Regulation in South-East Asia Joint Drugs Controller (India) Dr. K. Bangarurajan Joint Drugs Controller (India) CDSCO, DGHS, MoHFW, GOI bangaru@cdsco.nic.in

Introduction WHO SEARO provides leadership on health matters, articulates evidence-based policy options, provides technical support to countries and monitors health trends. WHO South-East Asia Region has 11 Member States: 1. Bangladesh 2. Bhutan 3. Democratic People’s Republic of Korea 4. India 5. Indonesia 6. Maldives 7. Myanmar 8. Nepal 9. Sri Lanka 10. Thailand 11.Timor-Leste Most of SEACs have well established regulatory framework for medicine/vaccine regulation but only India, Indonesia and Thailand has well developed regulation and regulatory system in place for medical devices.

Evaluation of Applications by IND/SECs Medical Device Regulation in India Medical Device Rules, 2017 Medical Device Rules, 2017 under the provisions of the Drugs and Cosmetics Act, 1940 has been published, vide GSR 78(E) dated 31.01.2017 which is implemented w.e.f. 01.01.2018. The said Rules overrides all the previous notifications issued under the D&C Rules,1945 related to the regulations of medical devices. The said rules have provisions for the regulation of devices for their import, manufacture, clinical investigation and sale.

Risk Based Classification Notified Body: Conformity Assessment Process Medical Devices Rules, 2017 NB to audit Class A & B devices based on Schedule -5 and Schedule 4 requirements An audit report and Technical review of documents to be provided to SLA/CLA for issue of license No certificate is provided by NB to the manufacturer since the license is issued by the SLA/CLA to the manufacturer and is perpetual No surveillance audit is required to be carried out by NB post audit or technical file assessment Class A – Sterile/Measuring devices – is there a requirement of Schedule-4? Conformity assessment route Risk Based Classification (MD & IVD) Class A – Low Risk Class B – Low moderate Risk Class C – Moderate high Risk Class D – High Risk Class A – Post license approval by NB via Schedule 4 + Schedule 5 Class B – Pre-approval by NB via Schedule 4 + Schedule 5 Class C&D – Pre-approval by CLA via Schedule 4 + Schedule 5 (based on inclusion for NBs by CDSCO) SLA Class A/B Manufacturer CLA Class C/D Importer/ Authorized Agent Pre-approval for all Class through GHTF + FSC TF review Clinical Investigation may be required for Class C/D based on CLA discretion CLA Class A/B/C/D Central Licensing Authority (CLA) for all classification (no NB involvement) 5 SLA = State Licensing Authority (State-SLA) CLA = Central Licensing Authority (CDSCO)

Licensing Authorities Application for Import, manufacture, Clinical Investigation/Performance evaluation of new IVD/MD of Class C and Class D , test licence, Free Sale Certificate, and personal use will be submitted to CLA through online portal. Inspection of manufacturing site will be carried out by Drugs Inspectors. Application for manufacture of Class A and Class B devices will be submitted to SLA through online portal. Audit of manufacturing site will be carried out by Notified Bodies.

Standards of medical devices i. BIS or those set by Central Government ii. Failing (i) by International Organisation for Standardisation (ISO) or International Electro Technical Commission (IEC) iii. Failing both, manufacturers validated standards.

Thailand Medical Device Regulations Thailand’s Food and Drug Administration (FDA) is the chief regulatory agency for health products in the country The FDA is responsible for pre-market controls, post-market controls, and adverse effects surveillance  The Medical Device Control Division regulates medical devices in accordance with the Medical Device Act

Indonesia Medical Device Regulations The National Agency of Drug and Food Control (NA-DFC) is responsible for the supervision of drugs and medical devices in Indonesia. While Indonesia has no specific regulations for medical devices, it has implemented global quality norms such as ISO 13485 in an attempt to harmonize its regulations with existing international law.

ASEAN Medical Device Regulations The Association of Southeast Asian Nations (ASEAN), which is comprised of the countries Indonesia, Malaysia, Philippines, Singapore, Thailand, Vietnam, Brunei, Laos, Myanmar, and Cambodia, was established in 1967 to promote peace and stability in the region. In 2015, the Association of Southeast Asian Nations (ASEAN) signed an agreement, formally called the ASEAN Medical Device Directive (AMDD), that aimed to harmonize medical device regulations.  The AMDD provides a more straightforward path to the market for medical device manufacturers. An important element of the AMDD is the ASEAN Common Submission Dossier Template (CSDT), a collection of information and requirements that allows a device manufacturer to provide the same body of product registration documentation to the different regulatory authorities of the ASEAN member states.

Cont...... Use of the CSDT (Common Submission Dossier Template)  helps to reduce costs for manufacturing companies seeking to obtain device approval in any of the ten ASEAN countries. The AMDD classifies medical devices into four classes based on risk level. Class A products are low risk, Class B products are low-moderate risk, Class C products are moderate-high risk, and Class D products are high risk.

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