SINGAPORE Law and Practice Contributed by: Tony Yeo and Benjamin Gaw, Drew & Napier LLC
For Class C and Class D medical devices, there are also expedited routes. For example, the ECR-1 route is available for Class C medical devices that have approval from at least one of the HSA’s overseas reg- ulatory agencies, and that have been marketed for at least three years in the respective agencies’ juris- dictions, provided there are no safety issues globally and no prior rejection/withdrawal by the HSA or any overseas reference regulatory agencies. The ECR-2/ EDR route is available for Class C and Class D medi- cal devices that have approval from at least two of the HSA’s overseas regulatory agencies, and that have no prior rejection/withdrawal by the HSA or any overseas reference regulatory agencies. There are also immediate registration routes for Class B medical devices that meet certain conditions, and for Class B and Class C standalone medical mobile applications. Notwithstanding the above, there are some medical devices that do not qualify for the expedited routes, such as hip, knee and shoulder joint replacements, active implantable devices (eg, pacemakers, neuro- stimulators) and implantable devices in direct contact with the central circulatory system or central nervous system, among others. These devices will have to be registered via the full or abridged routes. Typically, the full route will take the longest time and have the highest fees, followed by the abridged routes, then the expedited route, and finally the immediate route (if applicable). Separately, there is also a Priority Review Scheme for Class B, C and D devices that are submitted under the full evaluation route (excluding Class D devices with a registrable drug in a secondary role). This is more expensive than going by the normal full evalu- ation route, but gives registrants the option to gain faster device registration and market entry for medical devices, with a 35% shorter turnaround time. If the medical device belongs to one of five focused healthcare areas (ie, cancer, diabetes, ophthalmic dis- eases, cardiovascular diseases, infectious diseases) and is designed and validated for an unmet clinical need, the fees associated with such an application
are lower than those for a medical device that does not meet these two criteria. 4.2 Regulatory Reliance Please see 4.1 Fast-Track Registration Routes . 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants Manufacturers of therapeutic products and medical devices are generally required to obtain a manufac- turer’s licence from the HSA. The manufacture of a health product means to make, fabricate, produce or process the health product, and includes: • any process carried out in the course of so mak- ing, fabricating, producing or processing the health product; and • the packaging and labelling of the health product before it is supplied. Manufacture of Therapeutic Products To issue a manufacturer’s licence, the HSA must be satisfied that the applicant is able to comply with the Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Guide to Good Manufacturing Prac- tice (GMP) for Medicinal Products in relation to the manufacture of the therapeutic product in question. The HSA enforces these standards by conducting pre- approval and routine GMP audits to ensure conform- ance to the standards. The details of the audit process may be found in the Regulatory Guidance published by the HSA on the Licensing, GMP Certification, and Inspection of Therapeutic Products Manufacturers in January 2022. If the therapeutic products contain controlled drugs or psychotropic substances, the respective licences will also have to be obtained. Manufacture of Medical Devices Applicants for a manufacturer’s licence are required to provide information on their Quality Management System through the submission of an ISO 13485 cer- tificate, the scope of which must include distribution
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