IN exercise of the powers conferred by section 77 of the Medical Device Act 2012 [Act 737], the Minister makes the following order:
1. Citation · Citation
This order may be cited as the Medical Device (Exemption) Order 2024.
2. Interpretation · Interpretation
In this Order— “demonstration for marketing” means a marketing activity which includes promotions, exhibitions, scientific symposia or surveys, which do not involve the use of medical device on human; “clinical research” means any systematic investigation or study that determines the safety and effectiveness of medications, devices, diagnostic products, medical procedures and treatment regimens intended in or on one or more human subjects, in an adequate human clinical environment; “personal use” means a medical device which is brought into Malaysia for the use of a particular individual only and not to be placed in the market or be used on a third party; “education” means the process of teaching, training or educating the public not for the purpose of promoting or marketing, and not to be used any medical device on human; “special access medical device” means a medical device for the use of medical practitioners in emergency situations or in the event that conventional medical treatment has failed, is unavailable or unsuitable; “obsolete medical device” means an existing medical device in a Government and private healthcare facilities and services, wellness centres or any related facilities which is outdated and no longer being manufactured due to design changes or evolution of new technologies; “custom-made medical device” means a medical device that has been designed and manufactured in accordance with a written prescription from a qualified medical practitioner for the sole use of a particular patient but not including mass produced medical devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user; “discontinued medical device” means an existing medical device in a Government and private healthcare facilities and services, wellness centres or any related facilities that is no longer in the distribution; “orphaned medical device” means an existing medical device in a Government and private healthcare facilities and services, wellness centres or any related facilities where the manufacturer or authorized representative has ceased operation.
3. Exemption from registration of medical devices · Exemption from registration of medical devices
(1) The Minister exempts any medical device from the registration under section 5 of the Act if the medical device is— (a) for the purposes of personal use; (b) for the purposes of demonstration for marketing; (c) for the purposes of education; (d) for the purposes of clinical research; (e) for the purposes of performance evaluation of medical device; (f) for the purposes of export only; (g) for the purposes of import for re-export; (h) a custom-made medical device; (i) a special access medical device; (j) an orphaned medical device; (k) an obsolete medical device; or (l) a discontinued medical device. (2) The exemption under subparagraph (1) is subject to the following conditions: (a) any person who imports, exports, manufactures or place in the market any medical device under subsubparagraph (1)(b), (c), (d), (e), (f), (g), (h) or (i) shall make an application for an exemption to the Authority in the form and manner as determined by the Authority; (b) the exempted medical devices under subsubparagraphs (1)(a), (j), (k) and (l) shall be dealt in the form and manner as determined by the Authority.
4. Exemption from establishment licence · Exemption from establishment licence
The Minister exempts a person who imports or exports any medical device referred to in paragraph 3 excluding a special access medical device from the requirement of an establishment licence under subsection 15(1) of the Act.
5. Exemption from conformity assessment for Class A medical device · Exemption from conformity assessment for Class A medical device
The Minister exempts a Class A medical device from the conformity assessment procedures by a conformity assessment body under section 7 of the Act.
6. Revocation and saving · Revocation and saving
(1) The Medical Device (Exemption) Order 2016 [P.U. (A) 103/2016] is revoked. (2) Any exemption made under the Medical Device (Exemption) Order 2016 before the date of coming into operation of this Order shall, on the date of coming into operation of this Order, continue to be in force until amended or revoked. Made 20 February 2024 [KKMMDA(S)100/1-1-1; PN(PU2)711/V] DATUK SERI DR. HAJI DZULKEFLY BIN AHMAD Minister of Health