Following the previous article, this issue continues to break down the registration rules for aesthetic medical devices in two key Southeast Asian markets: Malaysia and Vietnam. Malaysia features a mature and well-established regulatory system with stringent requirements for technical documentation and post-market systems; while Vietnam has a relatively simplified registration process, classification determination and consistency of document entities are among the most common pitfalls.
Simplified pathway significantly cuts timelines: Products holding mainstream overseas certifications such as EU CE marking and US FDA clearance are eligible for a simplified review pathway, which notably shortens approval duration and serves as the core solution to accelerate high-risk device registration.
Unified format standards for technical documentation: The full set of registration materials must be prepared in compliance with the CSDT standard format. The application form, CAB certificate information and technical documentation must be fully consistent with no conflicting information. The technical documentation shall also be highly aligned with the product instructions for use, with zero discrepancies in product models or intended uses.
CAB selection directly impacts project efficiency: When choosing a CAB, it is critical to confirm whether it covers the classification code of the target product, and evaluate the body’s assessment cycle and communication responsiveness. Priority should be given to bodies with proven experience in assessing similar products to ensure steady project progress.
Mandatory post-market surveillance for high-risk products: In accordance with the MDA 2024 PMS Guideline and IMDRF PMS Guideline, high-risk aesthetic medical devices are required to establish a mandatory Post-Market Surveillance (PMS) system. Procedural documents for PMS and Post-Market Clinical Follow-up (PMCF) must be submitted concurrently with the registration application.
Practical pitfalls avoidance tips: Verify the validity of clinical evaluation reports before submission; the cover page of test reports shall clearly indicate the author and date of issuance. Upon receiving the CAB certificate, cross-check all information word by word. If any errors are identified, request corrections immediately with supporting documents to avoid delays in subsequent registration procedures.Vietnam regulates medical devices under Decree No. 98/2021/ND-CP issued by the Ministry of Health. The registration process for Class A and Class B medical devices is relatively simplified, and the overall regulatory framework is aligned with the ASEAN Medical Device Directive (AMDD).
Classification accuracy requires cross-validation: Product risk classification must be determined strictly in line with official classification rules. It is recommended to perform cross-validation by referencing competitor data from Vietnam’s official medical device database and the classification rules of the AMDD, to prevent incorrect registration pathways caused by classification deviations.
Strict control over consistency of document entities: When the manufacturer differs from the registration applicant, it must be ensured that the Free Sale Certificate (FSC) is issued in the name of the registration applicant, and that the company name and address are fully identical to those stated on the ISO certificate. The issuing entity of test reports must also match the registration applicant — entity inconsistency will directly lead to the rejection of application materials.As the largest medical device market in Latin America with the most sophisticated regulatory system, Brazil stands as a core strategic market for Chinese medical device enterprises expanding into South America. To celebrate Wiselink’s 6th anniversary, we are launching a limited-time offer: from June 18 to July 18, a 20% discount on consulting service fees applies to all risk classes of medical device products targeting the Brazilian market. We welcome both new and existing clients to reach out for consultation.
Wiselink拥有包括原澳大利亚药品监督管理局局长Dr. Derrick Beech为首席顾问的国际专业团队，秉承源于澳洲、扎根中国、服务世界的精神，信守专业、真诚、开放的核心价值观，致力于为医疗器械、化妆品、食品、保健品和中药制造商提供全球合规认证和临床试验服务。
Wiselink-全球布局
知汇供应链服务(深圳)有限公司简称Wiselink CN，隶属于澳大利亚Wiselink Group。Wiselink Group总部位于澳大利亚悉尼，全球布局，目前在西班牙、巴西、美国、日本、英国、印尼、新加坡、泰国、新西兰、越南、韩国、马来西亚、中国和中国香港设有14家全资子公司。
Wiselink拥有包括原澳大利亚药品监督管理局局长Dr.Derrick Beech为首席顾问的国际专业团队，秉承源于澳洲、扎根中国、服务世界的精神，信守专业、真诚、开放的核心价值观，致力于为医疗器械、化妆品、食品、保健品和中药制造商提供全球合规认证和临床试验服务。
中国服务热线：400-1168-120
集团总部
Wiselink Group
Level 25 100 Mount Street，North Sydney，NSW Australia 2060
美国子公司
Wiselink Medical Inc
666 Old Country Rd, Suite 201, Garden City, NY 11530
英国子公司
Wiselink Medical (UK) Limited
37 CROYDON ROAD BECKENHAM UNITED KINGDOM BR3 4AB
泰国子公司
Wiselink Medical (Thailand) Company Limited
Two Pacific Place 142 Floor 23th, Sukhumvit Rd, Khlong Toei, Bangkok 10110
新西兰子公司
Wiselink Medical (New Zealand) Limited
11 Bussion Glade, West Harbour, Auckland, 0618, NZ
日本子公司
株式会社Wiselink Japan
〒143-0023 東京都大田区山王2丁目1番8号山王アーバンライフ201号室
越南子公司
Wiselink Medical Company Limited
Floor 18th, TNR Building, 180-192 Nguyen Cong Tru, Nguyen Thai Binh, District 1, Ho Chi Minh City, Vietnam
新加坡子公司
Wiselink Medical (Singapore) Pte.Ltd.
(SG) 08-07,175A, Bulington Square，Bencoolen Street 189650 Singapore
印尼子公司
WISELINK MEDICAL INDONESIA
Ruko Mutiara Taman Palem Blok C.2 No.26
Jalan Lingkar Luar Kamal Raya Blok B.2 No.26，
RT000，RW000，CENGKARENG TIMUR，CENGKAR ENG，3173，31，11730
韩国子公司
주식회사 와이즈링크코리아
서울특별시 송파구 송파대로 111, 204동 1202호(운정동, 파크하비오)
马来西亚子公司
WISELINK MEDTECH SDN. BHD.
OFFICE SUITE 762, AVENUE 7, TOWER 7, LEVEL 7 MENARA PERNAS, THE HORIZON, BANGSAR SOUTH 59200 KUALA LUMPUR W.P. KUALA LUMPUR MALAYSIA
中国香港子公司
知匯醫療(香港)有限公司
Wiselink Medical Development (Hong Kong) Limited
香港湾仔轩尼诗道253-261 号依时商业大厦 1002 室
Rm.1002, 10/F, Easey Comm. Bldg., 253-261 Hennessy Road, Wanchai, Hong Kong
中国子公司
知汇供应链服务（深圳）有限公司
深圳市宝安区新安街道稻兴环球科创中心A座1810-1812室
官网：http://www.wiselinkchina.com
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