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.
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.
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.
It can be a challenge to understand the full extent of the regulatory landscape for your medical device or IVD in foreign markets, especially if you don’t speak the language. Obtaining a regulatory intelligence report from our local regulatory affairs specialists will help you navigate all the regulatory complexities of getting your product to market, from document compliance screening and gap analysis to labelling and (pre)clinical testing requirements, from market access licences to fast-track authorisation possibilities.
The medical device and IVD markets in Southeast Asia are growing rapidly, which means each country needs to either introduce or update legislation and regulatory requirements to govern the sector so ensuring the safety and efficacy for end users. To help you better navigate the medical device regulatory pathways, Andaman Medical has developed a series of six on-demand online learning covering Singapore, Malaysia, Indonesia, the Philippines, Thailand and Vietnam.