Regulatory Services
Our in-house team of locally employed regulatory affairs specialists, trained and experienced in medical devices, have registered and currently maintain 1000+ medical devices of all classes and all therapeutic areas from ophthalmics to orthopedics, cardiovascular to CNS, diabetes to diagnostics.
Product registration
All medical devices, whether manufactured domestically or imported, must be registered with the local regulatory authorities responsible for medical devices before they can be placed on the market. Each country has its own country-specific regulations, requirements and procedures for registration, importation, and distribution of medical devices and IVDs, even though Singapore, Malaysia, Indonesia, the Philippines, Thailand and Vietnam are all signatories to the ASEAN Medical Device Directive (AMDD) which has harmonized some elements such as the Common Submission Dossier Template (CSDT).
Local authorised representative
As a foreign manufacturer if you choose not to set up a foreign subsidiary in the target country, you will have to appoint a Local Authorised Representative (LAR) who will represent you in all dealings with the local medical device authorities. However, as each country has its own specific regulations concerning the LAR’s legal responsibilities and activities, you’ll need an on-the-ground team to liaise in person with the local authorities to ensure your company fulfils all the legal requirements on-time.
Post-market surveillance
Both you as a medical device manufacturer and your locally appointed dealers are required to carry out Post-Market Surveillance (PMS) to ensure the quality and evaluate the safety, performance, and effectiveness of your medical devices. With ASEAN member countries each introducing their own respective Post Marketing Alert Systems (PMAS), our local, in-house staff will help you maintain compliance in each country once your medical device is placed on the market.
Regulatory intelligence
All medical devices, whether manufactured domestically or imported, must be registered with the local regulatory authorities responsible for medical devices before they can be placed on the market. Each country has its own country-specific regulations, requirements and procedures for registration, importation, and distribution of medical devices and IVDs, even though Singapore, Malaysia, Indonesia, the Philippines, Thailand and Vietnam are all signatories to the ASEAN Medical Device Directive (AMDD) which has harmonized some elements such as the Common Submission Dossier Template (CSDT).