[APACMed]

APACMed Regulatory News #6

1. Regulatory Intelligence

Brunei Darussalam

Currently, there are no mandatory requirements for product registration, business licensing or post marketing surveillance in Brunei Darussalam. According to the Healthcare Technology Department in Ministry of Health, a draft of Medical Device Regulation Order was submitted to Attorney General's Chambers (AGC) in 2017 and the regulation will be developed by end of 2018.

China 

On 29 March 2018, China’s Center for Medical Device Evaluation (CMDE) organized a one-day pro bono training on two recently published guidelines, The Guidelines for Designing Clinical Trials of Medical Devices and The Guidelines for Accepting Overseas Clinical Data of Medical Devices, attended by over 540 people from government, hospitals, industry, and consulting firms. The lecturers were CMDE reviewers, covering topics including How to evaluate the safety and efficacy based on the checklist, Basic requirements for clinical evaluation, as well as interpretations for the above-mentioned two guidelines (PowerPoint is available upon request). 

The China Food and Drug Administration (CFDA) issued a draft on Guidelines for technical review of 3D printing medical device registration for public consultation and organized a panel discussion with the 3D Printing Device Committee of China Association for Medical Devices Industry (CAMDI) to collect further comments.

CFDA also published two draft documents on Unique Device Identification (UDI) for public comments:
- Rules of UDI system(deadline: 30 April);
- Industry Standard of General Requirements for UDI(deadline: 13 May).

APACMed plans to sponsor the 9th China International Medical Device Regulatory Forum (CIMDR) organized by CCFDIE on 14-16 September 2018 in Fuzhou, China. The RA Committee will prioritize its strategies based on the regulatory reforms in China.

India

TheMedical Device Rules 2017 released by India’s Ministry of Health and Family Welfare took effect on January 1, 2018. Upon implementation, this regulation replaced the existing Drugs and Cosmetics Rules (1945) as it pertained to medical devices and IVDs. The new rules attempt to establish a uniform regime for Indian medical device manufacturing and marketing. The licenses and registration certificates issued under existing rules shall continue to be valid till July 2018 or their expiry, whichever is later. On 16 March 2018, the Grouping Guidelines for Medical Devices Applications was issued with a FAQ by the Ministry.

On 1 November 2017, the Drugs Controller General (India)(DCGI) published the final List of Medical Devices and In Vitro Diagnostics along with their risk class as per the provisions of Rule 4 of the Medical Devices Rules 2017. This list comprises 351 medical devices and 247 in vitro diagnostic medical devices. On 21 February 2018, DCGI issued a Notice regarding Finalization of audit fee of Notified Bodies.

Recently, a Frequently Asked Questions on In-Vitro Diagnostic Devices (Doc No.: CDSCO/IVD/FAQ/02/17) and a Frequently Asked Questions on Medical Device Rules 2017 (Doc No.: CDSCO/FAQ/MD/01/2018) were released by Central Drugs Standard Control Organization (CDSCO).

Indonesia

On 13 January 2018, the new Minister of Health Regulation No. 62, 2017: Regarding Marketing Authorization of Medical Devices, IVD Medical Devices and Household Health Products was issued. Two other relevant regulations released last year were the Minister of Health Regulation No. 63, 2017: Regarding Good Clinical Practice for Medical Devices and the Minister of Health Regulation No. 60, 2017 regarding the supervision of Trade System of Imported Medical Devices, IVD Medical Devices and household health products.

Besides, Indonesia also adopted the Minister of Health Regulation No. 20, 2017: regarding Good Manufacturing Practices of Medical Devices (CPAKB), mandating all medical device industries to implement GMP MD(CPAKB) within 4 years (latest 2021).

Japan

Pharmaceuticals and Medical Devices Agency (PMDA) plans to establish a Regulatory Science Center in April 2018, to actively collect and utilize scientific knowledge of quality, efficacy and safety especially derived from the “Real World Data”. PMDA is also planning to adapt its review and consultation services to consider AI utilization as a new factor in medical device reviews, starting from diagnostic imaging products.

Malaysia 

According to the Medical Device Authority (MDA), full enforcement of medical device registration requirements as specified under Section 5 of the Medical Device Act 2012 (Act 737) is projected to go ahead in July 2018 with no further extension despite concerns about backlog.

After 1st July 2018, only the license establishment certificate and the medical device registration certificate are acceptable as supporting documents in the procurement process of medical devices in any health facility institution and distribution of devices in the country. The acknowledgement letters are no longer valid for use as a supporting document after this date.

The new document MDA/GD/0026 Requirements for Labeling of Medical Devices will be effective in August 2018. Concerns were raised about solutions to existing stock (field and warehouse) and whether the requirements should be applied for export-only products manufactured in Malaysia. The RA Committee plans to work with AMMI in organizing a workshop to understand the solution on labeling requirements implementation which can be presented to MDA.

Philippines

On 26 January 2018, the Philippines Department of Health issued Administrative Order 2018-0002, Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements, effective in March 2018. But the implementation date will be March 2019 or even later. The new Order shall apply to all medical devices to be sold, imported, exported, manufactured, or used in the Philippines, except for IVDs and refurbished medical devices, for which separate Administrative orders will be issued.

According to Center of Device Regulation, Radiation Health, and Research (CDRRHR), this Administration Order shall cover initially all registrable products listed in FDA Memorandum Circular No. 2014-005: Updated List of Medical Devices required to be registered prior to sale, distribution and use and its amendments. The regulator is expected to start implementing the Notification for all class A medical devices, followed by 3 Phases: notification of Class B, C, and D that are no-registrable medical devices based on Circular No. 2014-005; registration of Class D; registration of Class B and Class C.

The RA Committee is planning to meet with CDRRHR to understand more about implementation of the new regulation and potential barriers.

Singapore 

The Health Sciences Authority (HSA) will strive to improve clarity and transparency in on the scope of regulatory controls, strengthen the post-market compliance monitoring to balance the life cycle regulatory approach, and to improve accessibility to safe and innovative medical devices for patients. The key upcoming updates will include guidance documents on essential principles for safety and performance, labeling, product registration, and change notification.

South Korea

In the past few months, the Ministry of Food and Drug Safety (MFDS) issued a series of new guidelines for 3D-printed Devices and innovative products, including Guideline on Review & Approval for Big Data & AI-applied Medical Devices, Guideline on Clinical Evaluation of Validity for Artificial Intelligence (AI) Medical Devices, and Guideline on Cancers, Genetic Disorders and Congenital Anomaly Test on Fetus as per Testing Types of NGS Clinical Laboratories.

MFDS also issued a draft of Special Act for Innovative Devices to expedite the review process, customize safety management system, and enhance capacity building for regulatory and technological expertise. There is another draft of In Vitro Diagnostic Device (IVD) Act with customized management principles to reflect unique characteristics of IVDs, including improved clinical trial regulations, clinical lab accreditation program & approval system, and simultaneous review system for IVD companion diagnostic devices (CDx).

MFDS is also planning to implement a UDI system for medical devices in the very near future, probably starting with Class 4 in 2019, then expand to Class 3 and Class 2, and eventually to all classes. MFDS has an affiliated Medical Device Information Technology Assistance Center (MDITAC) to manage the UDI system, analyzing and processing the collected data, and has established a Medical Device Information Integration Center to provide help desk service on the UDI system.

Sri Lanka

The National Medicines Regulatory Authority (NMRA) in Sri Lanka requested (effective from 15 August 2017) all importers who submit applications for registration of medicinal products and medical devices to submit the following supporting documents from the manufacturer: CIF price of the product; Regional price of the product (eg. SAARC countries); Price of the product in the country of origin; Documentary evidence to prove the above prices (invoices).

Currently, it is mandatory to submit the above-mentioned documents for price-controlled products. But for other products, a letter of clarification (with confidential / legal reasons) from the manufacturer is well accepted by reviewers at NMRA. The RA committee is planning to work with the GA committee as a joint effort to engage local stakeholders and propose mitigation measures.

Thailand 

Based on the draft amendment to the Medical Device Act (2008) approved in principle by the Cabinet, Thailand enhanced the approval process for health products including medical devices based on NCPO Order No. 77/2559 Re: Increasing the Efficiency of the Health Products Approval Process.

Looking ahead, the Thai FDA is planning to update the regulations to add approval process improvement, and then submit it to the Cabinet for consideration this year. The RA Committee is planning to meet with the new medical device director within Thai FDA to discuss the opportunityopportunities for partnership and understand more about status on implementation of the new regulation.

Vietnam

The Ministry of Health delayed full implementation of Decree No. 36/2016 /ND-CP for medical device class B, C, and D for another year to 1 January 2019 based on Resolution No. 131/NQ-CP. With the extension, medical devices can still be circulated as per Circular No. 30/2015/TT-BYT where import license as per Circular No. 30/2015/TT-BYT will still be valid. The registration of IVDs shall comply to Circular 44/2014/TT-BYT and the importation shall follow Circular 47/2010/TT-BYT until 31 December 2018.

In parallel, the Ministry of Health plans to submit a draft Decree amending and supplementing Decree No. 36/2016/ND-CP to the Government in the third quarter of 2018. It is currently in the second round of public consultations. The RA Committee is working with local associations to collate and compile comments, and intends to meet with Department of Medical Equipment and Construction (DMEC) to discuss about the implementation plan, and its associated challenges.

In addition, we recently received a draft of the GUIDELINES FOR EVALUATION OF REGISTRATION DOSSIERS for IN VITRO DIAGNOSTIC MEDICAL DEVICES for dossier regulated in Article 26 of Decree No. 36/2016/ND-CP from the Ministry of Health. According to the draft, the list of documents requested for IVD registration is more extensive than the CSDT list. The RA Committee with the newly established IVD Working Group is working to engage the regulators and other stakeholders.