The ASEAN Medical Device Directive. Should Orthotic and Prosthetic companies entering the South East Asian Market be concerned?

ASEAN Free Trade Area

In 1992, Association of South East Asian Nations (ASEAN) Leaders declared that an ASEAN Free Trade Area (AFTA) be established to support local trade and manufacturing and facilitate economic integration with regional and international partners. Since 1992, it is now one of the largest and important free trade areas in the world. AFTA’s primary goals are to increase ASEAN’s competitive edge as a production base in the world market through the elimination of tariffs and non-tariff barriers within ASEAN and to attract more foreign direct investment to ASEAN.

ASEAN Medical Device Directive

To facilitate the realisation of AFTA, the ASEAN Medical Device Directive (AMDD) was agreed to harmonise medical device standards, conformity and regulation across ASEAN countries. Here are some of the provisions under the AMDD agreement that Orthotics and Prosthetics (O&P) companies should take note.

1. Each country ensures that only medical devices which confirm to AMDD standards be allowed into the market.

2. Persons or authorised representatives responsible for placing the medical device in the market must register the medical device and be licensed by the respective country’s Regulatory Authority.

3. Medical device accessories are included and treated as medical devices.

4. Custom-made medical devices are not required to be registered with the Regulatory Authority. However, they must be made according to a medical practitioner’s prescription.

5. Medical devices for clinical investigation must be carried out by a medical practitioner authorised to carry out clinical investigations.

6. Medical Devices are classified into four classes

Class A – Low risk (Most Orthoses and Prostheses are in this class and are exempted from product registration)

Class B – Low-moderate risk

Class C – Moderate-high risk

Class D – High risk

7. Technical documents required include,

a. ASEAN Common Submission Dossier (CSDT)

b. Post Marketing Alert System (PMAS)

c. Product Owner or Manufacturer’s Declaration of Conformity (DoC)

8. Medical Devices must confirm to technical standards recognised by ASEAN Medical Device Committee (AMDC) or by local Regulatory Authority.

9. All medical devices must be labelled accordingly. Some countries may also require labels to the respective national language. (Besides labels, manuals are also required for each device)

10. Claimed benefits of a medical device must be justified by substantial evidence.

LARs, Importers and Distributors

O&P companies wanting to enter the market but are not sure which partners to choose, may first consider using Local Authorised Representatives (LAR). LARs do not necessarily need to be an O&P distributor. It offers companies new to the market, a chance to study the environment while familiarising themselves with customers, distributors, regulatory requirements and competitors. LARs’ main role is to liaise with local authorities on regulatory issues, provide regulatory updates and register licenses on behalf of the overseas company. They can also handle product complaints and adverse event reporting leading to alerts and recalls. To import a product into the market, foreign companies either have to set up their own local office or rely on a local importer partner. Importers are required to possess goods handling certification and be registered and licensed by the local regulatory authority. In most cases, these are O&P workshops. Do note that some O&P workshops keep the products for their own use and do not proactively sell to other workshops. If companies have yet to decide on the right importer/distributor, some LARs also offer importation and distribution services. They own the license to import and distribute the products to any sub-distributor (an O&P workshop). This allows companies to familiarise themselves with the market before identifying and selecting the right partners and distribution channels that best matches their strategy.

Summary

Countries such as Singapore, Malaysia and Indonesia are fully in compliance to the AMDD. Other countries such as Thailand, Philippines and Vietnam will be ready soon. The requirements of the AMDD are not unlike other medical device regulations of developed countries or economic unions. O&P companies wanting to enter the South East Asian market do have to be concerned and should be taking steps to comply with AMDD’s requirements as well as additional regulations from each of the 10 countries before placing their products in the market. Outsourcing LAR, Importer and Distributor services is a prudent way to gain access into new markets.

References

1.       ASEAN Medical Device Directive. ASEAN Secretariat, Jakarta, September 2015
2.       The 1st ASEAN Medical Device Committee (AMDC) meeting and related events. 30 Nov-3 Dec 2015 Kuala Lumpur. T.Sasikala. Medical Device Authority. Ministry of Health Malaysia
3.       South East Asia Free Trade Area. . ASEAN Secretariat, Jakarta. 2002
4.       Health science Authority. Singapore. https://www.hsa.gov.sg/medical-devices/international-collaboration-medical-devices/amdc
5.       Andaman Medical. https://andamanmed.com/
6.       Qualtech. https://www.qualtechs.com/en-gb/what%E2%80%99s-new-in-line-for-the-asean-medical-device-regulations-in-2022-%E2%80%93-november-2021
7.       Freyr. https://www.freyrsolutions.com/what-is-amdd
8.       Baker McKenzie. https://www.globalcompliancenews.com/2019/09/06/asean-medical-device-directive-implementation-updates-20190819/