SINGAPORE Law and Practice Contributed by: Tony Yeo and Benjamin Gaw, Drew & Napier LLC
of the categories of medical devices and the activities performed, a Medical Device Single Audit Program (MDSAP) certificate, or a declaration of conformity to a Quality Management System (for companies dealing with Class A medical devices only). A manufacturer’s licence is not required for certain activities, including: • manufacture at the request of a qualified practition- er practising at the licensed healthcare institution intended for the use of a particular patient of the licensed healthcare institution; • manufacture by way of fitting or adjusting the medical device to meet the requirements of the end user; • manufacture to enable the continued use of the medical device by the end user; • secondary assembly where the company holds an importer’s licence or wholesaler’s licence and is able to comply with the requirements of the Good Distribution Practice Standard for Medical Devices or ISO 13485; • manufacture for use in clinical research; • manufacture of laboratory-developed tests; • manufacture of Class A medical devices for a charitable purpose; or • manufacture of specified dental medical devices. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices Establishments are generally required to obtain a wholesaler’s licence from the HSA in order to engage in the wholesale of therapeutic products and medical devices. The wholesale of a health product includes the supply of the product: • to a person who obtains the product for the pur- poses of supplying it to another person; • to a person as a commercial sample in the normal course of a lawful trade; • to the Singapore government where it is required for the purposes of public service or use in con- nection with the exercise of any statutory power;
• to a person or an institution concerned with sci- entific education or research requiring the health product for such a purpose; • to a person who requires the health product for the purpose of complying with any written law with respect to the medical treatment of individuals employed by that person in any business or trade carried out; • to a person who requires to use the health product, other than by way of administration to one or more individuals, for the purpose of business or trade; or • by export to a party outside Singapore. Wholesale of Therapeutic Products To obtain a wholesaler’s licence for therapeutic prod- ucts, the establishment must first be audited to com- ply with the HSA’s Good Distribution Practice stand- ards, which are set out in the HSA’s Guidance Notes on Good Distribution Practice, revised in December 2023. Where the establishment intends to export codeine cough preparations or therapeutic products contain- ing psychotropic substances, additional approval must first be obtained from the HSA. Certain activities may not require a licence if the exceptions available in the Health Products (Thera- peutic Products) Regulations 2016 apply. Wholesale of Medical Devices To be granted a wholesaler’s licence for medical devices, the establishment is generally required to submit any of the following to the HSA: • an ISO 13485 certificate, the scope of which must include distribution of the categories of medical devices and the activities performed at the facility, where applicable; • Medical Device Single Audit Program (MDSAP); • a declaration of conformity to a Quality Manage- ment System (for companies dealing with Class A medical devices only); or • a Good Distribution Practice Standard for Medical Devices certificate issued by a certification body accredited by the Singapore Accreditation Council, or a declaration of exemption thereof.
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