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

3. 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 Bhutan
3. Democratic People’s Republic of Korea
4. India Indonesia Maldives Myanmar
8. Nepal Sri Lanka 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.

4. 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 which is implemented w.e.f
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.

5. 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)

6. 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.

7. 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.

8. 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

9. 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 in an attempt to harmonize its regulations with existing international law.

10. 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.

11. 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.