through the Medical Devices Centralised Online
Application System.
13. For Designated Medical Device Permit:
a. Only operation of medical devices specified by the Minister published on the
Gazette is required to hold this permit.
b. Section 28 states that the application must be made in writing to the Medical
Devices Authority.
c. The permit can be granted with conditions and subject to renewals.
14. Export Permit:
a. Section 45: An establishment may apply to the Authority for a permit to export a
registered medical device in the prescribed form and accompanied by the
prescribed fees;
b. Regulation 15 MDR 2012: Requirement that the establishment must be licensed
and the medical device must be registered.
Statutory duties
15. Establishment licensees (post-market):
a. Section 37: maintain distribution records as prescribed by the Minister;
b. Section 38: carry out post-market surveillance to monitor safety and performance
of the product and record and evaluate any adverse reports;
c. Section 39: handle complaints;
d. Section 40: mandatory reporting to the Medical Devices Authority if the medical
device causes death, is defected or poses a serious threat to public health.
e. Section 41: undertake field corrective actions;
f. Section 42: undertake product recall for defective devices.
16. Section 43: General duty:
a. Usage, operation, maintenance, etc. of medical devices
i. Standard of use when operating on a third party;
ii. Qualification/competence when using device;
iii. Take out of operation when no longer safe to use;
iv. Be removed and disposed of safely;
v. Observe Medical Devices Authority's guidelines/directives on best
practices;
17. Section 44: prohibited to advertise the medical device if it is not registered/compliant with
the Act. Prohibition of fraudulent advertisements.
Appeal

18.Section 47: Any person aggrieves by the decision of Authority may appeal to the Minister
in the prescribed manner and period.